{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-11", "results": { "skip": 0, "limit": 100, "total": 1173 } }, "results": [ { "effective_time": "20120120", "inactive_ingredient": [ "Inactive ingredient Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil and Polyethylene Gycol *This product is not manufactured or by Purdue Frederick, owner of the registered trademark Senokot® Manufactured by: Contract Pharmacal Corp. 135 Adams Avenue Hauppauge, NY 11788 USA www.cpc.com R11/09" ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than one week unless directed by a doctor" ], "spl_product_data_elements": [ "Natural Senna Sennosides SENNOSIDES A AND B SENNOSIDES CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POLYETHYLENE GLYCOL 400 Mottled brown 1122" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea, or vomiting, noticed a sudden change in bowel habits that continue over a period of 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions preferable at bedtime adults – two tablets: maximum of 4 tablets twice daily children (6-12 years) one tablet: maximum 2 tablets twice daily Other information Store at room temperature, USP Contains 20 mg of calcium Side effects occur. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free)." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative These may indicate a serious condition." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL f4a8921b-figure-01" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours" ], "set_id": "002621a1-0f13-4e92-856b-5a850a48193e", "id": "f4a8921b-1b27-4768-887a-81bad872a378", "active_ingredient": [ "Active ingredient (in each rounded tablet) Sennosides from Senna Concentrate 8.6 mg" ] }, { "effective_time": "20140814", "purpose": [ "Active Ingredients Purpose The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States. Borax 30C HPUS To reduce motion sickness Cocculus Indicus 30C HPUS Gelsemium 30C HPUS Kressotum 30C HPUS Rhus Toxicodendron 30C HPUS Tabacum 30C HPUS" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other Information Store under 86°F (30°C) No drug interactions Non-drowsy" ], "indications_and_usage": [ "Uses For the relief of motion sickness associated with traveling" ], "set_id": "0034b407-fd1d-4e69-a468-83fe4e3c5aad", "id": "977f1de9-3567-4053-ac35-eeb15012f936", "active_ingredient": [ "Active Ingredients Purpose The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States. Borax 30C HPUS To reduce motion sickness Cocculus Indicus 30C HPUS Gelsemium 30C HPUS Kressotum 30C HPUS Rhus Toxicodendron 30C HPUS Tabacum 30C HPUS" ], "dosage_and_administration_table": [ "
Age Dose
Adults and Children 2 years and over Chew one tablet at start of trip, and one tablet every hour while problem persists. However variation of these directions is acceptable and may be preferable. Best if taken 1 hour before and after meals.
Under 2 years Ask a doctor.
" ], "inactive_ingredient": [ "Inactive ingredients Dextrose and separating agents magnesium stearate and silicon dioxide." ], "warnings": [ "Warnings Do not use if the blister pack is broken. Ask a doctor before use in children under 2 years of age. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "TRIP EASE SODIUM BORATE, ANAMIRTA COCCULUS SEED, GELSEMIUM SEMPERVIRENS ROOT, WOOD CREOSOTE, TOXICODENDRON PUBESCENS LEAF, AND TOBACCO LEAF SODIUM BORATE BORATE ION ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT WOOD CREOSOTE WOOD CREOSOTE TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF TOBACCO LEAF TOBACCO LEAF Dextrose Silicon Dioxide Magnesium stearate ML" ], "ask_doctor": [ "Ask a doctor before use in children under 2 years of age." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Age Dose Adults and Children 2 years and over Chew one tablet at start of trip, and one tablet every hour while problem persists. However variation of these directions is acceptable and may be preferable. Best if taken 1 hour before and after meals. Under 2 years Ask a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Distributed to retailers by L.C. Industries, Inc Elk Grove Village, IL 60007" ], "stop_use": [ "Stop use and ask a doctor if symptoms persist for more than 3 days or worsen." ], "do_not_use": [ "Do not use if the blister pack is broken." ], "active_ingredient_table": [ "
Active Ingredients Purpose
The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States.
Borax 30C HPUS To reduce motion sickness
Cocculus Indicus 30C HPUS
Gelsemium 30C HPUS
Kressotum 30C HPUS
Rhus Toxicodendron 30C HPUS
Tabacum 30C HPUS
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 32 Tablet Blister Pack Carton Made in New Zealand Net 32 Tablets NDC 59672-0732-2 TRIP EASE™ Homeopathic Motion Sickness Relief Safe • Natural • Effective • No Side Effects or Drug Interactions Principal Display Panel - 32 Tablet Blister Pack Carton" ], "purpose_table": [ "
Active Ingredients Purpose
The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States.
Borax 30C HPUS To reduce motion sickness
Cocculus Indicus 30C HPUS
Gelsemium 30C HPUS
Kressotum 30C HPUS
Rhus Toxicodendron 30C HPUS
Tabacum 30C HPUS
" ] }, { "effective_time": "20120810", "inactive_ingredient": [ "INACTIVE INGREDIENTS aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date. Distributed by McKesson One Post Street, San Francisco, CA 94104 www.healthmart.com/healthmartbrand" ], "spl_product_data_elements": [ "HealthMart Loratadine ODT Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White flat faced beveled edge RC17" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. keep in a dry place. use tablet immediately after opening individual blister." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Health Mart ® PHARMACY NDC 62011-0073-1 allergy relief loratadine orally disintegrating tablets, 10 mg/antihistamine indoor & outdoor allergies melts in your mouth without water for adults & children 6 years and older 24 hour relief of: sneezing/runny nose/itchy, watery eyes/itchy throat or nose non-drowsy * 10 orally disintegrating tablets * When taken as directed. See Drug Facts Panel. compare to Claritin ® RediTabs ® active ingredient † † The product is not manufactured or distributed by Schering-Plough Healthcare Products , Inc. CLARITIN ® and REDITABS ® are registered trademarks of Schering Corporation. This is the 10 count blister carton label for Health Mart Loratadine ODT, 10 mg." ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "005948c5-97fe-4f07-81bb-33a691261c51", "id": "47949aaf-807a-4b1a-96e6-2e4f9fe836b5", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20100526", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1 800 719-9260 This product is manufactured by: Perrigo Company 515 Eastern Avenue Allegan Michigan 49010 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "00608f79-20db-4a7d-a204-89779f01ad48", "id": "f9604c52-0f89-43dc-8be9-e478db8f029e", "active_ingredient": [ "Active Ingredient (in each tablet) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO L612" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease.Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature)." ], "how_supplied_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0457-1 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650
" ], "how_supplied": [ "How supplied They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0457-1 10 mg 30 Tablets in a Blister Pack WHITE 45802-0650" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "10 mg Label NDC 53808-0457-1 Non-Drowsy* LORAtadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose * When taken as directed. See Drug Facts Panel. Loratadine 10 mg Label" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dose." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Suphedrine PE Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM DEXTROSE MONOHYDRATE CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE 44;453" ], "ask_doctor": [ "Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use this product in children under 12 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel SAFETY SEALED Relieves Nasal and Sinus Congestion Due to Colds and Allergies Our Family® Quality Care Since 1904 Compare to the Active ingredient of Sudafed PE®* Suphedrine PE PHENYLEPHRINE HYDROCHLORIDE NASAL DECONGESTANT WITHOUT DROWSINESS 18 TABLETS Does not contain Pseudoephedrine 1 Pill Per Dose 10 mg EACH TAMPER EVIDENT: DO NOT USE IF CATON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®. 50844 REV1111E45344 DISTRIBUTED BY: NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF16559 Our Family 44-453 Our Family 44-453" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "008d8e72-739e-4ee3-b094-3cd93f5b66b1", "id": "cd6ec58d-c089-4ae7-a8da-3f64c0bba2d7", "active_ingredient": [ "Active ingredient (in each tablet) Phenylephrine HCl 10 mg" ] }, { "effective_time": "20121129", "inactive_ingredient": [ "Inactive Ingredients: Acacia gum, lactose, magnesium stearate, starch, sucrose." ], "purpose": [ "Temporarily relieves dizziness and nausea" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children." ], "warnings": [ "Warnings: If symptoms persist or worsen, consult a healthcare professional." ], "spl_product_data_elements": [ "VertiFree Bryonia , Cocculus, Gelsemium, Lobelia inf, Acacia gum, lactose, magnesium stearate, corn starch, sucrose BRYONIA ALBA ROOT BRYONIA ALBA ROOT ACACIA LACTOSE MAGNESIUM STEARATE STARCH, CORN SUCROSE ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT LOBELIA INFLATA LOBELIA INFLATA white lactose tablets round white lactose tablets none" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Chew or dissolve tablets in the mouth.Alternatively, for small babies, crush tablets and sprinkle onto tongue or mix in warm water or soft food.For all ages: Takes 2 tablets 3 times daily until symptoms subside." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use." ], "storage_and_handling": [ "Tamper resistant for your protection. Use only if safety seal is intact." ], "information_for_patients": [ "The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States. All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com Distributed by Native Remedies, LLC 6531 Park of Commerce Blvd. Suite 160 Boca Raton, FL 33487 Phone: +1.877.289.1235 International:+1.561.99.8857 Contains no artificial flavors or artificial colors. No gluten added." ], "package_label_principal_display_panel": [ "Bottle Label" ], "indications_and_usage": [ "Uses: Homeopathic remedy for the temporary symptom relief of dizziness and nausea." ], "set_id": "00962471-6362-4353-9439-6711ed5ef694", "id": "c49d071d-21cd-443c-a782-8867b0c9dc7c", "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away." ], "active_ingredient": [ "Active Ingredients: Each tablet contains equal parts of: Bryonia (30C) (HPUS), Cocculus (30C) (HPUS), Gelsemium (30C) (HPUS), Lobelia inf (30C) (HPUS)." ] }, { "effective_time": "20130627", "purpose": [ "Purpose Pain reliever/Fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions 1-888-291-7337" ], "pregnancy_or_breast_feeding": [ "Pregnancy/Breastfeeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Storage store between 20-25 °C (68-77 ° F)." ], "indications_and_usage": [ "Use(s) temporarily relieves minor aches and pain due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever" ], "set_id": "00bc1e01-f90e-444d-b7d6-807797a1d136", "id": "c265106e-3575-4073-8195-0aa0adb10f45", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient(s) Ibuprofen 200 mg (NSAID)* * nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
adults and children 12 years and older: · take 1 tablet every 4 to 6 hours while symptoms persist · if pain or fever does not respond to 1 tablet, 2 tablets may be used · do not exceed 6 tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredient colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) blisters facial swelling hives rash shock skin reddening If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product the more or for a longer time than directed" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM COLLOIDAL SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE STARCH, CORN POLYVINYL ALCOHOL 114 Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM COLLOIDAL SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE STARCH, CORN POLYVINYL ALCOHOL 117" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems such as heartburn the stomach bleeding warning applies to you you have high blood pressure, heart disease , kidney disease, liver cirrhosis you are taking a diuretic you have asthma" ], "other_safety_information": [ "other information do not use if seal under cap is broken or missing see end panel for lot number and expiration date" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older: · take 1 tablet every 4 to 6 hours while symptoms persist · if pain or fever does not respond to 1 tablet, 2 tablets may be used · do not exceed 6 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor" ], "stop_use": [ "Stop use and ask doctor if you experience any of the following signs of stomach bleeding: ● feel faint ●vomit blood● have bloody or black stools ● have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms occur Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel CARTON LABEL PDP NDC: 52605-114-01 Compare to the active ingredient in Advil ® IBUPROFEN TABLETS, USP 200 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) 100 COATED TABLETS SEE NEW WARNINGS INFORMATION BOTTLE LABEL PDP NDC: 52605-114-01 IBUPROFEN TABLETS, USP 200 mg PAIN RELIEVER/ FEVER REDUCER(NSAID) 100 COATED TABLETS SEE NEW WARNINGS INFORMATION CARTON LABEL PDP NDC: 52605-117-01 Compare to the active ingredient in Advil ® IBUPROFEN TABLETS, USP 200 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) 100 COATED CAPLETS SEE NEW WARNINGS INFORMATION BOTTLE LABEL PDP NDC: 52605-117-01 IBUPROFEN TABLETS, USP 200 mg PAIN RELIEVER/ FEVER REDUCER(NSAID) 100 COATED CAPLETS SEE NEW WARNINGS INFORMATION Ibuprofen ibu200tabbottlab ibucarton100 ibubott100" ] }, { "effective_time": "20151016", "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetamminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets wrse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? Call 1-888-309-9030" ], "spl_product_data_elements": [ "Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STEARIC ACID TITANIUM DIOXIDE 44;464" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions do not use more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets wrse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 59º-77ºF in a dry place see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. CVS® pharmacy Compare to the active ingredients in Benadryl® Allergy Plus Sinus Headache* See New Warnings Information ALLERGY & SINUS HEADACHE PAIN & PRESSURE RELIEF PAIN RELIEVER / ANTIHISTAMINE / NASA: DECONGESTANT Acetaminophen Sinus Headache Phenylephrine HCl Sinus Congestion Sinus Pressure Diphenhydramine HCl Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat 24 CAPLETS TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0410B46408 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2010 CVS/pharmacy www.cvs.com 1-800-shop-CVS Product Packaging Product Packaging" ], "indications_and_usage": [ "Use(s) temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes" ], "set_id": "00e13779-2592-23f8-9a0e-6a6c6d4ece1d", "id": "de852971-a813-4fa4-9138-b43a4397b6e2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(s) Acetaminophen 500 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20130527", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery." ], "questions": [ "Questions or comments? call toll free 1-800-206-7821" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F)." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "set_id": "010ea8e3-4955-4332-8cca-f45977ab56c6", "id": "010ea8e3-4955-4332-8cca-f45977ab56c6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine hydrochloride USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN LACTOSE MONOHYDRATE POVIDONE K29/32 MAGNESIUM STEARATE S;521" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 16714-271-02 Cetirizine Hydrochloride Tablets, USP 10 mg 6 Years and Older Allergy Antihistamine 24 Hour Relief of • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat NORTHSTAR 100 Tablets Cetirizine HCl 10mg Tablets #30" ] }, { "effective_time": "20120910", "inactive_ingredient": [ "INACTIVE INGREDIENTS Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide" ], "purpose": [ "PURPOSE Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ranitidine Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE RANITIDINE COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TALC TITANIUM DIOXIDE OR;606" ], "ask_doctor": [ "Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL QC QUALITY CHOICE ® NDC 63868-711-30 * Compare to the active ingredient in Zantac 75 ® REGULAR STRENGTH HEARTBURN 75 RANITIDINE TABLETS, USP 75 mg ACID REDUCER Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach 30 Tablets © DISTRIBUTED BY QUALITY CHOICE 5096945 0712 This is the 30 count bottle carton label for Quality Choice Ranitidine tablets USP, 75 mg." ], "indications_and_usage": [ "USES relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages" ], "set_id": "012fa171-a486-4029-b68e-f38432fbf8aa", "id": "1300e024-05f2-4280-aa5f-fbbd17b3b0b8", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 mg)" ] }, { "effective_time": "20150428", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-343-7805" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) do not use if imprinted foil inner seal on bottle is broken or missing" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "02202313-75fa-43e7-b647-4b6f68780f86", "id": "8e6594e2-8d36-4b9b-8c32-d48a5f11d9a9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Zyrtec Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE rounded-off rectangular biconvex tablet ZYRTEC;10;MG" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1000", "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "Label" ] }, { "effective_time": "20130507", "inactive_ingredient": [ "INACTIVE INGREDIENTS Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide" ], "purpose": [ "PURPOSE Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not use more than directed Stop use and ask a doctor if symptoms do not get better within 7 days or occur with a fever you get nervous, dizzy, or sleepless If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CASTOR OIL COLLOIDAL SILICON DIOXIDE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE TITANIUM DIOXIDE 204" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if symptoms do not get better within 7 days or occur with a fever you get nervous, dizzy, or sleepless" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 59° to 77° F in a dry place protect from light TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 41250-204-69 Compare to Sudafed ® 12 Hour active ingredient * meijer ™ Non-Drowsy Maximum Strength 12 Hour Decongestant Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP Long-Acting Nasal Decongestant Nasal & Sinus Congestion Due to Colds & Allergies Sinus Pressure 10 Coated Capsule-Shaped Tablets 120 mg Each DIST. BY MEIJER 5102550/R0413 10's blister carton label" ], "indications_and_usage": [ "USES Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure" ], "set_id": "037b997a-629c-4533-897c-6fb73d256a56", "id": "4db261d9-f850-460f-a2b9-3d97bc042944", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Pseudoephedrine HCl USP, 120 mg" ] }, { "effective_time": "20130722", "spl_unclassified_section_table": [ "
Supplement Facts
Serving Size: 2 Tablets
Servings Per Container: 20
Amount Per Serving % Daily Value
Calories 8
Sugars 2 g
Calcium 540 mg 54%
Sodium Sodium Free 0%
" ], "purpose": [ "Active ingredients (in each tablet) Purpose Calcium carbonate 675 mg Antacid Magnesium hydroxide 135 mg Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "questions": [ "Questions or comments? call 1-800-223-0182" ], "storage_and_handling": [ "Other information each tablet contains: calcium 270 mg, magnesium 55 mg store between 20-25°C (68-77°F). Avoid high humidity. do not use if roll wrap is open or torn see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms", "USES As a daily source of extra calcium." ], "set_id": "03d20f09-f3eb-4ffd-ab9a-5808b65a86e6", "id": "9353f546-33fa-485b-b64d-6d327155eef7", "active_ingredient": [ "Active ingredients (in each tablet) Purpose Calcium carbonate 675 mg Antacid Magnesium hydroxide 135 mg Antacid" ], "dosage_and_administration_table": [ "
Supplement Facts
Serving Size: 2 Tablets
Servings Per Container: 20
Amount Per Serving % Daily Value
Calories 8
Sugars 2 g
Calcium 540 mg 54%
Sodium Sodium Free 0%
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, dextrose excipient, flavor, magnesium stearate, pregelatinized starch" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 10 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Keep out of reach of children" ], "spl_product_data_elements": [ "Rolaids Extra Strength Calcium carbonate and magnesium hydroxide Calcium carbonate Carbonate ion Magnesium Hydroxide Hydroxide ion ACESULFAME POTASSIUM MAGNESIUM STEARATE Troche R Freshmint" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions chew 2 to 4 tablets, hourly if needed", "DIRECTIONS Chew 2 tablets twice daily. Supplement Facts Serving Size: 2 Tablets Servings Per Container: 20 Amount Per Serving % Daily Value Calories 8 Sugars 2 g Calcium 540 mg 54% Sodium Sodium Free 0%" ], "spl_unclassified_section": [ "Drug Facts", "CALCIUM SUPPLEMENT USES As a daily source of extra calcium. DIRECTIONS Chew 2 tablets twice daily. Supplement Facts Serving Size: 2 Tablets Servings Per Container: 20 Amount Per Serving % Daily Value Calories 8 Sugars 2 g Calcium 540 mg 54% Sodium Sodium Free 0%" ], "do_not_use": [ "Do not take more than 10 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician." ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Calcium carbonate 675 mg Antacid
Magnesium hydroxide 135 mg Antacid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL EXTRA STRENGTH NDC 50580-746-40 Rolaids ® Antacid/Calcium Supplement FAST ACTING Relieves Heartburn Acid Indigestion 4 Rolls 40 Total Tablets Freshmint Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Calcium carbonate 675 mg Antacid
Magnesium hydroxide 135 mg Antacid
