{ "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": "2026-05-14", "results": { "skip": 0, "limit": 100, "total": 117 } }, "results": [ { "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": "20140417", "inactive_ingredient": [ "Inactive Ingredients •aspartame (contains phenylalanine), carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol" ], "purpose": [ "Purpose Cough Suppressant, Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious." ], "when_using": [ "When using this product •do not exceed recommended dosage" ], "spl_product_data_elements": [ "Bentasil SUGAR FREE EUCALYPTUS SOFT Texture Menthol Eucalyptus MENTHOL MENTHOL EUCALYPTUS OIL EUCALYPTUS OIL ASPARTAME CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL PALM KERNEL OIL ACACIA MALTITOL SORBITOL XYLITOL Eucalyptus and Menthol Lozenge NONE Aqua" ], "ask_doctor": [ "Ask a doctor before use if you have •persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions •adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. •children under 5 years: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if •cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens" ], "spl_unclassified_section": [ "Other Information • Phenylketonurics: Contains Phenylalanine (1.3) mg per drop. •3.2 calories per drop" ], "package_label_principal_display_panel": [ "Product Label image description" ], "indications_and_usage": [ "Uses •for the temporary relief of minor sore throat •for the temporary relief of coughs due to a cold" ], "set_id": "008cf979-a632-419e-b4ae-2aa1f9831e7e", "id": "5069cb14-68e1-4acc-8015-b3f12ad448ef", "active_ingredient": [ "Active Ingredient Menthol 5.8mg Eucalyptus oil 5.7mg" ] }, { "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": "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": "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": "20151207", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Walgreens Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "0b64f82e-2370-43cc-9d55-dd95f79ac70a", "id": "2655a37a-6044-501b-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "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": "20150421", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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" ], "questions": [ "Questions or Comments? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "14ca3278-8f48-4a46-b30f-35c41c5d5240", "id": "a2d63bad-4e8e-4477-872a-750de9bc7f47", "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 packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 care professional before use. Keep out of reach of children. 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": [ "Rite Aid Daytime Severe Cold and Cough Relief Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "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 nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton RITE AID ® PHARMACY SEE NEW WARNINGS INFORMATION & DIRECTIONS * Compare to the active ingredients in Theraflu ® Severe Cold & Cough daytime severe cold & cough relief acetaminophen 650 mg dextromethorphan HBr 20 mg phenylephrine HCl 10 mg pain reliever/fever reducer cough suppressant & nasal decongestant relieves: nasal & sinus congestion cough body ache sore throat pain headache fever berry infused with menthol & green tea flavors 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20120518", "inactive_ingredient": [ "Inactive Ingredients Petrolatum, Cetyl Alcohol, Ozokerite, Isopropyl Myristate, Dimethicone, Flavor (Aroma), Aspartame, Cannabis Sativa Seed Extract, Squalane, Tocopheryl Acetate, Isopropylparaben, Butylparaben, Limonene, Citral." ], "warnings": [ "Warnings For external use only. Keep out of reach of children." ], "spl_product_data_elements": [ "Hempz Moisturizing Lip Balm Octinoxate, Oxybenzone Octinoxate Octinoxate Oxybenzone Oxybenzone Petrolatum Cetyl Alcohol Isopropyl Myristate DIMETHICONE Aspartame CANNABIS SATIVA SEED OIL Cannabis Sativa Seed Squalane Alpha-Tocopherol Acetate Isopropylparaben Isobutylparaben Butylparaben LIMONENE, (+/-)- Citral" ], "openfda": {}, "version": "22895", "dosage_and_administration": [ "Directions Apply to lips as needed. THC-Drug Free." ], "spl_unclassified_section": [ "SPL Unclassified Sold only in professional salons. Distributed by: Hemp Technologies, Division of PBIGroup, Inc. PO Box # 1449, Addison, TX 75001 800-851-4206 Made in U.S.A. (Europe) Leeds LS134LY UK +44(0) 113 255922 hempzproducts.com" ], "package_label_principal_display_panel": [ "image of tube" ], "set_id": "15374f1c-697c-476a-a1b8-774dee399f33", "id": "d22e3f31-347b-40bd-b661-d86b0f002258", "active_ingredient": [ "Active Ingredients Octinoxate 7.5%, Oxybenzone 2.5%" ] }, { "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 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 Claritin ® Reditabs ®† 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 Itchy Throat or Nose 1 0 Orally Disintegrating Tablets * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: AMERICAN SALES COMPANY 5080282/R0211 Compare to the active ingredient of Claritin ® RediTabs ®† CAREONE ® Original Prescription Strength CHILDREN'S 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 Itchy Throat or Nose 10 Orally Disintegrating Tablets * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: AMERICAN SALES COMPANY 5080281/R0211 This is the 10 count blister carton label for Careone Loratadine ODT, 10 mg. This is the bottle carton label for Careone 10 count Loratadine ODT, 10 mg (Claritin 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": "178d708e-6091-4357-9dec-acfeb0cadfb3", "id": "2362edeb-ac77-40c2-a066-757729e41e20", "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": "20091103", "spl_unclassified_section_table": [ "
Age Dose
adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily
children under 6 ask a doctor