" ] }, { "effective_time": "20140925", "inactive_ingredient": [ "INACTIVE INGREDIENTS Lactose Magnesium stearate" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children" ], "purpose": [ "PURPOSE For the temporary relief of minor: Joint pain, Back pain, Muscular pain" ], "warnings": [ "WARNINGS If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a health professional shoul be consulted. Do not use if known sensitivity to T-Relief™ or any of its ingredients exists." ], "spl_product_data_elements": [ "T Relief T Relief MAGNESIUM STEARATE CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP HYPERICUM PERFORATUM HYPERICUM PERFORATUM BELLIS PERENNIS BELLIS PERENNIS MATRICARIA RECUTITA MATRICARIA RECUTITA ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ACHILLEA MILLEFOLIUM ACHILLEA MILLEFOLIUM LACTOSE BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT ATROPA BELLADONNA ATROPA BELLADONNA RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP COMFREY ROOT COMFREY ROOT ACONITUM NAPELLUS ACONITUM NAPELLUS ARNICA MONTANA ARNICA MONTANA radiant;man" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dose. Do not exceed 12 tablets in 24 hours. Children 4 to 11 years : 1 tablet every 1/2 to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours. Standard Dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. Children 4 to 11 years: 2 tablets per day, taking 1 tablet every 6 to 8 hours. For children under 4 years , consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow." ], "package_label_principal_display_panel": [ "T-Relief Tablet T-Relief Tablet" ], "indications_and_usage": [ "Indications Relieves joint pain back pain muscular pain" ], "set_id": "03e598d8-8da3-2dd0-e054-00144ff88e88", "id": "03e598d8-8da4-2dd0-e054-00144ff88e88", "active_ingredient": [ "ACTIVE INGREDIENTS *Aconitum napellus 3X, *Arnica montana, radix 3X, *Arnica montana, radix 6X, *Arnica montana, radix 10X, *Baptisia tinctoria 2X, *Belladonna 3X, *Bellis perennis 2X, *Calendula officinalis 2X, *Chamomilla 2X, *Echinacea 2X, *Hamamelis virginiana 2X, *Hypericum perforatum 3X, *Millefolium 2X, *Ruta graveolens 4X, *Symphytum officinale 8X *Natural Ingredients" ] }, { "effective_time": "20130114", "inactive_ingredient": [ "INACTIVE INGREDIENTS Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White Flat Faced Beveled Edge RC17" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. keep in a dry place. use tablet immediately after opening individual blister." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Compare to the active ingredient of Alavert ®† CAREONE ® Original Prescription Strength Non-Drowsy * 24 hour ALLERGY RELIEF Loratadine Orally Disintegrating Tablets, 10 mg/Antihistamine Indoor & Outdoor Allergies NO WATER NEEDED · MELTS IN YOUR MOUTH FOR ADULTS AND CHILDREN SIX YEARS AND OLDER! Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat 24 Orally Disintegrating Tablets * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: AMERICAL SALES COMPANY 5080283/R0211 This is the 24 count blister carton label for Careone Loratadine ODT, 10 mg." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "04a54364-7f13-4b23-8445-9cbc57733e18", "id": "b9692ba4-8ebc-40db-a9e0-87a4369f5fc1", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps" ], "spl_product_data_elements": [ "Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Temporary Relief of Occasional Constipation Compare to the Active Ingredient of Ducolax®* Gentle Laxative Bisacodyl Stimulant Laxative 25 Tablets 5 mg each TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF00000 50844 REV0510B32765 Our Family 44-327-56 Product Label" ], "indications_and_usage": [ "Use(s) relieves occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "050780d6-b1bd-4717-b517-527b86bb9dfa", "id": "aa329d94-d60c-4a9b-aebd-d707ba6bedb1", "active_ingredient": [ "Active ingredient Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20150827", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "smart sense allergy and congestion relief d Loratadine, Pseudoephedrine LORATADINE LORATADINE PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONES TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs" ], "storage_and_handling": [ "Other information • each tablet contains: calcium 25 mg • do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • keep in a dry place" ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel COMPARE TO ACTIVE INGREDIENTS IN CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS ACTUAL SIZE non-drowsy** allergy & congestion relief-D PSEUDOEPHEDRINE SULFATE 120 mg, LORATADINE 5 mg EXTENDED RELEASE TABLETS NASAL DECONGESTANT, ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 12 HOUR 12 HOUR RELIEF OF: NASAL & SINUS CONGESTION DUE TO COLDS OR ALLERGIES SNEEZING – RUNNY NOSE – ITCHY, WATERY EYES ITCHY THROAT OR NOSE DUE TO ALLERGIES 10 TABLETS **When taken as directed. See Drug Facts Panel. Smart Sense Allergy & Congestion Relief-D Image 1 Smart Sense Allergy & Congestion Relief-D Image 2" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose" ], "set_id": "055ab06b-297e-41fa-ae82-d35667665721", "id": "eac3922f-c494-4da5-92cf-f2f5a196e968", "active_ingredient": [ "Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20140924", "purpose": [ "Active ingredients (in each tablet) Purpose Chlorpheniramine maleate 4 mg Antihistamine Dextromethorphan hydrobromide 30 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury." ], "when_using": [ "When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? Call 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time, Monday through Friday" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) protect from excessive moisture" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold" ], "set_id": "055b29f1-7e07-4787-9342-ab5629905e4a", "id": "97d99cb7-94b5-48c7-bbf5-4d8da9ad3645", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purpose Chlorpheniramine maleate 4 mg Antihistamine Dextromethorphan hydrobromide 30 mg Cough suppressant" ], "inactive_ingredient": [ "Inactive ingredients acacia, calcium sulfate, carnauba wax, croscarmellose sodium, D&C red No. 27 aluminum lake, FD&C yellow No. 6 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical ink, povidone, sodium benzoate, sugar, talc, titanium dioxide, white wax" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury." ], "spl_product_data_elements": [ "Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine Chlorpheniramine maleate and Dextromethorphan hydrobromide Chlorpheniramine maleate Chlorpheniramine Dextromethorphan hydrobromide Dextromethorphan acacia calcium sulfate carnauba wax croscarmellose sodium D&C red no. 27 FD&C yellow no. 6 aluminum oxide lactose magnesium stearate cellulose, microcrystalline povidones sodium benzoate sucrose talc titanium dioxide white wax CC" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not exceed recommended dose adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours children under 12 years of age: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by MSD Consumer Care, Inc. PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg Antihistamine
Dextromethorphan hydrobromide 30 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 16 Tablet Carton NDC 11523-3601-1 Coricidin ® HBP Decongestant-free COLD RELIEF for people with HIGH BLOOD PRESSURE Cough Suppressant, Antihistamine COUGH & COLD Relieves: Cough Runny Nose Sneezing 16 TABLETS American Heart Association Health Information Enclosed PRINCIPAL DISPLAY PANEL - 16 Tablet Carton" ], "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg Antihistamine
Dextromethorphan hydrobromide 30 mg Cough suppressant
" ] }, { "effective_time": "20130611", "inactive_ingredient": [ "sodium chloride, collagen, glucose, magnesium stearate, aloe extract, opuntia ficus-indica extract, mentha aryensis extract, centella asiatica extract, sophora flavescens aiton extract, angelica acutiloba extract" ], "purpose": [ "- relives the following symtoms yeast infection, vaginal itching and irritaiton, vaginal dryness and odor, menstrual cramps, urinary incontinence, vaginal thghtness" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "• Do not use during pregnant, breast-feeding, or menstrual cycle • Keep this product out of reach of children under 3 years old" ], "spl_product_data_elements": [ "Jilgyungyi ALLANTOIN ALLANTOIN ALLANTOIN SODIUM CHLORIDE COLLAGENASE CLOSTRIDIUM HISTOLYTICUM DEXTROSE MAGNESIUM STEARATE ALOE OPUNTIA FICUS-INDICA MENTHA ARVENSIS FLOWER OIL CENTELLA ASIATICA SOPHORA FLAVESCENS ROOT ANGELICA ACUTILOBA ROOT OIL tablet 3;hp;x white" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "for vaginal use only" ], "package_label_principal_display_panel": [ "package insert" ], "indications_and_usage": [ "This product is to be used in the vagina. Use it at bedtime, or during the day without dynamic activities. Insert the pills into your vagina with first two knuckles of your finger. During the 20 to 30 minutes the pills are melted and they are effective in improving vaginal health" ], "set_id": "0579fcc7-e0c8-4958-8ab4-1ac8e8f7d88f", "id": "62bbe3ca-4f5c-4dab-a559-00cdbd1c0365", "active_ingredient": [ "allantoin" ] }, { "effective_time": "20120109", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone, stearic acid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "spl_product_data_elements": [ "GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID WHITE Capsule shaped C;25" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. Directions Do not exceed 6 doses in 24 hours. Take with a full glass of water. Adults and children 12 years of age and over: 1 tablet, every4 hours Children 6 years to under 12 years: 1/2 tablet, every 4 hours Children under 6 years of age: ask a doctor Other information store between 150°- 30°C (59°- 86°F) do not use if carton is opened Inactive ingredients Croscarmellose sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone, stearic acid Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "stop_use": [ "Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness." ], "package_label_principal_display_panel": [ "Expectorant NDC number 52204-125-99 GUAIFENESIN, 400 mg" ], "set_id": "058f08dc-77de-4968-8558-1b7cf3fb39a3", "id": "058f08dc-77de-4968-8558-1b7cf3fb39a3", "active_ingredient": [ "Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant" ] }, { "effective_time": "20141023", "inactive_ingredient": [ "Water, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica Seed Oil, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter,Propanediol, Algae Extract, Beta Vulgaris (Beet)Root Extract, Chlorella Pyrenoidosa Extract, Dictyopteris Membranacea Extract, Chondrus Crispus Extract, Enteromorpha Compressa Extract, Laminaria Digitata Extract, Macrocystis Pyrifera Extract, Pancratium Maritimum Extract, Spirulina Maxima Extract, Ulva Lactuca Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Alumina, Calcium Ascorbate, Caesalpinia Spinosa Gum, Hydrolyzed Corn Starch, Jojoba Esters, Lactic Acid, Magnesium Stearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Magnesium Stearate, Oryza Sativa (Rice) Starch, p-Anisic Acid, Silica, Sodium Chloride,Sodium Hyaluronate, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Bismuth Oxychloride, Iron Oxides, Mica. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba Even Advanced Mineral CC Cream Fair to Light SPF15 Zinc Oxide, Titanium Dioxide STARCH, CORN MAGNESIUM STEARATE STARCH, RICE SILICON DIOXIDE HYALURONATE SODIUM BISMUTH OXYCHLORIDE SEAWEED ULVA COMPRESSA LAMINARIA DIGITATA JOJOBA OIL, RANDOMIZED PROPANEDIOL BETA VULGARIS CHLORELLA PYRENOIDOSA CHONDRUS CRISPUS CARRAGEENAN NARCISSUS TAZETTA BULB SPIRULINA MAXIMA ORANGE OIL SOYBEAN OIL CALCIUM ASCORBATE CAESALPINIA SPINOSA RESIN LACTIC ACID ANISE FERRIC OXIDE RED MICA ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF ISOAMYL LAURATE COCONUT ALKANES GLYCERIN POLYGLYCERYL-3 RICINOLEATE CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL WATER SHEA BUTTER BRASSICA RAPA SUBSP. OLEIFERA OIL ALUMINUM OXIDE COCO-CAPRYLATE/CAPRATE MAGNESIUM SULFATE SODIUM CHLORIDE SORBITAN SESQUIOLEATE STEARIC ACID ECHINACEA PURPUREA ROOT POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE POLYGONUM AVICULARE TOP ULVA LACTUCA DICTYOPTERIS POLYPODIOIDES MACROCYSTIS PYRIFERA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Cream.For sunscreen use apply liberallyafter cleansing and 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating" ], "package_label_principal_display_panel": [ "tube label carton label" ], "indications_and_usage": [ "Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "0608ed7f-47f7-4c19-e054-00144ff88e88", "id": "0608ed7f-47f8-4c19-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Zinc Oxide 4.0% Titanium Dioxide 3.5%" ] }, { "effective_time": "20141024", "inactive_ingredient": [ "Water, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica Seed Oil, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter,Propanediol, Algae Extract, Beta Vulgaris (Beet)Root Extract, Chlorella Pyrenoidosa Extract, Dictyopteris Membranacea Extract, Chondrus Crispus Extract, Enteromorpha Compressa Extract, Laminaria Digitata Extract, Macrocystis Pyrifera Extract, Pancratium Maritimum Extract, Spirulina Maxima Extract, Ulva Lactuca Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Alumina, Calcium Ascorbate, Caesalpinia Spinosa Gum, Hydrolyzed Corn Starch, Jojoba Esters, Lactic Acid, Magnesium Stearate, Coco-Caprylate/Caprate, Magnesium Sulfate, Magnesium Stearate, Oryza Sativa (Rice) Starch, p-Anisic Acid, Silica, Sodium Chloride,Sodium Hyaluronate, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Bismuth Oxychloride, Iron Oxides, Mica. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba Even Advanced Mineral CC Cream Light to Medium SPF15 Zinc Oxide, Titanium Dioxide STARCH, CORN MAGNESIUM STEARATE STARCH, RICE SILICON DIOXIDE HYALURONATE SODIUM BISMUTH OXYCHLORIDE SEAWEED ULVA COMPRESSA LAMINARIA DIGITATA JOJOBA OIL, RANDOMIZED PROPANEDIOL BETA VULGARIS CHLORELLA PYRENOIDOSA CHONDRUS CRISPUS CARRAGEENAN NARCISSUS TAZETTA BULB SPIRULINA MAXIMA ORANGE OIL SOYBEAN OIL CALCIUM ASCORBATE CAESALPINIA SPINOSA RESIN LACTIC ACID ANISE FERRIC OXIDE RED MICA ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF ISOAMYL LAURATE COCONUT ALKANES GLYCERIN POLYGLYCERYL-3 RICINOLEATE CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL WATER SHEA BUTTER BRASSICA RAPA SUBSP. OLEIFERA OIL ALUMINUM OXIDE COCO-CAPRYLATE/CAPRATE MAGNESIUM SULFATE SODIUM CHLORIDE SORBITAN SESQUIOLEATE STEARIC ACID ECHINACEA PURPUREA ROOT POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE POLYGONUM AVICULARE TOP ULVA LACTUCA DICTYOPTERIS POLYPODIOIDES MACROCYSTIS PYRIFERA TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Cream.For sunscreen use apply liberallyafter cleansing and 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen when swimming or sweating" ], "package_label_principal_display_panel": [ "tube label carton label" ], "indications_and_usage": [ "Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "06338be6-bfdf-3c44-e054-00144ff8d46c", "id": "06338be6-bfe0-3c44-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Zinc Oxide 4.0% Titanium Dioxide 3.5%" ] }, { "effective_time": "20100823", "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid." ], "keep_out_of_reach_of_children": [ "CHILDREN Keep away from children Avoid contact with eyes May be harmful if swallowed or inhaled" ], "purpose": [ "PURPOSE Active Ingredient Purpose Salicylic acid (2%) Acne medication ______________________________________ Uses n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal." ], "warnings": [ "WARNINGS Warnings n For external use only n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. n Keep away from children n Avoid contact with eyes n May be harmful if swallowed or inhaled" ], "when_using": [ "WHEN USING For external use only Avoid contact with eyes May be harmful if swallowed or inhaled If symptoms last for more than 7 days or clear up and recur within a few days. If the conditions do not improve. Store at 40 to 120 degrees F." ], "spl_product_data_elements": [ "Acneclir SALICYLIC ACID dimethyl sulfoxide ascorbic acid dipropylene glycol water sorbic acid magnesium stearate stearic acid SALICYLIC ACID SALICYLIC ACID" ], "ask_doctor": [ "ASK DOCTOR Ask a physician n If symptoms last for more than 7 days or clear up and recur within a few days. n If the conditions do not improve. n Before use on children under 2 years. n Before use if you are allergic to any ingredients listed on this label." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Uses n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal. ______________________________________ Directions n Clean the skin thoroughly before applying this product. n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. n Each morning, cover the entire affected area with a thin layer of this product. n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product." ], "stop_use": [ "STOP USE n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time." ], "do_not_use": [ "DO NOT USE n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. n Keep away from children n Avoid contact with eyes n May be harmful if swallowed or inhaled" ], "package_label_principal_display_panel": [ "Image of product Image of product Image of product" ], "indications_and_usage": [ "USE Uses n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal. ______________________________________ Directions n Clean the skin thoroughly before applying this product. n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. n Each morning, cover the entire affected area with a thin layer of this product (ACNE22). n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product." ], "set_id": "06667c3a-7513-44b3-8cd0-268c14436ae7", "id": "607f1e90-14fe-4774-8b3d-e2276e92604c", "active_ingredient": [ "DRUG FACTS Drug Facts Active Ingredient Purpose Salicylic acid (2%) Acne medication ______________________________________ Uses n Acne medication lotion. For the treatment of acne. Clears up most acne blemishes and allows skin to heal. ______________________________________ Warnings n For external use only n When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. n Keep away from children n Avoid contact with eyes n May be harmful if swallowed or inhaled ______________________________________ Ask a physician n If symptoms last for more than 7 days or clear up and recur within a few days. n If the conditions do not improve. n Before use on children under 2 years. n Before use if you are allergic to any ingredients listed on this label. ______________________________________ Directions n Clean the skin thoroughly before applying this product. n Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. n Each morning, cover the entire affected area with a thin layer of this product. n Apply this product by rubbing it in. If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product. ______________________________________ Other information Store at 40 to 100 degrees F. Net contents: 3 mL. This product contains no alcohol; no animal products. ______________________________________ Inactive ingredients Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. ______________________________________ Questions and Side effects Use of this product results in no known side effects when used according to directions. Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750; Tel. 580-746-2430 Email address: hp@valliant.net", "ACTIVE INGREDIENTS Active Ingredient Purpose Salicylic acid (2%) Acne medication" ] }, { "effective_time": "20130412", "spl_unclassified_section_table": [ "
Serving Size: 1 Tablet Amount per Tablet % Daily Value
Iron (as ferrous sulfate) 65 mg 360 %
" ], "inactive_ingredient": [ "Inactive Ingredients Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide" ], "purpose": [ "Purpose Iron Supplement" ], "keep_out_of_reach_of_children": [ "DRUG INTERACTION PRECAUTION Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other." ], "warnings": [ "WARNING: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. WARNINGS: Do not exceed recommended dosage. As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product." ], "questions": [ "Questions or Comments DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc." ], "spl_product_data_elements": [ "FERROUS SULFATE IRON SUPPLEMENT FERROUS SULFATE FERROUS CATION CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture. Each tablet contains:" ], "spl_unclassified_section": [ "Supplement Facts[/S] Serving Size: 1 Tablet Amount per Tablet % Daily Value Iron (as ferrous sulfate) 65 mg 360 %" ], "package_label_principal_display_panel": [ "ETODOLAC CAPSULE Label Image" ], "indications_and_usage": [ "SUGGESTED USE One (1) tablet daily, preferably after meals or as directed by the doctor. As directed by the doctor. Adults: Children:" ], "set_id": "067fffa3-ace4-4790-afc2-29ef5e75657f", "id": "1740752d-7e34-4f90-85d1-8aeb55eb87bd", "active_ingredient": [ "Active Ingredient U.S. RDA* EACH TABLET CONTAINS: % Elemental Iron 65 mg 360 (Equivalent to 325 mg of Ferrous Sulfate) * U.S. Recommended Daily Allowance" ] }, { "effective_time": "20150803", "purpose": [ "Purpose Stool softener Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "dosage_forms_and_strengths": [ "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor" ], "dosage_forms_and_strengths_table": [ "
age starting dosage maximum dosage
adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
" ], "indications_and_usage": [ "Drug Facts" ], "set_id": "07653724-015c-4403-a606-b9b8e4582b6d", "id": "b172d975-7f46-41f6-a182-b3938bc88952", "active_ingredient": [ "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients dicalcium phosphate,D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, lecithin, magnesium stearate ,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide ©2012, Purdue Products L.P. Manufactured for: Purdue Products L.P. Stamford, CT 06901-3431 By: Purdue Pharma 575 Granite Court Pickering, ON L1W 3W8, Canada 302887-0A" ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "Senokot-S standardized senna concentrate and docusate sodium SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS D&C YELLOW NO. 10 FD&C YELLOW NO. 6 EGG PHOSPHOLIPIDS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL STARCH, CORN SODIUM BENZOATE TALC TITANIUM DIOXIDE P" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks" ], "warnings_and_cautions": [ "" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "how_supplied": [ "Other information each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)" ], "do_not_use": [ "Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Image of Label Image of Label" ] }, { "effective_time": "20151223", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Dicalcium Phosphate, FD&C Yellow #5,Lake, FD&C Yellow #6 Lake, Hydroxypropylmethylcellulose, Magensium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic cid and Titanium Dioxide." ], "purpose": [ "Purpose" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poision Control Center right away." ], "warnings": [ "Warnings Do not use for longer than one week, when abdominal pain, nausea or vomiting are present." ], "spl_product_data_elements": [ "Senna Plus Senna Plus CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM ALUMINUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CPC490" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Take preferably at bedtime or as directed by a doctor, if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable age starting dose maximum dose adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding, you fail to have a bowel movement after use of this product, may indicate a serious condition. You may report side effects to FDA at 1-800-FDA-1088." ], "storage_and_handling": [ "Store at controlled room temperature 20°C to 25°C (68°-77°F), excursions permitted to 15°C to 30°C (598°-86°F). Mfg by Contract Pharmacal Corp Hauppauge, NY 11788 USA www.CPCHealth.com" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Plus Carton Label" ], "indications_and_usage": [ "Uses For the short term relief of constipation, produce bowel movement in 6 to 12 hours." ], "set_id": "07beb7c7-af12-48a3-ae0f-fce96ce1fca8", "id": "2794d704-947c-195f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks" ], "active_ingredient": [ "Active ingredient Sennosides form Senna Concentrate 8.6mg Sodium Dioctylsulfosuccinate 50 mg" ], "dosage_and_administration_table": [ "
age starting dose maximum dose
adults and children over 12 years 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor
" ] }, { "effective_time": "20150331", "inactive_ingredient": [ "INACTIVE INGREDIENTS Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White Flat Faced Beveled Edge RC17" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DIRECTIONS • place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. • use tablet immediately after opening individual blister." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NON-DROWSY * Well at Walgreens NDC 0363-0527-71 Wal-itin ® WALGREENS PHARMACIST RECOMMENDED ‡ 24 Hour Allergy Relief Fast Dissolving Tablets Loratadine Orally Disintegrating Tablets USP, 10 mg Antihistamine • Relief of runny nose, sneezing, Itchy throat or nose & Itchy, watery eyes • Ages 6 years & older 70 TABLETS INDOOR/OUTDOOR ALLERGIES 24 HOUR Compare to Claritin ® RediTabs ® active ingredient ‡‡ ORALLY DISINTEGRATING TABLETS * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 5115100/ORG0315-F This is the 10 count blister carton label for Walgreens Loratadine ODT." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "07e54d8e-e129-4883-b688-a3510597b503", "id": "02b3be0a-9cf0-432e-a486-202d011be12b", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20121031", "inactive_ingredient": [ "INACTIVE INGREDIENTS Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White Flat Faced Beveled Edge RC17 Loratadine Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White Flat Faced Beveled Edge RC17" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. keep in a dry place. use tablet immediately after opening individual blister." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL GOOD NEIGHBOR PHARMACY ® Compare to active ingredient in Alavert *** NDC 24385-0540-53 Non-Drowsy * Allergy Relief loratadine orally disintegrating tablets, 10 mg antihistamine no water needed melts in your mouth Indoor & Outdoor Allergies For Adults and Children six years and older! For 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat 12 orally disintegrating tablets * When taken as directed. See Drug Facts Panel. Distributed By: AmerisourceBergen 5087125/R0611 GOOD NEIGHBOR PHARMACY ® Compare to active ingredient in Claritin ® Reditabs ®** NDC 24385-0161-52 Non-Drowsy * 24 HOUR Allergy Relief loratadine orally disintegrating tablets, 10 mg antihistamine no water needed melts in your mouth Indoor & Outdoor Allergies Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose For Kids 6 yrs and older! 10 orally disintegrating tablets * When taken as directed. See Drug Facts Panel. Distributed By: AmerisourceBergen 5087123/R0611 This is the blister carton label for 12 count Loratadine ODT for Good Neighbor Pharmacy. This is the 10 count blister carton label for Good Neighbor Pharmacy Loratadine ODT, 10 mg (Claritin like - for kids)." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "08bef2a7-c15f-4930-97c1-9d988e7b5181", "id": "ba155366-479c-4de8-b02f-cc287131a60d", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20140814", "purpose": [ "Active Ingredients Purpose Arnica Montana 30C HPUS To reduce jet lag Bellis Perennis 30C HPUS Chamomilla 30C HPUS Ipecacuanha 30C HPUS Lycopodium 30C HPUS The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other Information store under 86°F (30°C) No drug interactions Non-drowsy" ], "indications_and_usage": [ "Uses For the relief of tiredness and jet lag associated with flying" ], "set_id": "08c4538a-836e-4d14-9143-245a77346b23", "id": "0055b112-9820-4fad-b7e0-58264b97fb60", "active_ingredient": [ "Active Ingredients Purpose Arnica Montana 30C HPUS To reduce jet lag Bellis Perennis 30C HPUS Chamomilla 30C HPUS Ipecacuanha 30C HPUS Lycopodium 30C HPUS The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States." ], "dosage_and_administration_table": [ "
Age Dose
Adults and Children 2 years and over Chew one tablet on each take-off, one about every two hours, and one after landing. However, intervals of up to four hours between tablets are acceptable if sleeping. Best taken separately from meals.
Under 2 years Ask a doctor.
" ], "inactive_ingredient": [ "Inactive ingredients Dextrose and separating agents magnesium stearate and silicon dioxide." ], "warnings": [ "Warnings Do not use if the blister pack is broken. Ask a doctor before use in children under 2 years of age. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "NO-JET-LAG Arnica Montana, Bellis Perennis, Matricaria Recutita, Ipecac, and Lycopodium Clavatum Spore Arnica Montana Arnica Montana Bellis Perennis Bellis Perennis Matricaria Recutita Matricaria Recutita Ipecac Ipecac Lycopodium Clavatum Spore Lycopodium Clavatum Spore Dextrose silicon dioxide Magnesium stearate ML" ], "ask_doctor": [ "Ask a doctor before use in children under 2 years of age." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Age Dose Adults and Children 2 years and over Chew one tablet on each take-off, one about every two hours, and one after landing. However, intervals of up to four hours between tablets are acceptable if sleeping. Best taken separately from meals. Under 2 years Ask a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Distributed to retailers by L.C. Industries, Inc Elk Grove Village, IL 60007" ], "stop_use": [ "Stop use and ask a doctor if symptoms persist for more than 3 days or worsen." ], "do_not_use": [ "Do not use if the blister pack is broken." ], "active_ingredient_table": [ "
Active Ingredients Purpose
Arnica Montana 30C HPUS To reduce jet lag
Bellis Perennis 30C HPUS
Chamomilla 30C HPUS
Ipecacuanha 30C HPUS
Lycopodium 30C HPUS
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 32 Tablet Carton Made in New Zealand The Perfect Travel Companion NDC 59672-0130-4 NO-JET-LAG ® Homeopathic Jet Lag Prevention Safe • Natural • Effective • No Side Effects or Drug Interactions Available in Australia, Canada, Hong Kong, New Zealand, Singapore, South Africa, UAE & USA NET 32 TABLETS: SUFFICIENT FOR 50 HOURS OF FLYING Principal Display Panel - 32 Tablet Carton" ], "purpose_table": [ "
Active Ingredients Purpose
Arnica Montana 30C HPUS To reduce jet lag
Bellis Perennis 30C HPUS
Chamomilla 30C HPUS
Ipecacuanha 30C HPUS
Lycopodium 30C HPUS
" ] }, { "effective_time": "20130320", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Allergy alert: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Stomach bleeding warning: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? (800) 616-2471" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;291" ], "ask_doctor": [ "Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "storage_and_handling": [ "Other information store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package" ], "do_not_use": [ "Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "IBUPROFEN TABLET, FILM COATED Label Image" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "090fccce-3bcf-4541-afce-8577a9838b23", "id": "a4a288bd-5325-40f0-a03f-abb9b68b609c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120531", "inactive_ingredient": [ "Inactive Ingredients Sucrose Lactose Microcrystalline cellulose Clear coating Stearic Acid Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Sucralose" ], "purpose": [ "Homeopathic Purpose Kali Sulphuricum 6x Chirping, Crackling, Humming Salicylicum Acidum 6x,12x Roaring, Ringing, Buzzing Silicea 6x Pain, Discomfort Calcarea Sulphuricum 6x Inner Ear Problems Chininum Sulphuricum 12x Hardness of Hearing Thiosinaminum 6x,12x Eardrum Problems" ], "keep_out_of_reach_of_children": [ "Keep this and all medicines out of reach of children." ], "warnings": [ "Warnings - Consult with your doctor prior to use if you are currently taking blood thinning medications or if you are a pregnant or nursing. - Initial worsening of symptoms may occur. - If symptoms persist or worsen, consult your doctor." ], "questions": [ "TRP Company 1575 Delucchi Lane #115 Reno, NV 89502 888-969-6855 www.trpcompany.com" ], "spl_product_data_elements": [ "Ring Relief Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea Potassium Sulfate Potassium Cation Salicylic Acid Salicylic Acid Silicon Dioxide Silicon Dioxide Calcium Sulfate Anhydrous Calcium Cation Quinine Sulfate Quinine Allylthiourea Allylthiourea Citrus Bioflavonoids Citrus Bioflavonoids Ginkgo Ginkgo Thiamine Thiamine Riboflavin Riboflavin Niacinamide Niacinamide Pantothenic Acid Pantothenic Acid Pyridoxine Pyridoxine Cyanocobalamin Cyanocobalamin Biotin Biotin Folic Acid Folic Acid Inositol Inositol Zinc Picolinate Zinc Picolinate Ascorbic Acid Ascorbic Acid Sucrose Lactose Cellulose, Microcrystalline Stearic Acid Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Sucralose Tablet None" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Take 1 caplet, morning and evening, 5 minutes before or 20 minutes after a meal. Let the homeopathic external shell dissolve in your mouth until the sweetness is gone (approx. 20-40 seconds), then swallow the remaining vitamin enriched core with water. For faster results take 1 caplet 3 times per day. For best results, use for at least 6 months. After desired results are achieved, reduce dosing to 1 caplet 2 times per day." ], "stop_use": [ "Stop Use and See A Doctor If You experience ear pain or prolonged worsening of symptoms." ], "spl_unclassified_section": [ "Other Information Tinnitus may be a symptom of a more serious health condition and your doctor should be consulted for proper diagnosis. Over the counter drugs like aspirin or drugs such as caffeine and tobacco can aggravate tinnitus. For maximum results, and especially if earwax build up is an issue, use caplets with Ring Relief Ear Drops." ], "do_not_use": [ "Do not use If tamper evident seal is broken." ], "active_ingredient_table": [ "
Kali Sulphuricum 6x
Salicylicum Acidum 6x,12x
Silicea 6x
Calcarea Sulphuricum 6x
Chininum Sulphuricum 12x
Thiosinaminum 6x,12x
Citrus Bioflavonoids 300 mg
Ginkgo 30 mg
Thiamine 0.5 mg
Riboflavin 0.5 mg
Niacinamide 10 mg
Pantothenic Acid 2.5 mg
Pyridoxine 0.5 mg
Cyanocobalamin 200 mcg
Biotin 100 mcg
Folic Acid 200 mcg
Inositol 37.5 mg
Zinc Picolinate 7.5 mg
Ascorbic Acid 150 mg
" ], "package_label_principal_display_panel": [ "Bottle image Box image" ], "indications_and_usage": [ "Uses According to homeopathic indications these ingredients provide temporary relief from symptoms of Tinnitus such as: - Ringing - Buzzing - Noises in ears - Pain and Discomfort" ], "set_id": "0a38f93c-cf61-48f0-be17-909c7a6485c6", "id": "747751c1-49c6-499c-9f28-93806138de11", "purpose_table": [ "
Kali Sulphuricum 6x Chirping, Crackling, Humming
Salicylicum Acidum 6x,12x Roaring, Ringing, Buzzing
Silicea 6x Pain, Discomfort
Calcarea Sulphuricum 6x Inner Ear Problems
Chininum Sulphuricum 12x Hardness of Hearing
Thiosinaminum 6x,12x Eardrum Problems
" ], "inactive_ingredient_table": [ "
Sucrose
Lactose
Microcrystalline cellulose
Clear coating
Stearic Acid
Croscarmellose Sodium
Silicon Dioxide
Magnesium Stearate
Sucralose
" ], "active_ingredient": [ "Active Ingredients Kali Sulphuricum 6x Salicylicum Acidum 6x,12x Silicea 6x Calcarea Sulphuricum 6x Chininum Sulphuricum 12x Thiosinaminum 6x,12x Citrus Bioflavonoids 300 mg Ginkgo 30 mg Thiamine 0.5 mg Riboflavin 0.5 mg Niacinamide 10 mg Pantothenic Acid 2.5 mg Pyridoxine 0.5 mg Cyanocobalamin 200 mcg Biotin 100 mcg Folic Acid 200 mcg Inositol 37.5 mg Zinc Picolinate 7.5 mg Ascorbic Acid 150 mg" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive ingredients carnauba wax, cellulose, crospovidone, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica gel, sodium starch glycolate, starch, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain reliever Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if glaucoma liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis high blood pressure diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability occurs, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage excitability occurs, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Maximum Strength Allergy Sinus Acetaminophen, Chlorpheniramine maleate, Pseudoephedrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX CROSPOVIDONE FD&C YELLOW NO. 6 MAGNESIUM STEARATE TITANIUM DIOXIDE 44;342" ], "ask_doctor": [ "Ask a doctor before use if glaucoma liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis high blood pressure diabetes" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over: 2 caplets every 4 to 6 hours. Do not take more than 8 caplets in 24 hours. children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number for better identification keep caplets in carton until used" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal display panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDEDǂ NDC 0363-0342-08 MAXIMUM STRENGTH Allergy Sinus-D D Allergy & Sinus Acetaminophen 500 mg / Pain Reliever Pseudoephedrine HCl 30 mg / Nasal Decongestant Chlorpheniramine Maleate 2 mg / Antihistamine • Relief of runny nose, sneezing, nasal congestion, sinus pain/pressure & itchy, watery eyes 24 CAPLETS ǂWalgreens Pharmacist Survey Study, November 2010. 50844 ORG101115712 ITEM 510072 ORG1112-F DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Walgreens 44-342 Walgreens 44-342" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sinus pain headache sinus pressure runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0a4ace8c-562e-43af-9efb-d323ee4c22ab", "id": "8ea5f196-8c1b-43ba-98c0-b23e18ee3ebc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Chlorpheniramine maleate 2 mg Pseudoephedrine HCl 30 mg" ] }, { "effective_time": "20121114", "inactive_ingredient": [ "Inactive Ingredients Lactose, magnesium stearate (vegetable source)." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema. Do not use if outer package seal is broken. Stop use and consult a doctor if symptoms do not improve within 3 days, worsen or are accompanied by a persistent fever over 101˚F." ], "questions": [ "Questions? Call toll free or email us at: 1-888-60-B-WELL (1-888-602-9355) info@homeostasislabs.com" ], "spl_product_data_elements": [ "Childrens Cough and Cold RELIEF ARSENIC TRIOXIDE - FERROSOFERRIC PHOSPHATE - PULSATILLA VULGARIS - SILICON DIOXIDE - DROSERA ROTUNDIFOLIA - SPONGIA OFFICINALIS SKELETON, ROASTED - SAMBUCUS NIGRA FLOWERING TOP - ARSENIC TRIOXIDE ARSENIC CATION (3+) FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE PULSATILLA VULGARIS PULSATILLA VULGARIS SILICON DIOXIDE COLLOIDAL SILICON DIOXIDE DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA SPONGIA OFFICINALIS SKELETON, ROASTED SPONGIA OFFICINALIS SKELETON, ROASTED SAMBUCUS NIGRA FLOWERING TOP SAMBUCUS NIGRA FLOWERING TOP LACTOSE MAGNESIUM STEARATE Heart H" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Give child one tablet and allow to chew or dissolve in the mouth. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child. Repeat every 4 hours as needed." ], "pregnancy_or_breast_feeding": [ "" ], "spl_unclassified_section": [ "Other information Safe to take with all other medications. Store at 68-77°F (20-25°C) and keep out of direct sunlight. Avoid humid or damp storage conditions. Close well when not in use." ], "do_not_use": [ "" ], "active_ingredient_table": [ "
Active Ingredients Purpose
Arsenicum album 6C, HPUS Relieves runny nose & restlessness
Drosera rotundifolia 6C, HPUS Relieves night timecough
Ferrum phosphoricum 6C, HPUS Relieves loss of energy
Pulsatilla 6C, HPUS Relieves excessive mucus in nasal passage
Sambucus nigra 6C, HPUS Relieves bronchial cough
Silicea 6C, HPUS Relieves runny nose
Spongia tosta 6C, HPUS Relieves barking cough
" ], "package_label_principal_display_panel": [ "Box image" ], "indications_and_usage": [ "Uses For relief of deep coughs, cold, runny nose and excessive mucus in nasal passage & lungs. Safe for children 2 years and older (if younger than 2 years consult your doctor first)." ], "set_id": "0aadc8d1-4780-43d1-8c00-e3c9fe6b6ae3", "id": "540c397b-a7a0-4337-baf1-79bb2bfd9ed5", "active_ingredient": [ "Active Ingredients Purpose Arsenicum album 6C, HPUS Relieves runny nose & restlessness Drosera rotundifolia 6C, HPUS Relieves night timecough Ferrum phosphoricum 6C, HPUS Relieves loss of energy Pulsatilla 6C, HPUS Relieves excessive mucus in nasal passage Sambucus nigra 6C, HPUS Relieves bronchial cough Silicea 6C, HPUS Relieves runny nose Spongia tosta 6C, HPUS Relieves barking cough \"HPUS\" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth. Statement of Identity: Children's antitussive." ] }, { "effective_time": "20110111", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Purpose: Antihistimine", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warnings Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are: taking any drugs for asthma taking sedatives or tranquilizers", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "When using this product Drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitaility may occur, especially in children", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE DIPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 STARCH, CORN PINK WHITE CPC;835 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: do not give to children under 12 years of age unless directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967", "Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "DIPHEN_PDP", "DIPHEN_PANEL", "ONEPERSONKIT_FRONT", "ONEPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever", "Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes" ], "set_id": "0adedf0d-6c71-4ed9-963f-1fc41c1ae0f6", "id": "22f141f4-f307-4e18-a8ca-275e075f2547", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient (in each tablet) Purpose Diphenhydramine Hydrochloride 25mg............................... Antihistimine", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20151016", "inactive_ingredient": [ "Inactive ingredients hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Allergy alert: Do not sue if you are allergic to famotidine or other acid reducers. Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. if you have kidney disease, except under the advice and supervision of a doctor with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn Stop use and ask a doctor if your heartburn continues or worsens you need to take this product ofr more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "questions": [ "Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday" ], "spl_product_data_elements": [ "Maximum Strength Acid Reducer Famotidine FAMOTIDINE FAMOTIDINE HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE W374" ], "ask_doctor": [ "Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablets with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product ofr more than 14 days" ], "storage_and_handling": [ "Other information read the directions and warnings before use store at 20º-25ºC (68º-77ºF) TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture keep the carton. It contains important information." ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. if you have kidney disease, except under the advice and supervision of a doctor with other acid reducers" ], "package_label_principal_display_panel": [ "Principal display panel SOUND BODY ™ COMPARE TO THE ACTIVE INGREDIENT IN MAXIMUM STRENGTH PEPCID® AC® * Just One Tablet Relieves and Prevents Heartburn Due to Acid Indigestion MAXIMUM STRENGTH Acid Reducer Famotidine USP 20 mg Acid Reducer 20 Tablets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENEED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Pepcid® AC®. 50844 ORG061262209 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Product of India V#733000 ITEM#022762209blbx Sound Body 44-622 Sound Body 44-622" ], "indications_and_usage": [ "Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages" ], "set_id": "0b1c402d-b8ad-4d44-9190-f2d9e8deb79c", "id": "c5fc2b74-ba6c-4c12-950f-f83b1bc001f8", "active_ingredient": [ "Active ingredients (in each tablet) Famotidine USP 20 mg" ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients aspartame, cherry flavor, D&C Red # 27, magnesium stearate, sorbitol" ], "purpose": [ "Purposes Antacid Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If pregnant or breast feeding, ask a health professional before use." ], "warnings": [ "Warnings Do not use more than the recommended dosage or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Ask a doctor before use if you have a magnesium restricted diet kidney disease Do not exceed recommended dosage." ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "Medique Alamag ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION ASPARTAME D&C RED NO. 27 MAGNESIUM STEARATE SORBITOL pink ROUND AZ;278 CHERRY" ], "ask_doctor": [ "Ask a doctor before use if you have a magnesium restricted diet kidney disease Do not exceed recommended dosage." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed do not exceed 16 tablets a day unless directed by a physician Adults and children: (12 years and older) Chew 1 or 2 tablets thoroughly. Use after meals or at bedtime, or as directed by a physician. May also be taken as needed, up to 16 tablets daily. If symptoms persist, contact a physician. Tablets should be chewed or allowed to dissolve slowly in mouth. Children under 12 years: Do not give to children under 12 years of age. Other information phenylketonurics: contains phenylalanine 2.6 mg per tablet each tablet contains 62 mg of magnesium store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "do_not_use": [ "Do not use more than the recommended dosage or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician" ], "package_label_principal_display_panel": [ "103R Medique Alamag Label Collect MediBucks See inside flap for more details Medique® Alamag Antacid Tablets Aluminum Hydroxide/Hidroxide de Aluminio Magnesium Hydroxide/Hidroxide de Magnesio Wild Cherry Flavor Sabor a Cereza Silvestre Great Tasting Chewable Tablets Gran Sabor Tabletas Masticables Pull to Open TiraParaAbrir 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Untarias 103R Medique Alamag Label" ], "indications_and_usage": [ "Uses For the relief of the following symptoms associated with: heartburn sour stomach acid indigestion upset stomach" ], "set_id": "0b233641-dd31-420a-b4a2-005218bd1293", "id": "61c1bd2a-6df5-4926-a1ea-0fb73ec1f006", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each tablet) Dried Aluminum Hydroxide Gel 300 mg Magnesium Hydroxide........150 mg" ] }, { "effective_time": "20100111", "inactive_ingredient": [ "Inactive ingredients Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid, Vanilla Flavor." ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use for children under 12 years of age unless directed by a doctor Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-800-344-7239 or visit us on the web at www.insightpharma.com" ], "spl_product_data_elements": [ "Bonine meclizine hydrochloride meclizine hydrochloride meclizine crospovidone FD&C Red No. 40 Aluminum Oxide Lactose Magnesium Stearate Silicon Dioxide Saccharin Sodium stearic acid Croscarmellose Sodium light pink Bonine;201" ], "ask_doctor": [ "Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749" ], "storage_and_handling": [ "Other information store at room temperature 20°– 25°C (68°–77°F)" ], "do_not_use": [ "Do not use for children under 12 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 8 Tablet Carton BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC Prevents Motion Sickness Chewable Once-A-Day Protection 8 Tablets PRINCIPAL DISPLAY PANEL - 8 Tablet Carton" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness" ], "set_id": "0b4b55cd-063e-4d0e-911c-8e03886e15d3", "id": "82885c3d-4964-44dd-8bb6-fe55afab3ce7", "active_ingredient": [ "Active ingredient (in each tablet) Meclizine HCl 25 mg" ] }, { "effective_time": "20151006", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Carbopol 934p, Di-calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, D&C Red # 27, FD&C Blue # 2, FD&C Red # 40, Hypromellose, Macrogol, Polydextrose, Talc, Titanium Dioxide, Triacetin." ], "package_label_principal_display_panel": [ "ACKAGE LABEL PRINCIPAL DISPLAY PANEL Uralgic label" ], "spl_product_data_elements": [ "Uralgic Methenamine, Sodium Biphosphate, Phenyl Salicylate, Methylene Blue, Hyoscyamine HYOSCYAMINE SULFATE HYOSCYAMINE POLYDEXTROSE TITANIUM DIOXIDE TALC D&C RED NO. 27 TRIACETIN CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 FD&C RED NO. 40 HYPROMELLOSES POLYETHYLENE GLYCOLS CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) METHENAMINE METHENAMINE METHYLENE BLUE METHYLENE BLUE CATION PHENYL SALICYLATE PHENYL SALICYLATE POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM CATION WP;103" ], "description": [ "DESCRIPTION SECTION Each tablet contains: Methenamine, USP ------------------------- 81.6 mg Sodium Biphosphate, USP –------------- 40.8 mg Phenyl Salicylate, USP --------------------- 36.2 mg Methylene Blue, USP ----------------------- 10.8 mg Hyoscyamine Sulfate, USP ---------------- 0.12 mg" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY SECTION HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissues and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8. METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine." ], "set_id": "0b758028-9c9c-50c6-e054-00144ff88e88", "id": "21753fae-69d5-4c23-e054-00144ff88e88", "openfda": {}, "version": "5" }, { "effective_time": "20140415", "inactive_ingredient": [ "Inactive ingredients FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters • If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed • Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • Ask a doctor before use if the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma • Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition • taking any other drug • When using this product take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed • Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • you have difficulty swallowing • it feels like the pill is stuck in your throat • redness or swelling is present in the painful area • any new symptoms appear • If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed •" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES TALC TITANIUM DIOXIDE Light Blue L490" ], "ask_doctor": [ "Ask a doctor before use if the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers • you have asthma •" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose • Adults and children 12 years and older: take 1 tablet every 8 to 12 hours while symptoms last • for the first dose you may take 2 tablets within the first hour • do not exceed 2 tablets in any 8- to 12-hour period • do not exceed 3 tablets in a 24-hour period • Children under 12 years: ask a doctor •" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • you have difficulty swallowing • it feels like the pill is stuck in your throat • redness or swelling is present in the painful area • any new symptoms appear •" ], "storage_and_handling": [ "Other information each tablet contains: sodium 21 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). •" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery •" ], "package_label_principal_display_panel": [ "NAPROXEN SODIUM TABLET Label Image" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever •" ], "set_id": "0bdff07f-9852-4ec7-a1c4-74ba68cce3c3", "id": "cf020deb-1ded-413c-912d-299443a61f6f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition • taking any other drug •" ], "active_ingredient": [ "Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150715", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers. Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "questions": [ "Questions or comments? Call 1-877-932-7948 24 hours a day, 7 days a week" ], "spl_product_data_elements": [ "Heartburn Relief Maximum Strength Ranitidine RANITIDINE HYDROCHLORIDE RANITIDINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE TALC TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS 9R" ], "ask_doctor": [ "Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "storage_and_handling": [ "Other information TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN store at 20º-25ºC (68º-77ºF) avoid excessive heat or humidity this product is sodium and sugar free see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor" ], "package_label_principal_display_panel": [ "Principal display panel equa line ® compare to Zantac 150® active ingredient* NDC 41163-062-08 maximum strength heartburn relief ranitidine tablets USP, 150 mg acid reducer PREVENTS & RELIEVES: HEARTBURN associated with acid indigestion & sour stomach 24 tablets (24 doses) TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Zantac 150®. 50844 ORG031362008 Product of India DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com. Please have package available. Equaline 44-620 Equaline 44-620" ], "indications_and_usage": [ "Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages" ], "set_id": "0beb5185-a7fb-4a69-bd5c-6e52e22f0ef0", "id": "9e0b9ad7-01ab-4d5c-8a1a-7390e0d89b60", "active_ingredient": [ "Active ingredient (in each tablet) Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)" ] }, { "effective_time": "20110225", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Destrose, Magnesium stearate, Microcrystalline cellulose." ], "purpose": [ "For temporary relief from the Scaling, Itching and Redness of Psoriasis." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF THE REACH OF CHILDREN." ], "warnings": [ "WARNINGS: If symptoms persist or worsen, contact a physician. If pregnant or nursing use only under the advice and supervision of a physician. Keep out of the reach of children. Do not use if seal is missing or broken. CAUTION: Use only as directed. Do not give to children under 12. If skin rash appears, discontinue use and consult a physician." ], "questions": [ "Distributed By: The Natural Products Center Westlake, Ohio 44145 440-808-9000 www.naturalproductscenter.com" ], "spl_product_data_elements": [ "VestalCare Spot Free Psoriasis Calcarea silicata, Lithium carbonicum, Natrum muriaticum, Phytolacca decandra, Sarsaparilla, Sulphur iodatum, Thyroidinum, CALCIUM SILICATE CALCIUM CATION LITHIUM CARBONATE LITHIUM CATION SODIUM CHLORIDE SODIUM CATION PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT SARSAPARILLA ROOT SARSAPARILLA ROOT SULFUR IODIDE SULFUR IODIDE DEXTROSE THYROID THYROID CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE diamond;" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: Take 1 tablet under the tongue once per day. Continue this procedure as long as it is beneficial to your condition." ], "package_label_principal_display_panel": [ "VESTALCARE Spot Free Psoriasis Homeopathic Medicine For temporary relief from the Scaling, Itching and Redness of Psoriasis 60 Tablets VestalCare Spot Free Psoriasis" ], "indications_and_usage": [ "For temporary relief from the Scaling, Itching and Redness of Psoriasis." ], "set_id": "0c232b71-02b7-49b6-a46a-fc168e26975f", "id": "cce09d45-8564-4996-b701-c5d282a8873b", "active_ingredient": [ "ACTIVE INGREDIENTS: Calcarea silicata 30X, Lithium carbonicum 30X, Natrum muriaticum 30X, Phytolacca decandra 30X, Sarsaparilla 30X, Sulphur iodatum 30X, Throidinum 30X." ] }, { "effective_time": "20130302", "drug_interactions": [ "Drug Interactions: This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression." ], "abuse": [ "Abuse and Dependence: Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications." ], "precautions": [ "PRECAUTIONS General: Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher-than-expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ). Information for Patients/Caregivers: Do not take Acetaminophen and Codeine Phosphate Tablets, USP if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Acetaminophen and Codeine Phosphate Tablets, USP and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose. Codeine may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Codeine may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. Drug Interactions: This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Drug/Laboratory Test Interactions: Codeine may increase serum amylase levels. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility. Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and Micronucleus test on mouse bone marrow. Pregnancy: Teratogenic Effects: Pregnancy Category C: Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogeneses in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life. Labor and delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown. Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS - General - Ultra-Rapid Metabolizers of Codeine )." ], "description": [ "DESCRIPTION Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................30 mg Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains: Acetaminophen ......................................................................................................300 mg Codeine Phosphate ..................................................................................................60 mg This is an image of the structural formula of Acetaminophen. This is an image of the structural formula of Codeine Phosphate. In addition each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium metabisulfite, sodium starch glycolate and stearic acid." ], "labor_and_delivery": [ "Labor and delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown." ], "general_precautions": [ "General: Acetaminophen and codeine phosphate tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher-than-expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ).", "Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher-than-expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers )." ], "storage_and_handling": [ "Dispense in a tight, light resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "pharmacokinetics": [ "Pharmacokinetics: The behavior on the individual components is described below. Codeine: Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces. At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours. See OVERDOSAGE for toxicity information. Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.", "Codeine: Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces. At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours. See OVERDOSAGE for toxicity information.", "Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information." ], "indications_and_usage": [ "INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain." ], "set_id": "0c681ff1-9279-465a-ac3a-619d4d7b1552", "id": "cec9ac46-ae10-4628-a432-8f9a792c88a1", "teratogenic_effects": [ "Teratogenic Effects: Pregnancy Category C: Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogeneses in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "dosage_and_administration_table": [ "
Single Doses (range) Maximum 24 Hour Dose
Codeine Phosphate 15 mg to 60 mg 360 mg
Acetaminophen 300 mg to 1000 mg 4000 mg
" ], "inactive_ingredient": [ "In addition each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium metabisulfite, sodium starch glycolate and stearic acid." ], "contraindications": [ "CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Acetaminophen and Codeine Phosphate tablets are classified as a Schedule III controlled substance. Abuse and Dependence: Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications." ], "warnings": [ "WARNINGS Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Hypersensitivity/anaphylaxis: There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Acetaminophen and Codeine Phosphate Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Acetaminophen and Codeine Phosphate Tablets, USP for patients with acetaminophen allergy. In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects such as drowsiness, that may further obscure the clinical course of the patients with head injuries. Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Acetaminophen and codeine phosphate tablets contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people." ], "pregnancy": [ "Pregnancy: Teratogenic Effects: Pregnancy Category C: Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogeneses in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no adequate and well-controlled studies in pregnant women. Acetaminophen and codeine phosphate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life." ], "nursing_mothers": [ "Nursing Mothers: Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from acetaminophen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS - General - Ultra-Rapid Metabolizers of Codeine )." ], "spl_product_data_elements": [ "Acetaminophen And Codeine acetaminophen and codeine phosphate CODEINE PHOSPHATE CODEINE ANHYDROUS ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES STARCH, CORN SODIUM METABISULFITE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 2064;V;3" ], "boxed_warning": [ "BOXED WARNING Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Codeine may increase serum amylase levels. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Acetaminophen and Codeine Phosphate tablets are classified as a Schedule III controlled substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is: Single Doses (range) Maximum 24 Hour Dose Codeine Phosphate 15 mg to 60 mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours. The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription. It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects." ], "adverse_reactions": [ "ADVERSE REACTIONS The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis. At higher doses codeine has most of the disadvantages of morphine including respiratory depression." ], "spl_unclassified_section": [ "CIII Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182436 R6/11-R5" ], "laboratory_tests": [ "Laboratory Tests: In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests." ], "how_supplied": [ "HOW SUPPLIED Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed \"2064\" and \"V\" on one side and debossed \"3\" on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed \"2065\" and \"V\" on one side and debossed \"4\" on the reverse side. They are supplied in bottles of 100, 500 and 1000." ], "information_for_patients": [ "Information for Patients/Caregivers: Do not take Acetaminophen and Codeine Phosphate Tablets, USP if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking Acetaminophen and Codeine Phosphate Tablets, USP and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose. Codeine may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Codeine may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-0025-0 Packaged by: A-S Medication Solutions Libertyville, IL 60048 This is an image of the label for 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablets." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. Pharmacokinetics: The behavior on the individual components is described below. Codeine: Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces. At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours. See OVERDOSAGE for toxicity information. Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility. Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and Micronucleus test on mouse bone marrow." ], "nonteratogenic_effects": [ "Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life." ], "overdosage": [ "OVERDOSAGE Following an acute overdosage, toxicity may result from codeine or acetaminophen. Signs and Symptoms: Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur. In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment: A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.", "Signs and Symptoms: Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur. In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.", "Treatment: A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication." ] }, { "effective_time": "20120815", "drug_interactions": [ "INTERACTIONS Drugs which may interact with folate include: First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Nevertheless, caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants. Second-generation anticonvulsants: Information on second-generation anticonvulsants' (including, but not limited to, lamotrigine) effect on folate levels is limited and cannot be ruled out. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Colchicine: Colchicine may decrease folate plasma levels. L-dopa: L-dopa may decrease folate plasma levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folate may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folate and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study." ], "inactive_ingredient": [ "Ingredients: Folate Folates– including reduced folates, are variant forms of Vitamin B 9 , or Folic Acid. , Pyridoxal 5'-phosphate, Methylcobalamin, Citric Acid, TriPotassium Citrate, Di Calcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Titanium Dioxide, FD&C Red #40 Lake, Black Iron Oxide, Talc, Vegetable Oil, and Polysorbate 80." ], "contraindications": [ "CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "precautions": [ "PRECAUTIONS General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency. PATIENT INFORMATION Duleek™-Met NEW is a prescription vitamin/medical food for use only under medical supervision and direction. INTERACTIONS Drugs which may interact with folate include: First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Nevertheless, caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants. Second-generation anticonvulsants: Information on second-generation anticonvulsants' (including, but not limited to, lamotrigine) effect on folate levels is limited and cannot be ruled out. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Colchicine: Colchicine may decrease folate plasma levels. L-dopa: L-dopa may decrease folate plasma levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folate may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folate and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study." ], "warnings": [ "WARNINGS Caution is recommended in patients with a history of bipolar illness. Do not take this product if you are at risk due to MTHFR mutation, or - specifically, are at risk due to Thermolabile MethyleneTetraHydroFolate Reductase (MTHFR), or C677T / MTHFR, mutation. Patients at risk for C1298T / MTHFR should also not take this product." ], "spl_product_data_elements": [ "L-Methyl-B6-B12 Levomefolate Calcium, Pyridoxal 5-Phosphate, and Methylcobalamin LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID PYRIDOXAL 5-PHOSPHATE PYRIDOXAL 5-PHOSPHATE METHYLCOBALAMIN METHYLCOBALAMIN CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE HYPROMELLOSES POLYETHYLENE GLYCOLS TITANIUM DIOXIDE FD&C RED NO. 40 FERROSOFERRIC OXIDE TALC CORN OIL POLYSORBATE 80 S133" ], "description": [ "DESCRIPTION Duleek™-Met NEW is an orally administered prescription vitamin/medical food. Each tablet contains the following Dietary Ingredients: Folate 3 mg Pyridoxal 5' Phosphate 35 mg Methylcobalamin 2 mg" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The recommended dose is one tablet twice daily (B.I.D.) or as directed. Duleek™-Met NEW must be used under medical supervision." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxal 5'-phosphate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin." ], "spl_unclassified_section": [ "Tablets R x Only", "Drugs which may interact with pyridoxal 5'-phosphate: Pyridoxal 5'-phosphate should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxal 5'-phosphate. However, pyridoxal 5'-phosphate may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.", "Drugs which may interact with methylcobalamin: Antibiotics may alter the intestinal microflora and may decrease the absorption of methylcobalamin. Cholestyramine, colchicines or colestipol may decrease the enterohepatic re-absorption of methylcobalamin. Metformin, para-aminosalicylic acid and potassium chloride may decrease the absorption of methylcobalamin. Nitrous oxide can produce a functional methylcobalamin deficiency.", "Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 06/10 SETON PHARMACEUTICALS" ], "general_precautions": [ "General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency." ], "storage_and_handling": [ "STORAGE Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence." ], "how_supplied": [ "HOW SUPPLIED Duleek™-Met NEW is supplied as oval, red tablets with “S133” debossed on one side, dispensed in bottles of 90 tablets or 500 tablets. Product Code (90 Tablets): 13925-144-90 Seton Pharmaceuticals does not represent these product codes to be actual National Drug Codes (NDCs). NDC format codes are product codes adjusted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems. Product Code (500 Tablets): 13925-144-50 STORAGE Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence." ], "information_for_patients": [ "PATIENT INFORMATION Duleek™-Met NEW is a prescription vitamin/medical food for use only under medical supervision and direction." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL: NDC 13925- 144- 90* DuLeek TM - Met NEW Tablets R x Only 90 Tablets SETON PHARMACEUTICALS Container Label" ], "indications_and_usage": [ "INDICATIONS AND USAGE Duleek™-Met NEW is an orally administered prescription vitamin/medical food indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of dietary supplementation." ], "set_id": "0c69a5e1-c607-432e-8166-5979e196ccca", "id": "0c69a5e1-c607-432e-8166-5979e196ccca", "description_table": [ "
Each tablet contains the following Dietary Ingredients:
Folate 3 mg
Pyridoxal 5' Phosphate 35 mg
Methylcobalamin 2 mg
" ] }, { "effective_time": "20130925", "inactive_ingredient": [ "INACTIVE INGREDIENTS colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide" ], "purpose": [ "PURPOSE Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "questions": [ "QUESTIONS Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ranitidine Ranitidine RANITIDINE HYDROCHLORIDE RANITIDINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TALC TITANIUM DIOXIDE OR;606" ], "ask_doctor": [ "Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "storage_and_handling": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL CVS pharmacy™ Compare to the active ingredient in Zantac 75®* Regular Strength ACID REDUCER RANITIDINE TABLETS, USP 75 mg Prevents & relieves heartburn associated with acid indigestion & sour stomach 8 0 TABLETS Distributed by: CVS Pharmacy, Inc. 5104600/0713 cartonlabel80" ], "indications_and_usage": [ "USES relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages" ], "set_id": "0c9ba844-0d5e-4203-88a7-5f9e3a0a671c", "id": "f1bdb38f-d139-442c-ba58-6fb3bcd0a4b8", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)" ] }, { "effective_time": "20111031", "purpose": [ "Purpose Pain reliever Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "indications_and_usage": [ "Uses temporarily relieves these common cold symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages" ], "set_id": "0cb0fb4f-c1c3-472a-a8d9-010d2c06d0ba", "id": "3fb77464-a314-4880-8da2-fec6bb912db3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours swallow whole – do not crush, chew or dissolve
children under 12 years do not use this adult product in children under 12 years of age
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that lasts or is chronic such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM CARNAUBA WAX MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POLYVINYL ALCOHOL POVIDONE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE L402" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that lasts or is chronic such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see Liver warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours swallow whole – do not crush, chew or dissolve children under 12 years do not use this adult product in children under 12 years of age" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel See New Warnings Information Compare to active ingredients in Tylenol® Cold Head Congestion Daytime Caplets Cold Head Congestion Pain Reliever, Cough Suppressant, Nasal Decongestant Contains 3 Medicines: Headache/Sore Throat – Acetaminophen Nasal Congestion – Phenylephrine HCl Coughing – Dextromethorphan HBr Cool Ice® Instant Cooling Sensation Daytime Non-Drowsy NDC 54868-6233-0 Cold Head Congestion Package Label Cold Head Congestion Package Label" ] }, { "effective_time": "20151009", "inactive_ingredient": [ "Inactive ingredients corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "spl_product_data_elements": [ "diphenhydramine Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE 44;329" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) protect from moisture see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel SIMPLY RIGHT ™ Health Care NDC 68196-329-78 diphenhydramine diphenhydramine HCl 25 mg | antihistamine Compare To The Active Ingredient of Benadryl® Allergy Ultratab®* for allergy relief sneezing runny nose itchy, watery eyes itchy throat or nose 600 tablets *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®. 50844 ORG051232978 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Simpy Right 44-329 Simply Right 44-329" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing" ], "set_id": "0cf64eac-7c5a-444c-9e1d-e39246b08dc9", "id": "3490a89b-dbf5-4a35-bbd6-a117239c42a0", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Diphenhydramine HCl 25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age 1 tablet
children under 6 years of age do not use this product in children under 6 years of age
" ] }, { "effective_time": "20120917", "purpose": [ "PURPOSE Anti-diarrheal" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? Call 1800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "indications_and_usage": [ "USE Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "0d94a916-812b-479d-8576-c037db72fa4d", "id": "a475a511-e0ef-4fd3-a87a-f9d1fee81086", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCI USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use If you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are Taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 TRISTEARIN MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN ANHYDROUS LACTOSE 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 ° – 25 ° C (68 ° – 77 ° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "do_not_use": [ "Do not use If you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 55319-554-53 FAMILY wellness ™ COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM ® A-D * Anti-Diarrheal Loperamide HCL Tablets USP, 2 mg Controls the Symptoms of Diarrhea 12 CAPLETS † Each caplet ( † capsule-shaped tablet) contains Loperamide HCl USP, 2 mg DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., 5085259/R0411 This is the 12 count blister carton label for Family Dollar Loperamide HCl tablets USP, 2 mg." ] }, { "effective_time": "20120801", "inactive_ingredient": [ "Inactive Ingredients Lonicerae Flos, Weeping Forsythia Capsule, Fineleaf Schizonepeta Herb, Prepared Soybean, Lophatherum Herb, Great Burdock Achene, Reed Rhizome, Platycodon Root, Radix Glycyrrhizae, Vitamin C, Peppermint Oil. Excipients: Corn Starch, Stearic Acid, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Betadex, Lactose, Maltodextrin, FD&C Yellow No. 6, FD&C Green No. 3" ], "purpose": [ "Uses Temporarily relieve the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies: Fever Itiching of the nose or throat Minor aches and pains Sneezing Muscle aches Headache Runny nose Itchy eyes" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Do Not Use: Pain lasts more than 10 days Fever lasts more than 3 days If pregnant or breast-feeding, ask a health professional before using" ], "spl_product_data_elements": [ "Cold Remedy Soothing Chlorpheniramine Maleate, Acetaminophen CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ACETAMINOPHEN ACETAMINOPHEN LONICERA CONFUSA WHOLE FORSYTHIA SUSPENSA WHOLE SCHIZONEPETA TENUIFOLIA FLOWERING TOP SOYBEAN LOPHATHERUM GRACILE LEAF ARCTIUM LAPPA FRUIT PHRAGMITES AUSTRALIS ROOT PLATYCODON GRANDIFLORUM ROOT GLYCYRRHIZA URALENSIS ASCORBIC ACID PEPPERMINT OIL MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) STEARIC ACID CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MAGNESIUM STEARATE BETADEX LACTOSE MALTODEXTRIN FD&C YELLOW NO. 6 FD&C GREEN NO. 3" ], "ask_doctor": [ "Stop use and doctor if Condition worsens Symptoms persit for more than 7 days Symptoms clear up and occur again within a few days" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older Take 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hours Children ages 6 to 12 years old Take 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hours Children under 6 years of age Consult a doctor" ], "storage_and_handling": [ "Storage Store at 15°C to 30°C (59°F to 86°F) Keep away from heat Store in a dry place" ], "package_label_principal_display_panel": [ "Image image of packaging" ], "indications_and_usage": [ "While taking this product Do not use this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product, may cause excitability, especially in children May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages Use caution when driving a motor vehicle or operating machinery." ], "set_id": "0e0577fd-e7f7-4772-afce-4e935641b528", "id": "b585ed68-598a-4953-a527-fb63ae7d1dfe", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking other medications Have glaucomea A breathing problem such as emphysema or chronic bronchitis Difficulty in urination due to enlargement of the prostate gland" ], "active_ingredient": [ "Active Ingredients Chlorphenamine Maleate 1.05 mg Acetaminophen 105 mg" ] }, { "effective_time": "20140819", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredient s: Lactose, Magnesium stearate" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep this and all medicines out of the reach of children." ], "purpose": [ "PURPOSE Uses: For the temporary relief of minor arthritis pain, joint stiffness." ], "warnings": [ "WARNINGS Warnings: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Arthritis or any of its ingredients exists." ], "spl_product_data_elements": [ "BHI Arthritis ARNICA MONTANA ROOT, BERBERIS VULGARIS ROOT BARK , BRYONIA ALBA ROOT, CAUSTICUM, CITRULLUS COLOCYNTHIS FRUIT PULP, SOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, LEDUM PALUSTRE TWIG, LYCOPODIUM CLAVATUM SPORE, RANUNCULUS BULBOSUS, RHODODENDRON AUREUM LEAF,TOXICODENDRON PUBESCENS LEAF and SULFUR ARNICA MONTANA ROOT ARNICA MONTANA ROOT BERBERIS VULGARIS ROOT BARK BERBERIS VULGARIS ROOT BARK BRYONIA ALBA ROOT BRYONIA ALBA ROOT CAUSTICUM CAUSTICUM CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE RANUNCULUS BULBOSUS RANUNCULUS BULBOSUS RHODODENDRON AUREUM LEAF RHODODENDRON AUREUM LEAF TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SULFUR SULFUR LACTOSE MAGNESIUM STEARATE TABLET BHI;O;M" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Directions: At first sign of symptoms: Adults: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. Standard dosage: Adults: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 18, consult your healthcare provider. Allow tablets to dissolve completely in the mouth, do not swallow ." ], "package_label_principal_display_panel": [ "BHI Arthritis.jpg" ], "indications_and_usage": [ "INDICATIONS AND USAGE Relieves: Arthritis Pain Joint Stiffness" ], "set_id": "0eaf98b4-39bf-4535-89cb-770d75e47e84", "id": "101ee06a-bed2-40cd-a520-7c97f2cbb3cb", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, *Berberis vulgaris 8X, *Bryonia alba 4X, 8X, 12X, 30X, Causticum 8X, *Colocynthis 5X, *Dulcamara 6X, Ferrum phosphoricum 12X, *Ledum palustre 6X, *Lycopodium clavatum 10X, *Ranunculus bulbosus 6X, *Rhododendron chrysanthum 8X, *Rhus toxicodendron 4X, 8X, 12X, 30X, *Sulphur 10X 15.8 mg each. *Natural ingredients" ] }, { "effective_time": "20120926", "inactive_ingredient": [ "INACTIVE INGREDIENTS Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have Liver disease. Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin. Stop use and ask a doctor if the tablet got stuck in your throat pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE Capsule shaped cor116" ], "ask_doctor": [ "Ask a doctor before use if you have Liver disease." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if the tablet got stuck in your throat pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Lasts up to 8 Hours Use only as directed. NDC 21130-760-51 Arthritis Pain Relief Compare to Tylenol ® Arthritis Pain active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For The Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ™ DISTRIBUTED BY SAFEWAY INC. 5089374/R1011 This is the 100 count bottle carton label for Safeway APAP Arthritis." ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "0eb865a6-229e-452d-a6a9-eb213018d192", "id": "0a02ebb4-0d21-4159-b143-54662c512451", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
children under 18 years of age ask a doctor
" ] }, { "effective_time": "20150213", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. Structure Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "0efebe35-3e8d-3895-e054-00144ff88e88", "id": "0effd72e-4693-2bfa-e054-00144ff8d46c", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID PREDNISONE PREDNISONE 5084;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5335-10 Bottles of 100 NDC 0603-5335-21 Bottles of 500 NDC 0603-5335-28 Bottles of 1000 NDC 0603-5335-32 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5336-10 Bottles of 100 NDC 0603-5336-21 Bottles of 500 NDC 0603-5336-28 Bottles of 1000 NDC 0603-5336-32 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5338-21 Bottles of 500 NDC 0603-5338-28 Bottles of 1000 NDC 0603-5338-32 Unit-of-Use (21 Tablets) NDC 0603-5338-15 Unit-of-Use (48 Tablets) NDC 0603-5338-31 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5339-21 Bottles of 500 NDC 0603-5339-28 Bottles of 1000 NDC 0603-5339-32 Unit-of-Use (21 Tablets) NDC 0603-5339-15 Unit-of-Use (48 Tablets) NDC 0603-5339-31 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL 10544-274-21 Label 21ct" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20121003", "inactive_ingredient": [ "INACTIVE INGREDIENTS Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide" ], "purpose": [ "PURPOSE Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Acid Reducer Ranitidine RANITIDINE HYDROCHLORIDE RANITIDINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE 9R" ], "ask_doctor": [ "Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL select brand ® NDC 15127-340-24 Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Prevents & Relieves Heartburn Associated wit Acid Indigestion & Sour Stomach † Compare to the active ingredient of Zantac 150 ® 24 Tablets Distributed by: SELECT BRAND ® DISTRIBUTORS 5093019/0112 sbrani150" ], "indications_and_usage": [ "USES relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages" ], "set_id": "0f140a8c-8736-40bb-8869-61d9b5b985da", "id": "9d228d53-a9ff-4391-8395-77580924fc26", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)" ] }, { "effective_time": "20141001", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, red 27 lake, yellow 10 lake, dextrose, yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. Keep out of reach of children." ], "when_using": [ "When using this product do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. Keep out of reach of children." ], "spl_product_data_elements": [ "Antacid Calcium carbonate STARCH, CORN CROSPOVIDONE D&C RED NO. 27 D&C YELLOW NO. 10 DEXTROSE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN SUCROSE TALC CALCIUM CARBONATE CALCIUM CATION CARBONATE ION bananna, orange, pineapple orange, punch G127 Reddish pink" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew 2-4 tablets as symptoms occur, or as directed by a doctor. Other information do not use if printed seal under cap is torn or missing. store at room temperature." ], "package_label_principal_display_panel": [ "Principal Display Panel Select Brand Antacid Tablets Extra Strength TROPICAL FRUIT Compare to the Active ingredient in TUMS ® EX Naturally and Artificially Flavored 96 CHEWABLE TABLETS SN" ], "indications_and_usage": [ "Uses relieves acid indigestion heartburn" ], "set_id": "0f266bad-42b0-4529-842d-e69e00094d7f", "id": "f8dc6d0f-a563-4b9a-b373-53e490b06e87", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium carbonate 750 mg" ] }, { "effective_time": "20130423", "inactive_ingredient": [ "Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid." ], "purpose": [ "Purpose Stool Softener" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than one week unless directed to do so by a doctor if you are presently taking mineral oil unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition. If pregnant or breast-feeding, ask a doctor before use Keep out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx" ], "spl_product_data_elements": [ "healthy mama MOVE IT ALONG DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS STARCH, CORN SILICON DIOXIDE SODIUM BENZOATE STEARIC ACID Round Biconvex GPI;S1" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor. Children under 12 years of age: Consult a doctor before use." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a doctor before use" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information Each tablet contains: Calcium 40 mg Each tablet contains: Sodium 10 mg Store at room temperature Do not use if imprinted safety seal is broken or missing" ], "do_not_use": [ "Do not use laxative products for longer than one week unless directed to do so by a doctor if you are presently taking mineral oil unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel healthy mama MOVE IT ALONG! STOOL SOFTNER Untitleddd.jpg Untitled.jpg Untitledd.jpg" ], "indications_and_usage": [ "Uses for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "0f31b449-4ad7-4607-a3a2-23b2cbfd8778", "id": "7ccb92e7-2d83-4019-a1f2-2c1e8dbf368d", "active_ingredient": [ "Active ingredient (in each tablet) Docusate Sodium 100 mg" ] }, { "effective_time": "20101208", "inactive_ingredient": [ "INACTIVE INGREDIENT carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "OTC - PURPOSE ain reliever/fever reducer" ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ● hives ● facial swelling ● asthma (wheezing) ● shock ● skin reddening ● rash ● blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing perscription or nonperscription NSAIDs [aspirin, ibuprofen, naproxen, or others] ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed" ], "pregnancy": [ "IF PREGNANT OR BREAST FEEDING ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "when_using": [ "OTC - WHEN USING ● temporarily relieves minor aches and pains due to: ● headache ● toothache ● backache ● menstrual cramps ● the common cold ● muscular aches ● minor pain of arthritis ● temporarily reduces fever", "OTC - WHEN USING take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see WARNINGS ) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist ● if pain or fever does not respond to 1 tablet, 2 tablets may be used ● do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "spl_product_data_elements": [ "IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN CARNAUBA WAX STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE TABLET IP;143" ], "ask_doctor": [ "OTC - ASK DOCTOR stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic", "STOP USE AND ASK DOCTOR IF you experience any of the following signs of stomach bleeding:. ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "openfda": {}, "version": "135", "spl_unclassified_section": [ "KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "OTC - DO NOT USE ● if you have ever had an allergic reaction to any other pain reliever/fever reducer ● right before or after heart surgery" ], "information_for_patients": [ "OTHER INFORMATION ● store at controlled room temperature ● avoid excessive heat above 40(104 ● use by expiration date on package" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 49349-123-02 STRENGTH:200 mg COLOR: orange SHAPE: ROUND SCORE: No score SIZE: 13 mm IMPRINT: IP;143 QTY: 30 MM1 MM2" ], "set_id": "0f6f9f60-f5ae-47dc-9fda-bae44b4a2d8e", "id": "fe0570c8-aba5-4bb6-8fc5-74a341704091", "ask_doctor_or_pharmacist": [ "OTC - ASK DOCTOR/PHARMACIST under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130313", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL FAMILY wellness ™ COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ®† Non-Drowsy * Allergy Relief Loratadine Tablets USP, 10 mg/Antihistamine Indoor & Outdoor Allergies 24-Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose ORIGINAL PRESCRIPTION STRENGTH 24 HOUR 30 TABLETS * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., 5093740/0312 30's bottle carton label" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "0f7520b3-0d9b-435b-bdeb-e3bc2442a667", "id": "a6858dab-fe54-4a85-9321-4ea7d6e022c9", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150420", "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide*, croscarmellose sodium*, magnesium stearate*, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate*, stearic acid." ], "purpose": [ "Purposes Expectorant Cough Suppressant" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do Not Use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask Doctor before use if you have Ask Doctor/Pharmacist before use if you are taking sedatives or tranquilizers When Using this product ■ do not exceed recommended dosage ■ do not use for more than 7 days Stop Use and ask a doctor if ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use" ], "when_using": [ "When Using this product ■ do not exceed recommended dosage ■ do not use for more than 7 days" ], "spl_product_data_elements": [ "Mucus Relief DM Dextromehtorphan HBr / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID AZ345" ], "ask_doctor": [ "Ask Doctor before use if you have" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older : Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age : do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use" ], "stop_use": [ "Stop Use and ask a doctor if ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel W:\\SPL-OTC\\A&Z\\Mucus Relief DM\\LB1099.jpg" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold" ], "set_id": "0f79670a-a8b3-4014-86d9-8457fba7bca6", "id": "93489726-592a-4d2a-a3f0-770b89cf700a", "ask_doctor_or_pharmacist": [ "Ask Doctor/Pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient Guaifenesin 400mg Dextromehtorphan HBr 20mg" ] }, { "effective_time": "20121114", "inactive_ingredient": [ "Inactive Ingredients Lactose, magnesium stearate (vegetable source), stevia leaf extract." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Do not use if outer package seal is broken. Consult a doctor if there is recent, sudden weight gain, as this could be a sign of a serious underlying condition. Do not give to children under 18 years of age." ], "questions": [ "Questions? Call toll free or email us at: 1-888-60-B-WELL (1-888-602-9355) info@homeostasislabs.com" ], "spl_product_data_elements": [ "Weight Loss RELIEF OYSTER SHELL CALCIUM CARBONATE, CRUDE - IRON - GRAPHITE - POTASSIUM CARBONATE - SODIUM CHLORIDE - OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE IRON IRON GRAPHITE GRAPHITE POTASSIUM CARBONATE CARBONATE ION SODIUM CHLORIDE SODIUM CATION LACTOSE MAGNESIUM STEARATE STEVIA REBAUDIUNA LEAF Rounded H" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions (adults 18 years of age and older) Chew two tablets thoroughly every 6 hours (unless sleeping, then take after walking), allowing each to dissolve in the mouth, then swallow." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, consult a health professional before use." ], "spl_unclassified_section": [ "Other information Safe to take with all other medications. Store at 68-77°F (20-25°C) and keep out of direct sunlight. Avoid humid or damp storage conditions. Close well when not in use." ], "do_not_use": [ "" ], "active_ingredient_table": [ "
Active Ingredients Purpose
Calcarea carbonica 30C, HPUS Increases metabolism
Ferrum metallicum 30C, HPUS Reduces obesity and controls cravings
Graphites 30C, HPUS Reduces obesity in adipose tissue
Kali carbonica 30C, HPUS Reduces obesity and relieves stomach pains
Natrum muriaticum 30C, HPUS Reduces obesity caused by water retention
" ], "package_label_principal_display_panel": [ "Box image" ], "indications_and_usage": [ "Uses To decrease appetite, control cravings and to stimulate metabolism. Should be taken in conjunction with a reduced-calorie and low fat diet." ], "set_id": "0f832de0-d851-46cd-8302-a578b24932e9", "id": "e08b6d67-9c24-4eef-93ec-e345e09038ea", "active_ingredient": [ "Active Ingredients Purpose Calcarea carbonica 30C, HPUS Increases metabolism Ferrum metallicum 30C, HPUS Reduces obesity and controls cravings Graphites 30C, HPUS Reduces obesity in adipose tissue Kali carbonica 30C, HPUS Reduces obesity and relieves stomach pains Natrum muriaticum 30C, HPUS Reduces obesity caused by water retention \"HPUS\" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth." ] }, { "effective_time": "20120904", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive ingredients: lactose, microcrystalline cellulose, magnesium stearate, Light Anhydrous Silicic Acid, titanium oxide, Talc, tar colorant, Hypromellose2910, Polyethylene Glycol, Ethanol, Methylene Chloride" ], "purpose": [ "PURPOSE PURPOSE: Pain reliever, Fever Reducer" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS WARNING 1. When those who drink alcohol over three glasses every day regularly with to take this drug or other antipyretic and analgesic, they must consult a doctor or pharmacist. Gastrointestinal bleeding may occur when these people take this drug. 2. Cardiovascular risks: Administering non-steroidal anti-inflammatory drugs (NSAIDs) including this product may lead to severe cardiovascular thrombotic response, myocardial infaction, and stroke. The possibility of abnormal cardiovascular reaction increases in patients with a period. Adverse reactions should be carefully monitored while an adverse reaction occurs. 3. Gastrointestinal risk: Administering NSAIDs including this product may cause severe gastrointestinal adverse reactions that may develop without any warning signs during the administration period. The risk of these adverse reactions increases in old age (elderly people) or in patients who have taken this drug for a long period." ], "spl_product_data_elements": [ "PROBUFEN IBUPROFEN IBUPROFEN IBUPROFEN lactose magnesium stearate Talc Methylene Chloride SSP4" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Direction 1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, psoriatic arthritis: 200-600mg per dosage orally, 3~4 times a day as ibuprofen for adults. Maximum dosage is 3200mg per day. 2. Juvenile rheumatoid arthiritis: 30-40mg per kg of body weight divided into 3~4 portions per day orally. 3. Mild and moderate pain, common cold: 200-400mg per dosage orally, 3~4 times a day for adults. Appropriately increase or reduce dosage by age or symptom. 4. Children should take the unit-dose below, 3~4 times a day orally. The dosage of children weighing less than 30kg should not exceed 500mg per day. It is advisable to avoid administering on an empty stomach. Unit-dose for children: 11 - 14 yrs : 200 - 250 mg 7 - 10 yrs : 150 - 200 mg 3 - 6 yrs : 100 - 150 mg 1 - 2 yrs : 50 - 100 mg" ], "storage_and_handling": [ "STORAGE AND HANDLING SECTION Other informations: Store in a hemetic container. Store between 1C to 30C" ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Image of blister pack" ], "indications_and_usage": [ "INDICATIONS AND USAGE Uses 1. Major effects Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain. 2. This can be used also for the following diseases. Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumatism (tendinitis, tendosynovitis, synovitis)" ], "set_id": "0fabf67c-5046-4272-b49c-17a3a0ba2fc7", "id": "e9ad6a60-d765-4fa6-a155-b7e1e1bfc733", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENT: Ibuprophen 400mg" ] }, { "effective_time": "20150223", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: March 2005" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "spl_product_data_elements": [ "Loratadine Loratadine SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LORATADINE LORATADINE LOR;10;APO" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information safety sealed: do not use if induction seal, with \"Lift N Peel\" tab, under cap is broken or missing store between 2° and 30°C (36° and 86°F) protect from exceesive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal Display Panel Loratadine Tablets, USP 10mg 30 Tablets NDC 10544-455-30 Label" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0fc465dc-f0d8-06dc-e054-00144ff8d46c", "id": "0fc465dc-f0d9-06dc-e054-00144ff8d46c", "inactive_ingredient_table": [ "
Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326
" ], "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20150225", "drug_interactions": [ "Drug Interactions: Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine." ], "geriatric_use": [ "Elderly: Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. The clinical impact of this is unknown." ], "references": [ "REFERENCES Mogadam M, et al. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:72–6. Kaufman DW, editor. Birth defects and drugs during pregnancy. Littleton, MA: Publishing Sciences Group, Inc., 1977: 296–313. Jarnerot G. Fertility, sterility and pregnancy in chronic inflammatory bowel disease. Scand J Gastroenterol 1982;17:1–4. Korelitz B, et al. Desensitization to sulfasalazine in allergic patients with IBD: an important therapeutic modality. Gastroenterology 1982;82:1104. Holdworth CG. Sulphasalazine desensitization. Br Med J 1981;282:110. Taffet SL, Das KM. Desensitization of patients with inflammatory bowel disease to sulfasalazine. Am J Med 1982;73:520–4." ], "precautions": [ "PRECAUTIONS General: Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately. Information for Patients: Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of sulfasalazine at a maintenance dosage. Patients should be instructed to take sulfasalazine in evenly divided doses preferably after meals. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin. Laboratory Tests: Complete blood counts, including differential white cell count and liver function tests, should be performed before starting sulfasalazine and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with sulfasalazine. The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 mcg/mL appear to be associated with an increased incidence of adverse reactions. Drug Interactions: Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine. Drug/Laboratory Test Interactions: Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine. Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine was tested at 84 (496 mg/m 2 ), 168 (991 mg/m 2 ), and 337.5 (1991 mg/m 2 ) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, sulfasalazine was tested at 675 (2025 mg/m 2 ), 1350 (4050 mg/m 2 ), and 2700 (8100 mg/m 2 ) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans. Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m 2 ). Oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug appears to reverse these effects. Pregnancy: Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to sulfasalazine during pregnancy, but the role of sulfasalazine in these defects has not been established. However, oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see Drug Interactions ) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs. A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population. 1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation. 2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population. 3 No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy. Clinical Considerations: Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. Sulfasalazine and its metabolite are also present in human milk. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus. A case of agranulocytosis has been reported in an infant whose mother was taking both sulfasalazine and prednisone throughout pregnancy. Nursing Mothers: Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations ). Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when sulfasalazine is administered to a nursing mother. There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of sulfasalazine in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking sulfasalazine for signs and symptoms of diarrhea and/or bloody stools. Pediatric Use: Safety and effectiveness in pediatric patients below the age of two years have not been established." ], "pharmacodynamics": [ "Pharmacodynamics The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety." ], "description": [ "DESCRIPTION Sulfasalazine Tablets USP, 500 mg for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([ p -(2-Pyridylsulfamoyl)phenyl]azo) salicylic acid. Structural Formula: This is an image of the structural formula for sulfasalazine. Inactive Ingredients: corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc.", "Therapeutic Classification: Anti-inflammatory agent.", "Chemical Designation: 5-([ p -(2-Pyridylsulfamoyl)phenyl]azo) salicylic acid.", "Structural Formula: This is an image of the structural formula for sulfasalazine." ], "general_precautions": [ "General: Sulfasalazine tablets should be given with caution to patients with severe allergy or bronchial asthma. Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Patients with glucose-6 phosphate dehydrogenase deficiency should be observed closely for signs of hemolytic anemia. This reaction is frequently dose related. If toxic or hypersensitivity reactions occur, the drug should be discontinued immediately." ], "storage_and_handling": [ "Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "pharmacokinetics": [ "Pharmacokinetics In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. In the intestine, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. Absorption: Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 mcg/mL) occurring at 6 hours. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. Distribution: Following intravenous injection, the calculated volume of distribution (Vdss) for SSZ was 7.5 ± 1.6 L. SSZ is highly bound to albumin (>99.3%) while SP is only about 70% bound to albumin. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins. Metabolism: As mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Approximately 15% of a dose of SSZ is absorbed as parent and is metabolized to some extent in the liver to the same two species. The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours. The primary route of metabolism of SP is via acetylation to form AcSP. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible. Excretion: Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. The calculated clearance of SSZ following intravenous administration was 1 L/hr. Renal clearance was estimated to account for 37% of total clearance.", "Absorption: Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 mcg/mL) occurring at 6 hours. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%.", "Distribution: Following intravenous injection, the calculated volume of distribution (Vdss) for SSZ was 7.5 ± 1.6 L. SSZ is highly bound to albumin (>99.3%) while SP is only about 70% bound to albumin. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins.", "Metabolism: As mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Approximately 15% of a dose of SSZ is absorbed as parent and is metabolized to some extent in the liver to the same two species. The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours. The primary route of metabolism of SP is via acetylation to form AcSP. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible.", "Excretion: Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. The calculated clearance of SSZ following intravenous administration was 1 L/hr. Renal clearance was estimated to account for 37% of total clearance." ], "indications_and_usage": [ "INDICATIONS AND USAGE Sulfasalazine tablets, USP are indicated: in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and for the prolongation of the remission period between acute attacks of ulcerative colitis." ], "set_id": "0ff320ac-60e1-4b75-e054-00144ff88e88", "id": "0ff320ac-60e2-4b75-e054-00144ff88e88", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category B: There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to sulfasalazine during pregnancy, but the role of sulfasalazine in these defects has not been established. However, oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see Drug Interactions ) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs. A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population. 1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation. 2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population. 3 No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy." ], "pediatric_use": [ "Pediatric: Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose.", "Pediatric Use: Safety and effectiveness in pediatric patients below the age of two years have not been established." ], "inactive_ingredient": [ "Inactive Ingredients: corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc." ], "contraindications": [ "CONTRAINDICATIONS Sulfasalazine tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE None reported." ], "warnings": [ "WARNINGS Only after critical appraisal should sulfasalazine tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving sulfasalazine (see PRECAUTIONS, Laboratory Tests ). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue sulfasalazine if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with sulfasalazine. For a patient who develops a new infection during treatment with sulfasalazine, perform a prompt and complete diagnostic workup for infection and myelosuppression. Caution should be exercised when considering the use of sulfasalazine in patients with a history of recurring or chronic infections or with underlying conditions or concomitant drugs which may predispose patients to infections. Severe hypersensitivity reactions may include internal organ involvement, such as hepatitis, nephritis, myocarditis, mononucleosis-like syndrome (i.e., pseudomononucleosis), hematological abnormalities (including hematophagic histiocytosis), and/or pneumonitis including eosinophilic infiltration. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of sulfasalazine. Patients are at highest risk for these events early in therapy, with most events occurring within the first month of treatment. Sulfasalazine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia and systemic symptoms have been reported in patients taking sulfasalazine. Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Sulfasalazine should be discontinued if an alternative etiology for the signs or symptoms cannot be established." ], "pregnancy": [ "Pregnancy: Teratogenic Effects: Pregnancy Category B: There are no adequate and well-controlled studies of sulfasalazine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 6 times the human maintenance dose of 2 g/day based on body surface area and have revealed no evidence of impaired female fertility or harm to the fetus due to sulfasalazine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. There have been case reports of neural tube defects (NTDs) in infants born to mothers who were exposed to sulfasalazine during pregnancy, but the role of sulfasalazine in these defects has not been established. However, oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation (see Drug Interactions ) and diminish the effect of periconceptional folic acid supplementation that has been shown to decrease the risk of NTDs. A national survey evaluated the outcome of pregnancies associated with inflammatory bowel disease (IBD). In a group of 186 women treated with sulfasalazine alone or sulfasalazine and concomitant steroid therapy, the incidence of fetal morbidity and mortality was comparable to that for 245 untreated IBD pregnancies as well as to pregnancies in the general population. 1 A study of 1,455 pregnancies associated with exposure to sulfonamides indicated that this group of drugs, including sulfasalazine, did not appear to be associated with fetal malformation. 2 A review of the medical literature covering 1,155 pregnancies in women with ulcerative colitis suggested that the outcome was similar to that expected in the general population. 3 No clinical studies have been performed to evaluate the effect of sulfasalazine on the growth development and functional maturation of children whose mothers received the drug during pregnancy. Clinical Considerations: Sulfasalazine and its metabolite, sulfapyridine, pass through the placenta. Sulfasalazine and its metabolite are also present in human milk. In the newborn, sulfonamides compete with bilirubin for binding sites on the plasma proteins and may cause kernicterus. Although sulfapyridine has been shown to have a poor bilirubin-displacing capacity, monitor the newborn for the potential for kernicterus. A case of agranulocytosis has been reported in an infant whose mother was taking both sulfasalazine and prednisone throughout pregnancy." ], "nursing_mothers": [ "Nursing Mothers: Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy, Clinical Considerations ). Insignificant amounts of sulfasalazine have been found in milk, whereas levels of the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in the maternal serum. Caution should be exercised when sulfasalazine is administered to a nursing mother. There are reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine. In cases where the outcome was reported, bloody stools or diarrhea resolved in the infant after discontinuation of sulfasalazine in the mother or discontinuation of breastfeeding. Due to limited data, a causal relationship between sulfasalazine exposure and bloody stools or diarrhea cannot be confirmed or denied. Monitor human milk fed infants of mothers taking sulfasalazine for signs and symptoms of diarrhea and/or bloody stools." ], "spl_product_data_elements": [ "Sulfasalazine sulfasalazine STARCH, CORN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE K30 TALC SULFASALAZINE SULFASALAZINE gold-colored 5904;V" ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The dosage of sulfasalazine tablets should be adjusted to each individual's response and tolerance. Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses. Maintenance Therapy: Adults: 2 g daily. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to sulfasalazine tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of sulfasalazine should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of sulfasalazine and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose. Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients, 4 7 of 8 patients, 5 and 19 of 20 patients. 6 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine.", "Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses.", "Maintenance Therapy: Adults: 2 g daily. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to sulfasalazine tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of sulfasalazine should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels. If symptoms of gastric intolerance (anorexia, nausea, vomiting, etc.) occur after the first few doses of sulfasalazine, they are probably due to increased serum levels of total sulfapyridine and may be alleviated by halving the daily dose of sulfasalazine and subsequently increasing it gradually over several days. If gastric intolerance continues, the drug should be stopped for 5 to 7 days, then reintroduced at a lower daily dose. Some patients may be sensitive to treatment with sulfasalazine. Various desensitization-like regimens have been reported to be effective in 34 of 53 patients, 4 7 of 8 patients, 5 and 19 of 20 patients. 6 These regimens suggest starting with a total daily dose of 50 to 250 mg sulfasalazine initially, and doubling it every 4 to 7 days until the desired therapeutic level is achieved. If the symptoms of sensitivity recur, sulfasalazine should be discontinued. Desensitization should not be attempted in patients who have a history of agranulocytosis, or who have experienced an anaphylactoid reaction while previously receiving sulfasalazine." ], "adverse_reactions": [ "ADVERSE REACTIONS The most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia and cyanosis, which may occur at a frequency of one in every thirty patients or less. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 mcg/mL, the incidence of adverse reactions tends to increase. Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when sulfasalazine tablets are administered. Less common or rare adverse reactions include: Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome. Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell's syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, and alopecia. Gastrointestinal reactions: hepatitis, hepatic failure, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis. Central nervous system reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus, and drowsiness. Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome. Other reactions: urine discoloration and skin discoloration. The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species. Postmarketing Reports The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine: Blood dyscrasias: pseudomononucleosis Cardiac disorders: myocarditis Hepatobiliary disorders: reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatitis cholestatic, cholestasis and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported. Immune system disorders: anaphylaxis Metabolism and nutrition system disorders: folate deficiency Renal and urinary disorders: nephrolithiasis Respiratory, thoracic and mediastinal disorders: oropharyngeal pain Skin and subcutaneous tissue disorders: angioedema, purpura Vascular disorders: pallor" ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181485 Rev 3/14 R7" ], "use_in_specific_populations": [ "Special Populations Elderly: Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. The clinical impact of this is unknown. Pediatric: Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose. Acetylator Status: The metabolism of SP to AcSP is mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist. Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. These subjects will display a prolonged plasma half-life for SP (14.8 hours vs 10.4 hours) and an accumulation of higher plasma levels of SP than fast acetylators. The clinical implication of this is unclear; however, in a small pharmacokinetic trial where acetylator status was determined, subjects who were slow acetylators of SP showed a higher incidence of adverse events. Gender: Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA.", "Acetylator Status: The metabolism of SP to AcSP is mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist. Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. These subjects will display a prolonged plasma half-life for SP (14.8 hours vs 10.4 hours) and an accumulation of higher plasma levels of SP than fast acetylators. The clinical implication of this is unclear; however, in a small pharmacokinetic trial where acetylator status was determined, subjects who were slow acetylators of SP showed a higher incidence of adverse events.", "Gender: Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA." ], "laboratory_tests": [ "Laboratory Tests: Complete blood counts, including differential white cell count and liver function tests, should be performed before starting sulfasalazine and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urinalysis and an assessment of renal function should also be done periodically during treatment with sulfasalazine. The determination of serum sulfapyridine levels may be useful since concentrations greater than 50 mcg/mL appear to be associated with an increased incidence of adverse reactions." ], "how_supplied": [ "HOW SUPPLIED Sulfasalazine Tablets USP, 500 mg are round, gold-colored, scored tablets, debossed \"5904\" and \"V\" on one side and plain on the reverse side. They are available in the following package sizes: Bottles of 100: 0603-5801-21 Bottles of 180: 0603-5801-04 Bottles of 500: 0603-5801-28 Bottles of 1000: 0603-5801-32 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients: Patients should be informed of the possibility of adverse reactions and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. They should also be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be reduced by continued administration of sulfasalazine at a maintenance dosage. Patients should be instructed to take sulfasalazine in evenly divided doses preferably after meals. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin." ], "package_label_principal_display_panel": [ "Principal Display Panel Sulfazine® 500mg (Sulfasalazine Tablets, USP 500mg) 30 Tablets NDC 10544-288-30 Label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Pharmacodynamics The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of SSZ, SP, and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. Pharmacokinetics In vivo studies have indicated that the absolute bioavailability of orally administered SSZ is less than 15% for parent drug. In the intestine, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Of the two species, SP is relatively well absorbed from the intestine and highly metabolized, while 5-ASA is much less well absorbed. Absorption: Following oral administration of 1 g of SSZ to 9 healthy males, less than 15% of a dose of SSZ is absorbed as parent drug. Detectable serum concentrations of SSZ have been found in healthy subjects within 90 minutes after the ingestion. Maximum concentrations of SSZ occur between 3 and 12 hours post-ingestion, with the mean peak concentration (6 mcg/mL) occurring at 6 hours. In comparison, peak plasma levels of both SP and 5-ASA occur approximately 10 hours after dosing. This longer time to peak is indicative of gastrointestinal transit to the lower intestine where bacteria mediated metabolism occurs. SP apparently is well absorbed from the colon with an estimated bioavailability of 60%. In this same study, 5-ASA is much less well absorbed from the gastrointestinal tract with an estimated bioavailability of from 10 to 30%. Distribution: Following intravenous injection, the calculated volume of distribution (Vdss) for SSZ was 7.5 ± 1.6 L. SSZ is highly bound to albumin (>99.3%) while SP is only about 70% bound to albumin. Acetylsulfapyridine (AcSP), the principal metabolite of SP, is approximately 90% bound to plasma proteins. Metabolism: As mentioned above, SSZ is metabolized by intestinal bacteria to SP and 5-ASA. Approximately 15% of a dose of SSZ is absorbed as parent and is metabolized to some extent in the liver to the same two species. The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours. The primary route of metabolism of SP is via acetylation to form AcSP. The rate of metabolism of SP to AcSP is dependent upon acetylator phenotype. In fast acetylators, the mean plasma half-life of SP is 10.4 hours while in slow acetylators, it is 14.8 hours. SP can also be metabolized to 5-hydroxy-sulfapyridine (SPOH) and N-acetyl-5-hydroxy-sulfapyridine. 5-ASA is primarily metabolized in both the liver and intestine to N-acetyl-5-aminosalicylic acid via a non-acetylation phenotype dependent route. Due to low plasma levels produced by 5-ASA after oral administration, reliable estimates of plasma half-life are not possible. Excretion: Absorbed SP and 5-ASA and their metabolites are primarily eliminated in the urine either as free metabolites or as glucuronide conjugates. The majority of 5-ASA stays within the colonic lumen and is excreted as 5-ASA and acetyl-5-ASA with the feces. The calculated clearance of SSZ following intravenous administration was 1 L/hr. Renal clearance was estimated to account for 37% of total clearance. Special Populations Elderly: Elderly patients with rheumatoid arthritis showed a prolonged plasma half-life for SSZ, SP, and their metabolites. The clinical impact of this is unknown. Pediatric: Small studies have been reported in the literature in children down to the age of 4 years with ulcerative colitis and inflammatory bowel disease. In these populations, relative to adults, the pharmacokinetics of SSZ and SP correlated poorly with either age or dose. Acetylator Status: The metabolism of SP to AcSP is mediated by polymorphic enzymes such that two distinct populations of slow and fast metabolizers exist. Approximately 60% of the Caucasian population can be classified as belonging to the slow acetylator phenotype. These subjects will display a prolonged plasma half-life for SP (14.8 hours vs 10.4 hours) and an accumulation of higher plasma levels of SP than fast acetylators. The clinical implication of this is unclear; however, in a small pharmacokinetic trial where acetylator status was determined, subjects who were slow acetylators of SP showed a higher incidence of adverse events. Gender: Gender appears not to have an effect on either the rate or the pattern of metabolites of SSZ, SP, or 5-ASA." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility: Two-year oral carcinogenicity studies were conducted in male and female F344/N rats and B6C3F1 mice. Sulfasalazine was tested at 84 (496 mg/m 2 ), 168 (991 mg/m 2 ), and 337.5 (1991 mg/m 2 ) mg/kg/day doses in rats. A statistically significant increase in the incidence of urinary bladder transitional cell papillomas was observed in male rats. In female rats, two (4%) of the 337.5 mg/kg rats had transitional cell papilloma of the kidney. The increased incidence of neoplasms in the urinary bladder and kidney of rats was also associated with an increase in the renal calculi formation and hyperplasia of transitional cell epithelium. For the mouse study, sulfasalazine was tested at 675 (2025 mg/m 2 ), 1350 (4050 mg/m 2 ), and 2700 (8100 mg/m 2 ) mg/kg/day. The incidence of hepatocellular adenoma or carcinoma in male and female mice was significantly greater than the control at all doses tested. Sulfasalazine did not show mutagenicity in the bacterial reverse mutation assay (Ames test) and in L51784 mouse lymphoma cell assay at the HGPRT gene. However, sulfasalazine showed equivocal mutagenic response in the micronucleus assay of mouse and rat bone marrow and mouse peripheral RBC and in the sister chromatid exchange, chromosomal aberration, and micronucleus assays in lymphocytes obtained from humans. Impairment of male fertility was observed in reproductive studies performed in rats at a dose of 800 mg/kg/day (4800 mg/m 2 ). Oligospermia and infertility have been described in men treated with sulfasalazine. Withdrawal of the drug appears to reverse these effects." ], "overdosage": [ "OVERDOSAGE There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. There are no documented reports of deaths due to ingestion of large single doses of sulfasalazine. Doses of sulfasalazine tablets of 16 g per day have been given to patients without mortality. A single oral dose of 12 g/kg was not lethal to mice. Instructions for Overdosage: Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine. If kidney function is normal, force fluids. If anuria is present, restrict fluids and salt, and treat appropriately. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The low molecular weight of sulfasalazine and its metabolites may facilitate their removal by dialysis.", "Instructions for Overdosage: Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine. If kidney function is normal, force fluids. If anuria is present, restrict fluids and salt, and treat appropriately. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The low molecular weight of sulfasalazine and its metabolites may facilitate their removal by dialysis." ] }, { "effective_time": "20120725", "inactive_ingredient": [ "INACTIVE INGREDIENTS Lactose, magnesium stearate." ], "references": [ "The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States." ], "purpose": [ "PURPOSE itchy, watery eyes red burning eyes and sneezing nasal congestion, coryza burning and swelling of the eye lids sneezing, runny nose, hay fever hay fever, sneezing, runny nose dry cough, hay fever itchy eyes, nasal congestion" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "WARNINGS Stop use and ask a doctor if symptoms worsen or persist for more than 7 days. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "ALLERGY REAL RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFICINALIS, SABADILLA, STICTA PULMONARIA, ARALIA RACEMOSA, CUPRUM METALLICUM ONION ONION ARSENIC TRIOXIDE ARSENIC CATION (3+) STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED EUPHRASIA STRICTA EUPHRASIA STRICTA SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED LOBARIA PULMONARIA LOBARIA PULMONARIA ARALIA RACEMOSA ROOT ARALIA RACEMOSA ROOT COPPER COPPER LACTOSE MAGNESIUM STEARATE" ], "ask_doctor": [ "Stop use and ask a doctor if symptoms worsen or persist for more than 7 days. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children." ], "other_safety_information": [ "OTHER INFORMATION Store at room temperature (68 - 77F). Do not use if seal is broken or missing." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Chew tablets and let dissolve in mouth. Do not use more than directed. Do not take with food. Repeat 3 times daily and reduce intake with improvement or as directed by a health professional. Age Dose Adults and children 12 years of age and older 2 tablets Children 2 to 11 years of age 1 tablet Children under 2 years of age Ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children." ], "package_label_principal_display_panel": [ "CARTON image description" ], "indications_and_usage": [ "USES This homeopathic medicine helps relieve symptoms of allergies: - nasal congestion - runny nose - sneezing - itchy, watery eyes" ], "set_id": "10113f30-729c-40ac-b198-2aca110c1048", "id": "fb47af0c-9c56-4c2d-8ad4-b5c439942724", "active_ingredient": [ "ACTIVE INGREDIENTS HPUS Allium cepa (Onion) 3X Arsenicum album (Arsenous trioxyde) 8X Nux vomica (Poison nut) 3X Euphrasia officinalis (Eyebright) 3X Sabadilla (Sabadilla) 1X Sticta pulmonaria (Lungwort) 1X Aralia racemosa (Spikenard) 6X Cuprum metallicum (Metallic copper) 8X" ], "dosage_and_administration_table": [ "
Age Dose
Adults and children 12 years of age and older 2 tablets
Children 2 to 11 years of age 1 tablet
Children under 2 years of age Ask a doctor
" ] }, { "effective_time": "20150302", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure" ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected." ], "storage_and_handling": [ "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "104a3cba-6ed9-48b3-e054-00144ff8d46c", "id": "104fea5c-cb2d-16c3-e054-00144ff88e88", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets, USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 FD&C RED NO. 40 CLONIDINE HYDROCHLORIDE CLONIDINE light tan 25;41;V Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO CLONIDINE HYDROCHLORIDE CLONIDINE 25;42;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181999 R6/12-R6" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed \"25\" bisect \"41\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2957-10 Bottles of 90: NDC 0603-2957-02 Bottles of 100: NDC 0603-2957-21 Bottles of 180: NDC 0603-2957-04 Bottles of 500: NDC 0603-2957-28 Bottles of 1000: NDC 0603-2957-32 Bottles of 2500: NDC 0603-2957-30 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2958-10 Bottles of 100: NDC 0603-2958-21 Bottles of 500: NDC 0603-2958-28 Bottles of 1000: NDC 0603-2958-32 Bottles of 2500: NDC 0603-2958-30 0.3 mg: peach, oval, scored, convex, debossed \"25\" bisect \"43\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2959-10 Bottles of 100: NDC 0603-2959-21 Bottles of 500: NDC 0603-2959-28 Bottles of 1000: NDC 0603-2959-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes." ], "package_label_principal_display_panel": [ "Principal Display Panel Clonidine Hydrochloride Tablets, USP 0.1mg 90 Tablets NDC 10544-196-90 Label", "PrincipalDisplay Panel Clonidine Hydrochloride Tablets, USP 0.2mg 90 Tablets NDC 10544-199-90 Label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "effective_time": "20110124", "drug_interactions": [ "Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect." ], "precautions": [ "PRECAUTIONS: General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol. Information for Patients: Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. Pregnancy: Pregnancy Category C: It is not known whether Dallergy ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy ® is administered to a nursing mother. Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established." ], "description": [ "DESCRIPTION: Each Dallergy ® Tablet contains: Chlorpheniramine Maleate ................................................4 mg Phenylephrine Hydrochloride ..........................................10 mg Methscopolamine Nitrate ...............................................1.25 mg Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorphenyl)- N,N -dimethyl, (Z)-2-butenedioate (1:1), having the following structural formula: Figure 1: Chlorpheniramine Maleate C 16 H 19 ClN 2 ·C 4 H 4 O 4 M.W. 390.86 Phenylephrine HCl is a decongestant having the chemical name Benzenemethanol, 3-hydroxy- α-[(methylamino)methyl]-, hydrochloride, having the following structural formula: Figure 2: Phenylephrine Hydrochloride C 9 H 13 NO 2 ·HCl M.W. 203.67 Methscopolamine is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo[3.3.1.0 2,4 ] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9,9-dimethyl-, nitrate, [7-(S)-(1α,2β,4β,5α,7β)]-, having the following structural formula: Figure 3: Methscopolamine Nitrate C 17 H 24 NO 4 · NO 3 M.W. 380.4 Dallergy ® Tablets contain ingredients of the following therapeutic classes: antihistamine, nasal decongestant, and anticholinergic agent." ], "general_precautions": [ "General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol." ], "storage_and_handling": [ "Storage and Handling Store at controlled room temperature 20º-25º C (68º – 77º F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured for: Laser, LLC d/b/a Laser Greenville, SC 29615 Rev. 01/11" ], "indications_and_usage": [ "INDICATIONS AND USAGE: For the relief of upper respiratory symptoms associated with allergies and the common cold, such as nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever." ], "set_id": "104bfa08-00d4-471f-8180-9b24e96a2934", "id": "86b8c058-59ed-43ad-96fb-a32ddcc226fa", "pediatric_use": [ "Pediatric Use: Safety and effectiveness in pediatric patients under 6 years of age have not been established." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS calcium phosphate, magnesium stearate, methylcellulose, povidone and stearic acid" ], "contraindications": [ "CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack." ], "warnings": [ "WARNINGS: Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur." ], "pregnancy": [ "Pregnancy: Pregnancy Category C: It is not known whether Dallergy ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy ® is administered to a nursing mother." ], "spl_product_data_elements": [ "Dallergy Chlorpheniramine Maleate, Phenylephrine Hydrochloride and Methscopolamine Nitrite CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2208 (4000 MPA.S) POVIDONE K30 STEARIC ACID LAS160" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Adults and children 12 years and older: one Dallergy ® Tablet. Children 6 to under 12 years of age: one-half tablet. May be repeated in 4 to 6 hours if required for relief. Not to exceed 4 doses in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS: Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children)." ], "how_supplied": [ "HOW SUPPLIED Bottles of 100 (NDC 0277-0160-01) white, scored tablets, debossed “LAS” to the left of the score and “160” to the right. The opposite side of the tablet is plain. Storage and Handling Store at controlled room temperature 20º-25º C (68º – 77º F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured for: Laser, LLC d/b/a Laser Greenville, SC 29615 Rev. 01/11" ], "information_for_patients": [ "Information for Patients: Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Figure 4: Container Label 86b8c058-figure-01 86b8c058-figure-02 86b8c058-figure-03 86b8c058-figure-04" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY: Chlorpheniramine maleate is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but again, a significant proportion of patients do experience this effect. Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation. Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory effects on the respiratory system." ], "overdosage": [ "OVERDOSAGE AND TREATMENT OF OVERDOSE: In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage. The installation of activated charcoal into the stomach also should be considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should be used." ] }, { "effective_time": "20130702", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if ■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "do_not_use": [ "Do not use ■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "10874e99-e7fa-4994-9af8-7e203262b1cc", "id": "096b79d6-3275-42b2-99ba-fed836ade8dc", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-356-0783" ], "spl_product_data_elements": [ "Rapid Comfort Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 Rapid Comfort Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Label Safety Ibuprofen Label 60683-083 Lab Safety Ibuprofen Label 60683-083 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-083", "Lab Safety Ibuprofen Label 60683-082 Lab Safety Ibuprofen Label 60683-082 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-082" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "108f8ac2-7b89-422d-9bb2-d26c4e01e939", "id": "0c3b148b-f2b9-3a0e-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100713", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Inositol, Iodine (from Potassium Iodide), Magnesium stearate, Potassium (from Potassium Iodide), Riboflavin, Rice flour, Selenium (from L-selenomethione), Silicon dioxide, Vegetable capsule (cellulose), Zinc (from Zinc Glycinate)." ], "purpose": [ "INDICATIONS: For temporary relief of weakness, fatigue and lightness of the head." ], "warnings": [ "WARNINGS: Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away. If pregnant or breast-feeding, seek advice of a health professional before use. Tamper seal: \"Sealed for your protection.\" Do not use if seal is broken or missing. WARNING: Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects." ], "questions": [ "Manufactured For: CMA 5510 Lafayette St. Indianapolis, IN 46254" ], "spl_product_data_elements": [ "Iodine Plus Capsule Thyroidinum, Thyroxine, Trilodothyronine, THYROID THYROID LEVOTHYROXINE LEVOTHYROXINE LIOTHYRONINE LIOTHYRONINE INOSITOL POTASSIUM IODIDE MAGNESIUM STEARATE RIBOFLAVIN RICE SELENOMETHIONINE SILICON DIOXIDE POWDERED CELLULOSE ZINC no color no text none" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: One capsule daily or as directed by a health professional." ], "package_label_principal_display_panel": [ "IODINE PLUS CAPSULES I + I 2 HOMEOPATHIC 120 CAPSULES Iodine Plus Capsules" ], "set_id": "10cd16de-7463-41b4-a3af-382a01a02058", "id": "cccabf04-6888-4c58-98dd-168cbbc0549e", "active_ingredient": [ "ACTIVE INGREDIENTS: Thyroidinum 12X, 30X, Thyroxine 8X, 12X, 30X, Triiodothyronine 8C, 30C, 200C." ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue 1, dextrose, flavors, magnesium stearate, maltodextrin, red 40, starch, sucralose, yellow 6, yellow 10. Safety sealed: Do not use if printed seal under cap is torn or missing" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in 24 hours if pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor." ], "spl_product_data_elements": [ "up and up extra strength smooth dissolving antacid Assorted Fruit Antacid Tablets CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID FD&C BLUE NO. 1 DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 STARCH, CORN SUCRALOSE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 light RP115 assorted" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor" ], "spl_unclassified_section": [ "Other information each tablet contains: elemental calcium 300mg store below 30°C (86°F).Keep the container tightly closed" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 11673-615-90 Compare to TUMS® Smoothies Assorted Fruit* extra strength smooth dissolving antacid calcium carbonate,750 mg fast relief of heartburn, acid indigestion and upset stomach ASSORTED FRUIT FLAVOR 90 TABLETS 90 CHEWABLE TABLETS 245 05 0761 R01 ID285492 Dist.by Target Corp. Mpls.,MN 55403 Made in U.S.A ©2015 Target Brands, Inc. Shop Target.com Questions?Call 1-800-910-6874 *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS®. up and up extra strength smooth dissolving antacid assorted Fruit" ], "indications_and_usage": [ "Uses relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms" ], "set_id": "10e50d70-213b-4507-800f-fe308d0f7335", "id": "10e50d70-213b-4507-800f-fe308d0f7335", "active_ingredient": [ "Active ingredient (per tablet) Calcium Carbonate USP 750mg" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide. Questions? 1-800-525-8747 Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.02/2008 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE TITANIUM DIOXIDE POLYETHYLENE GLYCOLS white to off-white round shape SZ;906" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Store between 20 to 25 C (68 to 77 F)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 21695-709-10 Bottle of 10 NDC 21695-709-14 Bottle of 14 NDC 21695-709-20 Bottle of 20 NDC 21695-709-30 Bottle of 30 Cetirizine HCl Tablets 10 mg antihistamine Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Cetirizine HCl 10mg" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "10f3966d-9cb8-4beb-b384-6b2428e92c22", "id": "d65cd557-92e1-49b0-9ff5-8479b0ed9f76", "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20120801", "inactive_ingredient": [ "INACTIVE INGREDIENTS aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Keep the carton. It contains important information. See end panel for expiration date. Distributed By MAJOR PHARMACEUTICALS 31778 Enterprise Drive LIVONIA, MI 48150, USA" ], "spl_product_data_elements": [ "Loratadine ODT Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White flat faced beveled edge RC17" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. keep in a dry place. use tablet immediately after opening individual blister." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MAJOR ® NDC 0904-5806-15 Non-Drowsy * Ages six years and older Original Prescription Strength Allergy 24 HOUR Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Allergy Relief Relief of: Sneezing Runny Nose Itchy Watery Eyes Itchy Throat or Nose No water needed. Melts in your mouth. Fruit Flavors 10 Tablets/10 Days of Relief 10 Orally Disintegrating Tablets * When taken as directed. See Drug Facts Panel. † Compare to the active ingredient of Claritin ® RediTabs ® † This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN ® and REDITABS ® are registered trademarks of Schering Corporation. This is the 10 count blister carton label for Major Loratadine orally disintegrating tablets, 10 mg." ], "indications_and_usage": [ "USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "111e6cdf-04fa-49fa-8d5f-e5fc5bd55a8e", "id": "d634e4e1-7b35-4f89-96ac-97d74cd36b0e", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine, USP 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20130708", "inactive_ingredient": [ "INACTIVE INGREDIENTS Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide" ], "purpose": [ "PURPOSE Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ranitidine Ranitidine RANITIDINE HYDROCHLORIDE RANITIDINE COLLOIDAL SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 TALC TITANIUM DIOXIDE OR;606" ], "ask_doctor": [ "Ask a doctor before use if you have frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "OTHER INFORMATION TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free" ], "do_not_use": [ "Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL GOOD NEIGHBOR PHARMACY † Compare to active ingredient in Zantac 75 ® NDC 46122-0223-72 Regular Strength Acid Reducer Ranitidine Tablets, USP 75 mg Acid Reducer Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach 60 Tablets Distributed By AmerisourceBergen 5103697/0613 60's bottle carton label" ], "indications_and_usage": [ "USES relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages" ], "set_id": "113d3844-0dfa-4ccf-852d-5a0559e52bcd", "id": "ace6f559-73e4-4853-a71f-5d3b7cb96031", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 mg)" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings:" ], "when_using": [ "When using this product Avoid alcoholic drinks. Marked drowsiness may occur. Excitability may occur, especially in children. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery." ], "spl_product_data_elements": [ "Diphenhydramine HCL Diphenhydramine HCL FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PH014" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture" ], "do_not_use": [ "Do not use With any other product containing Diphenhydramine HCL, including one applied topically." ], "package_label_principal_display_panel": [ "Principal Display Panel Blenheim Pharmacal, Inc. NDC 10544-166-15 Diphenhydramine HCl Capsules, USP 25mg 15 Capsules 25mg 15ct" ], "indications_and_usage": [ "Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes." ], "set_id": "117fead9-699d-57ae-e054-00144ff88e88", "id": "11a88159-9fdc-1983-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you have: Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Glaucoma If you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
Adults and children 12 years or over 1 to 2 capsule
Children 6 to under 12 years 1 capsule
Children under 6 years ask a doctor
" ] }, { "effective_time": "20150318", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Fexofenadine Hydrochloride Fexofenadine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POVIDONE TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE Peach 93;7252" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "storage_and_handling": [ "Other information do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "Principal Display Panel Fexofenadine Hydrochloride Tablets, 60mg 30 Tablets NDC 10544-231-30 60mg 30ct" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "11926194-a656-2bfb-e054-00144ff88e88", "id": "11926194-a657-2bfb-e054-00144ff88e88", "active_ingredient": [ "Active ingredient (in each tablet) Fexofenadine HCl 60 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
" ] }, { "effective_time": "20150318", "inactive_ingredient": [ "Inactive Ingredients croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid" ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Other Information each caplet contains: calcium 51 mg store at room temperature 15°-30°C (59°-86°F)" ], "warnings": [ "WARNINGS Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating a machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or Comments Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED Rugby® Duluth, Georgia 30097" ], "spl_product_data_elements": [ "Meclizine HCl Meclizine HCl CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID SILICON DIOXIDE MECLIZINE HYDROCHLORIDE MECLIZINE AP;117" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: 2-4 caplets once daily children under 12 years: ask a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Meclizine HCl Caplets, USP 12.5mg 6 Caplets NDC 10544-249-06 12.5mg 06ct" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting, or dizziness due to motion sickness" ], "set_id": "119415c4-86da-1626-e054-00144ff8d46c", "id": "119415c4-86db-1626-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient (in each caplet) Meclizine HCl 12.5 mg USP" ] }, { "effective_time": "20120301", "drug_interactions": [ "Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ).", "Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.", "Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).", "Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.", "Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.", "Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.", "Antitubercular drugs Serum concentrations of isoniazid may be decreased.", "Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.", "Cholestyramine Cholestyramine may increase the clearance of corticosteroids.", "Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.", "Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.", "Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.", "Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.", "Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.", "Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.", "Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.", "Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.", "Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.", "Skin Tests Corticosteroids may suppress reactions to skin tests.", "Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.", "Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination )." ], "geriatric_use": [ "Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered." ], "references": [ "REFERENCES Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63." ], "precautions": [ "PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement. Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal. Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored. Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay. Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid. Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer. Skin Tests Corticosteroids may suppress reactions to skin tests. Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use. Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infection: Vaccination ). Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.", "Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.", "Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism.", "Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.", "Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy. Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.", "Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION: Multiple Sclerosis .) An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.", "Ophthalmic Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored." ], "description": [ "DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg. This is an image of the formula for PredniSONE. Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "general_precautions": [ "General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement." ], "storage_and_handling": [ "Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "indications_and_usage": [ "INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement" ], "set_id": "120ce39a-c2bc-4c07-94b5-c7d9fc0da7ec", "id": "943821b5-8382-43e2-a18b-ac8e9cde746e", "teratogenic_effects": [ "Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.", "Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "pediatric_use": [ "Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose." ], "inactive_ingredient": [ "Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate." ], "contraindications": [ "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components." ], "warnings": [ "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation.", "Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.", "Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.", "Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease). Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation.", "General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection.", "Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents ).", "Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria.", "Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.", "Vaccination Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines may be diminished and cannot be predicted. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids as replacement therapy (e.g., for Addison’s disease).", "Viral Infections Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.", "Ophthalmic Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex because of possible corneal perforation." ], "pregnancy": [ "Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism." ], "nursing_mothers": [ "Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." ], "spl_product_data_elements": [ "Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5094;V Prednisone Prednisone PREDNISONE PREDNISONE SILICON DIOXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A POTATO 5093;V" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.", "Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)", "Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects. During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy. The following should be kept in mind when considering alternate day therapy: Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone). The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am). In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered." ], "adverse_reactions": [ "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, increased motor activity, insomnia, ischemic neuropathy, long-term memory loss, mania, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditions, restlessness, schizophrenia, verbal memory loss, vertigo, withdrawn behavior. Ophthalmic blurred vision, cataracts (including posterior subcapsular cataracts), central serous chorioretinopathy, establishment of secondary bacterial, fungal and viral infections, exophthalmos, glaucoma, increased intraocular pressure (see PRECAUTIONS: Ophthalmic ), optic nerve damage, papilledema. Other abnormal fat deposits, aggravation/masking of infections, decreased resistance to infection (see WARNINGS: Infection ), hiccups, immunosuppression, increased or decreased motility and number of spermatozoa, malaise, insomnia, moon face, pyrexia." ], "spl_unclassified_section": [ "Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "how_supplied": [ "HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Unit-of-Use (48 Tablets) NDC 54868-5213-0 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Unit-of-Use (48 Tablets) NDC 54868-4095-0 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]." ], "information_for_patients": [ "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL image of 10 mg package label", "PRINCIPAL DISPLAY PANEL image of 5 mg package label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients." ] }, { "effective_time": "20150309", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, tapioca starch**, tartaric acid** ** may contain these ingredients" ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use ■ laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have ■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel movements that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Senna Sennosides SENNOSIDES SENNOSIDES CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL STARCH, TAPIOCA TARTARIC ACID Light TCL;080" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Directions" ], "spl_unclassified_section": [ "Other Information ■ each tablet contains: calcium 25 mg, sodium 2 mg. VERY LOW SODIUM ■ store at 25°C (77°F) excursions permitted between 15°–30°C (59°–86°F) Compare to the active ingredient in Senokot ® Tablets * *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®. 191R Rev 01/10 Distributed by MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 Senna TABLETS Natural Vegetable Laxative For Gentle, Predictable Relief of Constipation Sennosides 8.6 mg EACH MAJOR® THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN Cardinal Health Zanesville, OH 43701 OI86350710" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Tablets Sennosides 8.6 mg blister", "Package/Label Principal Display Panel Senna Tablets Sennosides 8.6 mg QTY 30 carton" ], "indications_and_usage": [ "Uses ■ relieves occasional constipation (irregularity) ■ generally causes a bowel movement in 6-12 hours" ], "set_id": "123af780-1165-4a00-8cbc-09cc5704fcba", "id": "d44f93cc-2e2c-4eab-bf97-7bdd504397d1", "active_ingredient": [ "Active ingredient Drug Facts Active Ingredient (in each tablet) Sennosides 8.6 mg" ] }, { "effective_time": "20121012", "inactive_ingredient": [ "Inactive ingredients Acacia Gum, Calcium Carbonate, Croscarmellose Sodium, Dextrose, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Propylene Glycol, Silicon Dioxide, Stearic Acid, Triacetin." ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Adverse Drug Event call (800) 616-2471" ], "spl_product_data_elements": [ "Senna-Lax SENNOSIDES A AND B SENNOSIDES A AND B SENNOSIDES A AND B ACACIA CALCIUM CARBONATE CROSCARMELLOSE SODIUM DEXTROSE HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TRIACETIN Biconvex GPI;W2" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years of age ask a doctor ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "do_not_use": [ "Do not use laxative products for longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Sennosides 8.6mg Tablet Image File" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours" ], "set_id": "1283a8ff-00f4-11af-4357-ae102066fe65", "id": "5a42b29a-d47a-4c3e-aeeb-d93415d715f9", "active_ingredient": [ "Active ingredient (in each tablet) Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
age starting dosage maximum dosage
adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day
children under 2 years of age ask a doctor ask a doctor
" ] }, { "effective_time": "20131213", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? call 1-800-223-0182" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses for the temporary relief of: sinus congestion and pressure headache minor aches and pains nasal congestion" ], "set_id": "12859e74-4d61-4cb6-bd20-21c4f48e90d4", "id": "1b14fdc7-e2f6-4b18-ba46-39291b44a054", "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours do not exceed 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide" ], "warnings": [ "Warnings Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage. Do not use with another product containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "Sinutab Sinus MAXIMUM STRENGTH acetaminophen and phenylephrine hydrochloride acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine carnauba wax starch, corn FD&C yellow NO. 6 aluminum oxide hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 powdered cellulose sodium starch glycolate Type A Potato titanium dioxide peach colored SI;WL;89" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not exceed 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts", "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with another product containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH DOSE NDC 50580-307-24 NO DROWSINESS Sinutab ® SINUS Acetaminophen and phenylephrine HCl caplets Pain reliever, Nasal decongestant Fast Relief of: Headache Nasal Congestion Sinus Pressure/Pain Easy to Swallow Does not contain Pseudoephedrine 24 COATED CAPLETS* *CAPSULE-SHAPED TABLETS PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20150401", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredient : Food material powders (Damiana extract powder, Soy protein isolate, Cordyceps gunnii fruiting body, Corni fructus powder, Lycii fructus powder, Astragalus membranaceus powder, Cynanchum root and rhizome, Gelatinized maca powder), Lactose (Galacto fructose) powder, L-Arginine, L-Lysine monohydrochloride, Silicon dioxide, Hydroxypropyl methylcellulose, Sucrose fatty acid ester, Zinc oxide, Magnesium stearate." ], "purpose": [ "PURPOSE Stimulant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children" ], "warnings": [ "WARNING If you take any serious medications or medical condition, consult your doctor." ], "when_using": [ "USES To help the treatment and prevention of blood circulation, prostate, erectile dysfunction." ], "spl_product_data_elements": [ "SINGISO Red Ginseng CORNUS OFFICINALIS FRUIT CORDYCEPS GUNNII FRUITING BODY MAGNESIUM STEARATE ASTRAGALUS PROPINQUUS ROOT SOY PROTEIN LYCIUM BARBARUM FRUIT CYNANCHUM STAUNTONII ROOT LEPIDIUM MEYENII WHOLE LACTOSE LYSINE HYDROCHLORIDE SILICON DIOXIDE HYPROMELLOSES SUCROSE ZINC OXIDE ASIAN GINSENG ASIAN GINSENG TURNERA DIFFUSA LEAF" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTION Take 1 tablet a day (after having dinner, before sleep)" ], "spl_unclassified_section": [ "SPL UNCLASSIFIED SECTION Do not exceed the recommended dosage. To assure freshness and potency, store at room temperature 15 o C - 30 o C. Store away from heat, light and moisture, if you are pregnant, nursing, taking any medication or have a medical condition, please consult your healthcare practitioner before taking any dietary supplement." ], "package_label_principal_display_panel": [ "PACKAGING PACKAGING" ], "indications_and_usage": [ "OTHER INFORMATION Keep product out of direct sunlight, high temperature and humidity. Store in a cool dry place. Any items past the expiration date or damaged in transit can be exchanged where you originally purchased the item" ], "set_id": "12b1c712-fa08-31c0-e054-00144ff8d46c", "id": "12b1c712-fa09-31c0-e054-00144ff8d46c", "active_ingredient": [ "ACTIVE INGREDIENTS Red ginseng 15.63%" ] }, { "effective_time": "20120305", "inactive_ingredient": [ "Inactive Ingredients Croscarmellose Sodium Crospovidone, DandC Yellow No. 10, FDandC Blue No. 1 Hydrogenated Vegetable Oil, Lactose Anhydrous, Magnesium Stearate, Powedered Cellulose, Pregelatinized starch." ], "purpose": [ "Purpose Anti-diarrheal" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you ever had a rash or other allergic reaction to loperamide HCl Do Not Use if you have bloody or black stool Ask a doctor before use if you have high fever (greater than 101F) mucus present in your stool history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics Stop use and ask a doctor if diarrhea lasts for more than 2 days If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll free (800) 858-3889" ], "spl_product_data_elements": [ "Enterocina LOPERAMIDE HCL LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 ANHYDROUS LACTOSE MAGNESIUM STEARATE POWDERED CELLULOSE GREEN CAPSULE 122" ], "ask_doctor": [ "Ask a doctor before use if you have high fever (greater than 101F) mucus present in your stool history of liver disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions drink plenty of clear fluids to hep prevent dehydration, which may accompany diarrhea Find right dose on chart. If possible, use weight to dose, otherwise, use age. Adults and children 12 years of age and older: Take 2 tablets after the first loose bowel movement and 1 tablet after each subsequent loose bowel movement and 1 tablet after each subsequent loose bowel movement; but no more than 4 tablets a day. Children 9-11 years (60-95lbs): Take 1 tablet after the first loose bowel movement and 1/2 tablet after each subsequent loose bowel movement; but not more than 3 tablets a day. Children 6-8 years (48-59 lbs): Take 1 tablet after the first loose bowel movement and 1/2 tablet after each subsequent loose bowel movement; but not more than 2 tablets a day. CHILDREN UNDER 6 YEARS OLD (UP TO 47LBS): Consult a physician. Not intended for use in children under 6years old." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days" ], "storage_and_handling": [ "Other information Store at room temperature 15 to 30C (59-86F). See side panel for lot number and expiration date." ], "do_not_use": [ "Do Not Use if you have bloody or black stool" ], "package_label_principal_display_panel": [ "Package Labeling Enterocina Tablets USP, 2mg Anti- Diarrheal 12 Caplets Each caplet contains Loperamide HCl USP, 2mg Distributed by: De La Cruz Producs, A division of DLC Laboratories, Inc, Paramount, CA 97723 www.dlclaboratories.com Enterocina Enterocina" ], "indications_and_usage": [ "Use controls symptoms of diarrhea, including Traveler's Diarrhea." ], "set_id": "12ecb20f-dc52-4d07-a75c-45ef885df69a", "id": "030a7008-80d0-4d97-a85e-0207d55eb6b9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking antibiotics" ], "active_ingredient": [ "Active Ingredients Loperamide HCl 2mg Purpose Anti-diarrheal" ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "MEDIQUE I-PRIN Ibuprofen SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST PLUS Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Dover Addaprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Otis Clapp Ultraprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Physicians Care Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Lab Safety Supply Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug Purpose Pain reliever/fever reducer Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever. Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain Questions or comments? 1-800-634-7680" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Medique® I-Prin Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 24 tablets (12 x 2) Compare active ingredient to Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 100 tablets (50 x 2) Compare active ingredient to: Genuine Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Plus Ibuprofen 200 mg See new warnings information Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets 250 tablets (125 x 2) Compare active ingredient to: Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Rapid Comfort SM Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film Coated Tablets Compare active ingredient to: Advil® Registered trademark of Whitehall-Robins See new warnings information 100 Tablets (50 x 2s) Tamper Evident Unit Dose Packets Dover Addaprin Pain Reliever-Fever Reducer Ibuprofen 200 MG. Tablets (NSAID) See new warnings information Dover Pharmaceutical Products of the highest quality and effectiveness Tamper Resistant Sealed Packets Unit Dose Packs 500 Tablets (250 Packets of 2) OC Otis Clapp Quality & Integrity Since 1840 Ultraprin ™ Pain Reliever-Fever Reducer (NSAID) Ibuprofen Tablets USP 200 mg For Deep Seated Pain See Warnings and directions on Side Panel See new warnings information Tear out along perforation to dispense Professional Healthcare 300 Tablets (150 Packets of 2) Physician's Care® Ibuprofen Anti-inflammatory, Fever Reducer & Pain Reliever (NSAID) Coated Tablets Compare active ingredient to: Advil® Registered trademark of Wyeth Corporation Tamper Evident Packets of 2 tablets See new warnings information Physicians Care® Registered trademark of Acme United Corporation 50 Packets (2 Tablets 200 mg Each) Medique Iprin Medi-First Ibuprofen Medi0First Plus Ibuprofen Lab Safety Ibuprofen Dover Addaprin Otis Clapp Ultraprin Physicians Care" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever." ], "set_id": "130baa8b-c8a0-4d72-94c9-6eb8dc8c7c29", "id": "07d899a0-08bc-57b3-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110330", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystalline cellulose." ], "purpose": [ "INDICATIONS: For temporary relief of muscle cramps and spasms most commonly affecting the legs, calves, feet, and toes." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Tamper seal: \"Sealed for your protection\". Do not use if seal is broken or missing." ], "questions": [ "Dist. by The Magni Group, Inc. McKinney, TX 75070 USA www.magnilife.com 800-645-9199" ], "spl_product_data_elements": [ "Muscle Cramp and Spasm Relief Causticum, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum, Veratrum album, CAUSTICUM CAUSTICUM CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP COPPER COPPER MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF TIN TIN VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE white round convex ML" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS: Adults and children 12 years and over dissolve 2 tablets under tongue twice a day. May be increased to 2 tablets 3 times a day, if needed. For children 12 and under, consult a health care professional. For maximum effectiveness, take tablets regularly and consistently. For some, it may take up to 4-6 weeks to achieve maximum results." ], "package_label_principal_display_panel": [ "MAGNI LIFE MUSCLE CRAMP AND SPASM RELIEF Relax Calm Soothe Ease Control Homeopathic Formula 125 Tablets Muscle Cramp and Spasm Relief" ], "indications_and_usage": [ "INDICATIONS: For temporary relief of muscle cramps and spasms most commonly affecting the legs, calves, feet, and toes." ], "set_id": "1333a24b-74e3-4a64-b6d0-8e174c528510", "id": "bd147e42-5527-41c3-b753-daa20755ebcd", "active_ingredient": [ "ACTIVE INGREDIENTS: Causticum 12X, 30X, Colocynthis 12X, 30X, Cuprum metallicum 12X, 30X, Magnesia phosphorica 12X, 30X, Phytolacca decandra 12X, 30, Rhus toxicodendron 12X, 30X, Stannum metallicum 12X, 30X, Veratrum album 12X, 30X." ] }, { "effective_time": "20091218", "spl_unclassified_section_table": [ "
Adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
Children under 6 years of age Ask a doctor
Consumers with liver or kidney disease Ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide." ], "purpose": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away." ], "when_using": [ "When using this product drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary." ], "questions": [ "Questions? Call 1-866-562-4597" ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine hypromellose lactose magnesium stearate starch, corn polyethylene glycol povidone titanium dioxide White Barrel Shaped CTN;5" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Directions Adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours. Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor", "Other Information store between 20° to 25°C (68° to 77°F)", "Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA. Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA." ], "do_not_use": [ "Warnings Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "Cetirizine Hydrochloride Tablets 5 mg Container Label NDC 16571-401-10 Original Prescription Strength Cetirizine Hydrochloride Tablets 5 mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 Tablets Allergy Indoor & Outdoor Allergies PACK PHARMACEUTICALS LLC Container Label" ], "set_id": "139536a1-b021-4ef3-902f-b618da5aaa44", "id": "89050554-8e16-41ce-88a5-30718b7f6f9c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active Ingredients Active Ingredients (in each tablet) Purpose Cetirizine HCl 5 mg.....................................................................................Antihistimine" ] }, { "effective_time": "20100924", "inactive_ingredient": [ "Inactive Ingredients Gluten Free Copovidone, Crospovidone, Magnesium Stearate, Mannitol, Mono-Ammonium Glycyrrhizinate, Natural & Artificial Cherry Flavors, Silicon Dioxide, Sodium Starch Glycolate, Sorbitol, Stearic Acid, Sucralose" ], "purpose": [ "Active Ingredients (in each tablet) Purpose Zincum Aceticum 2X Reduces duration and Zincum Gluconicum 1X severity of the common cold" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Stop use and ask doctor if Side effects occur. You may report side effects to FDA at 1-800-FDA-1088 . Rite Aid ® Pharmacy Cold Relief Eez Melts are formulated to shorten the duration and severity of the common cold and may not be effective for flu or allergies. Stop use and ask a doctor if symptoms persist. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "NBE Cherry Cold Remedy Fast Melting (Rite Aid) Zinc Acetate and Zinc Gluconate Zinc Acetate Zinc Zinc Gluconate Zinc Copovidone Crospovidone Magnesium Stearate Mannitol GLYCYRRHIZIN, AMMONIATED Silicon Dioxide SODIUM STARCH GLYCOLATE TYPE A POTATO Sorbitol Stearic Acid Sucralose CH2" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For Adults and Children 6 years old and older: Note: For maximum benefit, begin treatment at first sign of cold. Completely dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the onset of symptoms. Repeat every three hours until symptoms are gone, up to 5 tablets per day. For best results, use for an additional 48 hours after symptoms subside. To avoid minor stomach upset, do not take on an empty stomach. Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids. For Children under 6 years of age, consult a physician before use." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011" ], "stop_use": [ "Stop use and ask a doctor if symptoms persist." ], "active_ingredient_table": [ "
Active Ingredients (in each tablet) Purpose
Zincum Aceticum 2X Reduces duration and
Zincum Gluconicum 1X severity of the common cold
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 25 tablet carton RITE AID ® PHARMACY Compare to the active ingredients in Zicam ® RapidMelts ® Cold Remedy cold relief zincum aceticum, zincum gluconicum cherry flavor sugar free shortens the duration and severity of the common cold dissolves quickly in mouth without water take at the first sign of a cold homeopathic EEZ MELTS 25 QUICK DISSOLVING TABLETS Principal Display Panel - 25 tablet carton" ], "indications_and_usage": [ "Uses Reduces duration of the common cold Reduces severity of cold symptoms: Sore Throat, Stuffy Nose, Sneezing, Coughing, and Congestion" ], "set_id": "13a55f74-ea65-45ee-b74b-643e7b195b9c", "id": "2ecb6196-4b51-4c44-9b2e-08427183b629", "purpose_table": [ "
Active Ingredients (in each tablet) Purpose
Zincum Aceticum 2X Reduces duration and
Zincum Gluconicum 1X severity of the common cold
" ], "active_ingredient": [ "Active Ingredients (in each tablet) Purpose Zincum Aceticum 2X Reduces duration and Zincum Gluconicum 1X severity of the common cold" ] }, { "effective_time": "20130508", "inactive_ingredient": [ "Inactive ingredients water, pentylene glycol, nylon-12, polyethylene, glycerin, dimethicone, sodium acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, tocopheryl acetate, stearyl alcohol, butylene glycol, behenyl alcohol, phenoxyethanol, benzyl alcohol, cetyl alcohol, dimethiconol, PEG-100 stearate, polysorbate 80, sodium benzoate, sodium ascorbyl phosphate, cetearyl glucoside, cetearyl alcohol, disodium EDTA, stearic acid, laminaria saccharina extract, iodopropynyl butylcarbamate.", "OTHER INGREDIENTS Microcrystalline cellulose, hypromellose, sucrose, magnesium stearate, sodium caseinate, titanium dioxide, trisodium citrate dihydrate, propyl gallate (antioxidant preservative). Contains: Milk" ], "purpose": [ "Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 9.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 2.6% Sunscreen Oxybenzone 2.0% Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "We recommend that you keep Biovi out of the reach of children." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "WARNINGS We recommend that you keep Biovi out of the reach of children. TAMPER EVIDENT: Carton sealed for your protection. Do not use if capsule blister unit is open or torn." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions? 1-877-856-5521" ], "spl_product_data_elements": [ "Biovi Total Beauty Bifidobacterium longum subsp. infantis, Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone BIOVI Daily Balance Probiotic Supplement Bifidobacterium longum subsp. infantis Bifidobacterium longum subsp. infantis Bifidobacterium longum subsp. infantis cellulose, microcrystalline hypromelloses sucrose magnesium stearate sodium caseinate titanium dioxide trisodium citrate dihydrate propyl gallate cow milk BIOVI AM hydrate Daily Moisturizer Broad spectrum SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Oxybenzone Oxybenzone water pentylene glycol nylon-12 high density polyethylene glycerin dimethicone isohexadecane .alpha.-tocopherol acetate stearyl alcohol butylene glycol docosanol phenoxyethanol benzyl alcohol cetyl alcohol PEG-100 stearate polysorbate 80 sodium benzoate sodium ascorbyl phosphate cetearyl glucoside cetostearyl alcohol Edetate Disodium stearic acid saccharina latissima iodopropynyl butylcarbamate BIOVI PM nourish Night WATER CYCLOMETHICONE 5 GLYCERIN HIGH DENSITY POLYETHYLENE NIACINAMIDE PROPYLENE GLYCOL ALUMINUM STARCH OCTENYLSUCCINATE PANTHENOL DIMETHICONE PALMITOYL PENTAPEPTIDE-4 CARNOSINE .ALPHA.-TOCOPHEROL ACETATE GREEN TEA LEAF YEAST ALLANTOIN EDETATE DISODIUM C13-14 ISOPARAFFIN PEG-100 STEARATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE LAURETH-4 LAURETH-7 CITRIC ACID MONOHYDRATE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meaures including: limit time in sun, especially from 10 a .m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor", "Directions Take one capsule per day. Store at room temperature. For best results we recommend you store Biovi in the original blister package." ], "spl_unclassified_section": [ "BIOVI AM HYDRATE DAILY MOISTURIZER with UV SUNSCREEN SPF 15 Drug Facts", "BIOVI DAILY BALANCE BEAUTY CAPSULES PROBIOTIC SUPPLEMENT", "Distributed by TripleFin LLC 6000 Creek Road Cincinnati, OH 45242" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Other information protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin", "TAMPER EVIDENT: Carton sealed for your protection. Do not use if capsule blister unit is open or torn." ], "active_ingredient_table": [ "
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 9.0% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 2.6% Sunscreen
Oxybenzone 2.0% Sunscreen
", "
Supplement Facts
Serving Size: 1 Capsule
Servings Per Carton: 28
Amount Per Capsule
Contains 1 × 109 (one billion) live bacteria when manufactured, and provides an effective level of bacteria (1 × 107) until at least the "best by" date.
Bifidobacterium infantis 35624
(Bifantis ®) 4mgDaily Value (DV) not established
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton BIOVI total beauty starter kit DAILY | balance PROBIOTIC SUPPLEMENT Beauty Capsules SPF 15 AM | hydrate DAILY MOISTURIZER with UV SUNSCREEN BROAD SPECTRUM SPF 15 PM | nourish NIGHT CREAM with Vitamin B3 Complex DAILY MOISTURIZER WITH UV SUNSCREEN: 1.0 FL OZ (30 mL) NIGHT CREAM: 0.7 FL OZ (20 mL) PROBIOTIC SUPPLEMENT: 28 Capsules (4 Week Supply) Principal Display Panel - Kit Carton" ], "indications_and_usage": [ "Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "13adc6d4-1370-4665-9d3f-3ad4521e62b2", "id": "2887d563-4af6-491c-b411-31ddfb48cf40", "purpose_table": [ "
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 9.0% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 2.6% Sunscreen
Oxybenzone 2.0% Sunscreen
" ], "active_ingredient": [ "Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 9.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 2.6% Sunscreen Oxybenzone 2.0% Sunscreen", "Supplement Facts Serving Size: 1 Capsule Servings Per Carton: 28 Amount Per Capsule Contains 1 × 10 9 (one billion) live bacteria when manufactured, and provides an effective level of bacteria (1 × 10 7 ) until at least the \"best by\" date. Bifidobacterium infantis 35624 (Bifantis ®) 4mg Daily Value (DV) not established" ] }, { "effective_time": "20131115", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product. Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exeed recommended dosage. Stop use and ask a doctor if new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 7 days redness or swelling is present nervousness, dizziness, or sleeplessness occur cough comes back or occurs with rash or headache that lasts fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exeed recommended dosage." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Maximum Strength Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN FD&C BLUE NO. 1 MALTODEXTRIN CROSPOVIDONE MAGNESIUM STEARATE 44;616" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 7 days redness or swelling is present nervousness, dizziness, or sleeplessness occur cough comes back or occurs with rash or headache that lasts fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product." ], "package_label_principal_display_panel": [ "Principal display panel exchange select™ *Compare To The Active Ingredients in Maximum Strength Mucinex® FAST-MAX™ Cold, Flu & Sore Throat For Ages 12 & Over MAXIMUM STRENGTH MUCUS RELIEF Cold, Flu & Sore Throat Acetaminophen Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Phenylephrine HCl - Nasal Decongestant Relieves Headache & Fever Relieves Nasal & Chest Congestion Thins & Loosens Mucus Controls Cough 20 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING SATISFACTION GUARANTEED OR YOUR MONEY BACK Manufactured For: Your Military Exchanges Distributed by: LNK International, Inc. Hauppauge, NY 11788 *This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX™ Cold, Flu & Sore Throat. 50844 ORG011361609 KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION Exchange Select 44-616 Exchange Select 44-616" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: nasal congestion sore throat headache minor aches and pains cough temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "13faf3ae-207f-4529-9493-0b3c18d9c8a9", "id": "6f9e89eb-5725-4709-854d-1273ddef7a90", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20130102", "inactive_ingredient": [ "Inactive Ingredients: Acacia gum, lactose, magnesium stearate, starch, sucrose." ], "purpose": [ "Reduces body odor and excessive perspiration" ], "keep_out_of_reach_of_children": [ "Keep this and all medication out of reach of children." ], "warnings": [ "Warning: If symptoms persist or worsen, consult a healthcare professional." ], "spl_product_data_elements": [ "DeodoRite Calc sulph, Carduus mar, Galium, Mag phos, Merc solub, Silicea, Acacia gum, lactose, magnesium stearate, starch, sucrose CALCIUM SULFATE ANHYDROUS CALCIUM CATION ACACIA LACTOSE MAGNESIUM STEARATE STARCH, CORN SUCROSE SILYBUM MARIANUM SEED SILYBUM MARIANUM SEED GALIUM APARINE GALIUM APARINE MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS SILICON DIOXIDE SILICON DIOXIDE white lactose tablet round white lactose tablet" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: Adults and Children 12+: Take 2 tablets 3 times daily. Children under 12: Take 1 tablet 3 times daily." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use." ], "storage_and_handling": [ "Tamper resistant for your protection. Use only if safety seal is intact." ], "information_for_patients": [ "The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com Distributed by Native Remedies, LLC 6531 Park of Commerce Blvd. Suite 160 Boca Raton, Fl 33487 Phone:+1.877.289.1235 International:+1.561.999.8857 Contains no artificial flavors or artificial colors. No gluten added." ], "package_label_principal_display_panel": [ "Bottle Label" ], "indications_and_usage": [ "Uses: Homeopathic remedy for relieving bad body odor from excessive perspiration." ], "set_id": "13fc6c4a-f37d-44df-96f3-c53726d40788", "id": "797bb695-f030-42e5-b44a-4d66947aa0e0", "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away." ], "active_ingredient": [ "Enter section text here" ] }, { "effective_time": "20130924", "inactive_ingredient": [ "Inactive Ingredients carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide." ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers. Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days Pregnancy/Breastfeeding If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or Comments? Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) Consumer Information What you should know about MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg / Acid Reducer (Please read all this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference) What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide. What symptoms do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg treat and prevent? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieves and prevents heartburn associated with acid indigestion and sour stomach. Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort. Excellent Safety Record The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications. MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free. How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? To relieve symptoms, swallow 1 tablet with a glass of water. To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours). MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor. How do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduces the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid. Tips for managing heartburn Do not lie flat or bend over soon after eating Do not eat late at night, or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose fitting clothing around your stomach Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers When should I see a doctor? Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast feeding , ask a health professional before use. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away. Questions or Comments? Call 1-800-706-5575 (Monday to Friday, 8:30 am – 5:00 pm Eastern Standard Time) Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, FL Canada M9L 1T9 33326 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 ran-150mg-otc-esophagus" ], "spl_product_data_elements": [ "Ranitidine Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE RANITIDINE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE TITANIUM DIOXIDE VANILLIN FERRIC OXIDE RED FERRIC OXIDE YELLOW" ], "ask_doctor": [ "Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and Children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) do not chew tablet children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "Pregnancy/Breastfeeding If pregnant or breastfeeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "Other Information do not use if bottle seal is open or torn store at 20° to 25°C (68° to 77°F) protect from light this product is sodium and sugar free" ], "do_not_use": [ "Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel OTC Medicine Maximum Strength Rantidine Tablets USP, 150 mg IMAGE LABEL" ], "indications_and_usage": [ "Use(s) Relieves heartburn associated with acid indigestion and sour stomach Prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages" ], "set_id": "14710d5d-16e8-48f8-9fd5-1530a087eb34", "id": "96b79fbb-56cb-4338-8c37-3150d381782e", "active_ingredient": [ "Active Ingredient(s) Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)" ] }, { "effective_time": "20150424", "inactive_ingredient": [ "Inactive Ingredients Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide." ], "purpose": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away." ], "warnings": [ "Warnings Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "when_using": [ "When using this product drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary." ], "questions": [ "Questions? Call 1-866-562-4597" ], "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride HYPROMELLOSES LACTOSE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL POVIDONE TITANIUM DIOXIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE White Barrel Shaped CTN;10" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other Information store between 20° to 25°C (68° to 77°F)", "Manufactured for PACK Pharmaceuticals, LLC Buffalo Grove, IL 60089, USA Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India" ], "package_label_principal_display_panel": [ "Cetirizine Hydrochloride Tablets 10 mg Container Label Blenheim Pharmacal, Inc. NDC 10544-670-30 Original Prescription Strength Cetirizine Hydrochloride Tablets 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets Allergy Indoor & Outdoor Allergies Label 10mg 30ct" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "147e91e6-0840-05ee-e054-00144ff8d46c", "id": "14b4967f-6f33-4ade-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active Ingredients Active Ingredients (in each tablet) Purpose Cetirizine HCl 10 mg..............................................................................................Antihistimine" ], "dosage_and_administration_table": [ "
Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever symptoms.
Adults 65 years and over Ask a doctor
Children under 6 years of age Ask a doctor
Consumers with liver or kidney disease Ask a doctor
" ] }, { "effective_time": "20130723", "inactive_ingredient": [ "INACTIVE INGREDIENTS croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Contains No Aspirin Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902" ], "spl_product_data_elements": [ "Arthritis Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE Capsule Shaped cor116" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date (Applicable only for Bottle Carton) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 66336-0233-XX EASY TO OPEN BOTTLE Use only as directed. See New Warnings Information Lasts up to 8 hours Arthritis Pain Relief Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) † Compare to the active ingredient of Tylenol ® Arthritis Pain † This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., The owner of the registered trademark Tylenol ® is the Tylenol Company. NDC 66336-0233-XX" ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "14a9db65-6d7b-4b06-ae03-93988ccc141d", "id": "8e39026d-40d6-4235-8422-08408281f3f6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age ask a doctor
" ] }, { "effective_time": "20121221", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton or pouch is open or torn see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "set_id": "14b0e72a-2cce-42d9-8f67-c750246dc3db", "id": "76d627af-8883-473c-8338-c8630a42c226", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "spl_product_data_elements": [ "Extra Strength Tylenol PM Acetaminophen and Diphenhydramine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine CARNAUBA WAX FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYSORBATE 80 POWDERED CELLULOSE PROPYLENE GLYCOL SHELLAC SODIUM CITRATE TITANIUM DIOXIDE light Blue Capsule shaped Tylenol;PM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts", "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Repackaged and distributed by: Lil' Drug Store Products, Inc. 1201 Continental Place NE, Cedar Rapids, IA 52402 1-877-507-6516 (M-F 8AM-4:30PM CST) www.lildrugstore.com" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 4 caplet Carton See New Warnings Information & Directions Extra Strength TYLENOL ® PM Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl Non-habit forming Caplets 4 CAPLETS Lil' Drug Store PRINCIPAL DISPLAY PANEL - 4 caplet Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ] }, { "effective_time": "20121002", "inactive_ingredient": [ "INACTIVE INGREDIENTS Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch" ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN White to Off-White RX526" ], "ask_doctor": [ "Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use If you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL * Compare to the active ingredient of Claritin ® NDC 15127-715-30 select brand ® NON-DROWSY ٭ Allergy Relief Loratadine Tablets USP, 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES RELIEF OF: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose 24 Hour Allergy Relief 30 Tablets ٭ When taken as directed. See Drug Facts Panel. Distributed by: SELECT BRAND DISTRIBUTORS 5069402/1008 This is the 30 count blister carton label for Select Brand Loratadine tablets." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "14c00a0a-3522-4f11-b409-8b1dcd18798e", "id": "73e2a4b3-c024-4b6a-8a92-519df6c3f202", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ] }, { "effective_time": "20111117", "inactive_ingredient": [ "Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate and Microcrystalline Cellulose. *This product is not manufactured or distributed by Pfizer Consumer Healthcare owner of the registered trademark Dramamine® Tablets. Manufactured by: CONTRACT PHARMACAL CORP. 135 Adams Ave., Hauppauge, NY 11788 USA / www.CPCHealth.com 02/08" ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions adults and children 12 years of age and over 1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours children 6 years to under 12 years of age ½ to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours children 2 years to under 6 years of age ¼ to ½ tablet every 6 to 8 hours, not to exceed 1 ½ tablets in 24 hours children under 2 years of age consult a doctor To prevent motion sickness, the first dose should be taken one half to one hour before starting activity. DO NOT EXCEED RECOMMENDED DOSE" ], "warnings": [ "Warnings Do not use in children under 2 years of age unless directed by a doctor" ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "spl_product_data_elements": [ "Dimenhydrinate Dimenhydrinate DIMENHYDRINATE DIMENHYDRINATE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE 1006;1006" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Other information: store at room temperature, USP Each tablet contains 29 mg of calcium" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "SPL UNCLASSIFIED *Compare to the active ingredient in Dramamine® Tablets Dimenhydrinate 50mg MOTION SICKNESS RELIEF for ADULTS and CHILDREN 100 Tablets DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts" ], "keep_out_of_reach_of_children_table": [ "
adults and children 12 years of age and over 1 to 2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours
children 6 years to under 12 years of age ½ to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours
children 2 years to under 6 years of age ¼ to ½ tablet every 6 to 8 hours, not to exceed 1 ½ tablets in 24 hours
children under 2 years of age consult a doctor
" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL c82df322-figure-01" ], "indications_and_usage": [ "Uses for prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness" ], "set_id": "14ccdb11-5706-4007-aa27-a60ef3f09ce7", "id": "c82df322-fce0-4bfa-b21b-a2e921611d81", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active Ingredient (in each tablet) Dimenhydrinate 50 mg" ] }, { "effective_time": "20130212", "purpose": [ "Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-570-8650" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information avoid excessive heat and humidity store between 15-30°C (59-86°F) do not use if pouch is torn or open see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains itching of the nose or throat itchy, watery eyes helps decongest sinus openings and passages" ], "set_id": "14d1f439-16a3-4fd8-949b-5b29d5b25d42", "id": "2eee76ce-e881-4ca7-b7d5-2dbf60dbff77", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, sodium lauryl sulphate, edetaet disodium, dioctyl sodium sulphosuccinate, polyvinylpyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide, yelllow iron oxide." ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "ConRx Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Chlorpheniramine maleate Chlorpheniramine Phenylephrine Hydrochloride Phenylephrine SILICON DIOXIDE SODIUM LAURYL SULFATE EDETATE DISODIUM DOCUSATE SODIUM POVIDONE K90 GELATIN STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 6000 SODIUM BENZOATE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW CRX" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • do not take more than directed ( see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours, do not take more than 8 tablets in 24 hours, children under 12 years, consult a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 2 Caplets × 50 Pouch Box See New Warnings Information & Directions Compare to the Active Ingredients in Tylenol ® Allergy* Multi-Symptom ConRx™ Allergy Sinus Sneezing - Runny Nose - Congestion Acetaminophen Headache Phenylephrine HCl Sinus Pressure/Nasal Congestion Chlorpheniramine Maleate Watery Eyes/Runny Nose TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in Tylenol ® Allergy* Multi-Symptom 50 Pouches of 2 Caplets Each Principal Display Panel - 2 Caplets × 50 Pouch Box" ], "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20101130", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains itching of the nose or throat itchy, watery eyes helps decongest sinus openings and passages" ], "set_id": "150f957a-b7fb-4f89-a421-6f2bc39b6849", "id": "9dfa0205-8228-4bba-905d-3f4662508946", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, potassium sorbate, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide, triacetin" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Tylenol Sinus and Allergy Severe acetaminophen, diphenhydramine Hydrochloride, and phenylephrine Hydrochloride acetaminophen acetaminophen diphenhydramine Hydrochloride diphenhydramine phenylephrine Hydrochloride phenylephrine anhydrous citric acid carnauba wax starch, corn D&C yellow NO. 10 aluminum oxide FD&C yellow NO. 6 hypromelloses ferrosoferric oxide magnesium stearate cellulose, microcrystalline potassium sorbate propylene glycol shellac sodium benzoate sodium citrate sodium starch glycolate type a potato sucralose titanium dioxide triacetin Light yellow TY;S;A;Severe" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-314-24 See New Warnings Information TYLENOL ® SINUS & ALLERGY SEVERE Alleviates Sinus Headache & Pain Acetaminophen Dries Runny Nose Alleviates Itchy, Watery Eyes Diphenhydramine Relieves Sinus Pressure Clears Nasal Congestion Phenylephrine HCl 24 Cool Burst ® CAPLETS PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20140819", "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive Ingredients: Lactose, Magnesium stearate" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children" ], "purpose": [ "PURPOSE Relieves Pain due to: • Overexertion • Bruises • Minor Injury" ], "warnings": [ "WARNINGS If pregnant or breast-feeding , ask a health professional before use. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Arnica + or any of its ingredients exists." ], "spl_product_data_elements": [ "BHI Arnica Plus ARNICA MONTANA ROOT ARNICA MONTANA ROOT ARNICA MONTANA ROOT LACTOSE BHI;O;M" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE Directions: At first sign of symptoms:Adults and children 4 years and older: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. Standard dosage: Adults and children 4 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. Allow tablets to dissolve completely in the mouth, do not swallow" ], "package_label_principal_display_panel": [ "image description Arnica + Tablet.jpg" ], "indications_and_usage": [ "INDICATIONS For the temporary relief of minor pain due to Overexertion Bruises Minor Injuries" ], "set_id": "1554e83c-b96a-4716-8aa0-b2baee4a2463", "id": "4a7e8c0e-c962-4491-aee9-b39e7d676e25", "active_ingredient": [ "ACTIVE INGREDIENTS Active Ingredients: Each tablet contains: *Arnica montana, radix 6X, 12X, 30X, 200X, 75 mg each. *Natural ingredients" ] }, { "effective_time": "20120127", "inactive_ingredient": [ "Inactive ingredients colloidal silica*, croscarmellose sodium, D&C Red #27*, dicalcium phosphate*, FD&C red #40*, FD&C yellow #6*, hypromellose*, lactose*, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze*, polyethylene glycol*, pregelatinized starch*, silicon dioxide*, stearic acid*, talc*, titanium dioxide*. * may contain" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product do not exceed recommended dosage if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor" ], "questions": [ "Questions or comments? 1-800-869-6970" ], "spl_product_data_elements": [ "Green Guard Allergy 2 Relief PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE D&C RED NO. 27 MAGNESIUM STEARATE SILICON DIOXIDE STARCH, CORN STEARIC ACID TALC pink ROUND G;55" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Phenylephrine HCl 5mg Purpose Nasal decongestant Uses Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure. Warnings Do not use If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage if nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor Stop use and ask a doctor if symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age Other information read all product information before using. contains FD&C yellow #6 (tartrazine) store at room temperature 59º-86º F (15º-30º C). tamper evident sealed packets. do not use any opened or torn packets Inactive ingredients colloidal silica*, croscarmellose sodium, D&C Red #27*, dicalcium phosphate*, FD&C red #40*, FD&C yellow #6*, hypromellose*, lactose*, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze*, polyethylene glycol*, pregelatinized starch*, silicon dioxide*, stearic acid*, talc*, titanium dioxide*. * may contain Questions or comments? 1-800-869-6970" ], "stop_use": [ "Stop use and ask a doctor if symptoms do not improve within 7 days or are accompanied by fever" ], "do_not_use": [ "Do not use If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "205R Green Guard Allergy 2 Relief Label Allergy 2 relief™ Pull To Open Phenylephrine HCl 5mg Fenilefrina 5mg Tabletas para el alivio de sintomas alergicos Temporarily relieves nasal congestion due to common cold, hay fever and other upper respiratory allergies. Green Guard® 50 Packets of 2 Tablets 100 Tablets Order #2230 Distributed by Green Guard®, St Louis, MO 63045 Principal Display Panel" ], "indications_and_usage": [ "Uses Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure." ], "set_id": "15df52d9-af28-4e36-92ef-16a14a5c581f", "id": "ee4f759b-7d51-4bc8-ae56-e361eca66be9", "active_ingredient": [ "Active ingredient (in each tablet) Phenylephrine HCl 5mg" ] }, { "questions_table": [ "
Amount Per Serving %Daily Value
Calories 10
Sugars 2g
Calcium 600mg 60%
Sodium 5mg (less than 1%)
Magnesium 2mg (less than 1%)
" ], "effective_time": "20141107", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, sorbitol, dextrose, sucrose, microcrystalline cellulose, magnesium stearate, natural and artificial flavors, adipic acid, corn starch, guar gum, maltodextrin, red 40 lake, blue 1 lake. Contains soy" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product • do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-800-897-7535 weekdays CALCIUM SUPPLEMENT USES: As a daily source of extra calcium. DIRECTIONS: Chew 2 tablets twice daily with a meal. Supplement Facts Serving Size: 2 Tablets Servings Per Container: 30 Amount Per Serving %Daily Value Calories 10 Sugars 2g Calcium 600mg 60% Sodium 5mg (less than 1%) Magnesium 2mg (less than 1%) Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 TUMS and SMOOTHIES are trademarks of the GlaxoSmithKline group of companies. www.tums.com" ], "spl_product_data_elements": [ "Tums calcium carbonate Tums Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SORBITOL DEXTROSE SUCROSE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE ADIPIC ACID STARCH, CORN GUAR GUM MALTODEXTRIN FD&C RED NO. 40 ALUMINUM OXIDE FD&C BLUE NO. 1 SOYBEAN mauve, peach, dark pink TUMS;SD Berry Fusion, citrus berry, orange passion, strawberry Tums Extra Strength calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SUCROSE STARCH, CORN TALC MINERAL OIL ADIPIC ACID SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 TUMS Assorted Fruit Flavor" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions chew 2 – 4 tablets as symptoms occur, or as directed by a doctor" ], "spl_unclassified_section": [ "Other information • for calcium/magnesium/sodium content see Supplement Facts • store below 25 o C (77 o F). Keep the container tightly closed." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0555-01 TUMS ® EXTRA STRENGTH 750 ANTACID ASSORTED FRUIT 8 Chewable TABLETS TUMS ® ANTACID / CALCIUM SUPPLEMENT Smoothies TM EXTRA STRENGTH 750 CALCIUM RICH SMOOTH DISSOLVE BERRY FUSION NATURALLY & ARTIFICIALLY FLAVORED PAREVE FREE TUMS ® 8ct Roll 60ct Bottle – Smoothies Berry Fusion 8ct Roll – EX Assorted Fruit ©2012 GlaxoSmithKline 102777PA Tums copack Smoothies Berry Fusion 60ct and Extra Strength Assorted Fruit 8ct carton" ], "indications_and_usage": [ "Uses relieves • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms" ], "set_id": "15eb7ac5-530c-46bf-add0-98a064287009", "id": "0ef73ab8-7bb4-426f-aff9-a6bc010f2a0e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (per tablet) Calcium carbonate USP 750 mg" ] }, { "effective_time": "20151016", "inactive_ingredient": [ "Inactive ingredients FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Mucus Relief Chest Guaifenesin GUAIFENESIN GUAIFENESIN FD&C BLUE NO. 1 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONES SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;532" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take with a full glass of water adults and children 12 years of age and over : 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years : do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 49035-555-11 Immediate-Release Mucus Relief Chest Guaifenesin 400 mg • Expectorant Relieves Chest Congestion Thins and Loosens Mucus QUALITY GUARANTEED 60 Tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0812D53211 Wal-Mart 44-532 Wal-Mart 44-532" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom mucus and make coughs more productive" ], "set_id": "161af4aa-328b-4a49-9354-cee2ba67db19", "id": "f56c5d22-5698-4017-b064-b3f864a78a03", "active_ingredient": [ "Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg" ] }, { "effective_time": "20111115", "inactive_ingredient": [ "Inactive ingredients: corn starch, croscarmellose sodium, D&C yellow # 10 aluminum lake 14-18%, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery" ], "questions": [ "Questions: To Report Adverse Drug Events Call 800-687-0176." ], "spl_product_data_elements": [ "Chlorpheniramine Maleate Chlorpheniramine Maleate Chlorpheniramine Maleate Chlorpheniramine STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE PH012" ], "ask_doctor": [ "Ask a doctor before use if you have, a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and older one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours children 6 to under 12 years of age 1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours children under 6 years of age consult a physician" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use" ], "storage_and_handling": [ "Other information Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing store at controlled room temperature 15 o -25 o C (59 o -77 o F) protect from excessive moisture" ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy nose or throat itchy watery eyes sneezing" ], "set_id": "168b94d6-95ef-4c2d-97bc-c3f0042fd82e", "id": "bfa490bf-965b-4d6d-94fe-5aef98ab6b09", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each tablet) Chlorpheniramine Maleate 4 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and older one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours
children 6 to under 12 years of age 1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
children under 6 years of age consult a physician
" ] } ] }