consumers who have liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS artificial & natural flavor, aspartame, citric acid, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate" ], "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 use more than directed. Taking more than recommended 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 use more than directed. Taking more than recommended may cause drowsiness." ], "questions": [ "QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "spl_product_data_elements": [ "CHILDRENS DIMETAPP NON-DROWSY ALLERGY ODT loratadine loratadine loratadine white to off white flat faced round beveled tablet A;24 Flat minty flavor" ], "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", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "DIRECTIONS tablet melts in mouth. Can be taken with or without water. Age Dose adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor", "OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet store at 20-25ºC (68-77ºF) keep in a dry place" ], "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" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. Children’s Dimetapp ND Non-Drowsy* Allergy Loratadine Orally Disintegrating Tablet, 10mg, Antihistamine 24 Hr. Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itching of Nose & Throat 24 Hour COOL BLAST MELTS IN YOUR MOUTH 12 Orally Disintegrating Tablets *When taken as directed, see DRUG FACTS Panel. Visit our website at www.dimetapp.com Wyeth Distributed by: Wyeth Consumer Healthcare Madison, NJ 07940 EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN. Children's Dimetapp ND (Non-Drowsy) Allergy Packaging" ], "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": "1b139418-4836-abc9-de65-f78b38538f02", "id": "0f1d2f40-5352-3f1c-55c6-6d93c2ad2808", "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Loratadine 10 mg" ] }, { "effective_time": "20150129", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-800-ShopRite" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a heath care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "1e0d1d59-8856-4914-b4dd-9050ab8086a0", "id": "f11d78c0-2007-4c20-a664-7ebfca15d6e2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care professional before use. Keep out of reach of children. 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": [ "ShopRite Nighttime Flu Plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Diphenhydramine hydrochloride Diphenhydramine Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid D&C yellow no. 10 FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: Wakefern Food Corp. 5000 Riverside Drive Keasbey, NJ 08832" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton Compare to: Active Ingredients in Theraflu ® Nighttime Severe Cold & Cough See New Warnings Information & Directions ShopRite ® Nighttime FLU & SEVERE COLD & COUGH ACETAMINOPHEN Pain Reliever/Fever Reducer DIPHENHYDRAMINE HCl Antihistamine/Cough Suppressant PHENYLEPHRINE HCl Nasal Decongestant Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache, Fever Honey Lemon Infused with Chamomile & White Tea Flavor 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Nighttime Inactive Ingredient Acesulfame potassium, Aspartame, Caramel, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.", "Multi-Symptom Inactive Ingredient Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, Silicon dioxide, Sodium Citrate, Starch and Sucrose." ], "purpose": [ "Purpose Nighttime Uses - temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever.", "Purpose Multi-Symptom Uses - Temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Keep out of reach of children. 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." ], "warnings": [ "Nighttime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. 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 - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Multi-Symptom Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin redenning - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. 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 - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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": [ "Well at Walgreens Multi-Symptom Wal-Flu Severe Cold and Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr Walgreens Nighttime Wal-Flu Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon flavor Caramel color D and C Yellow 10 Walgreens Multi-Symptom Wal-Flu Severe Cold Green Tea and Honey Lemon Flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon Flavor Caramel color D and C Yellow No. 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "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 occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Nighttime Dosage and Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and older one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve content of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.", "Multi-Symptom Dosage & Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "information_for_patients": [ "Nighttime Information for Patients Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.", "Multi-Symptom Information for Patients Other information - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg. - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1. jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "set_id": "1f336dce-df94-4c93-b901-17efc0b899d7", "id": "267ace69-bb22-482f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "overdosage": [ "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.", "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." ], "active_ingredient": [ "Active Ingredients for Nighttime Wal-Flu Severe Cold and Cough Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.", "Active Ingredients for Multi-Symptom Wal-Flu Severe Cold Active ingredients (in each packet) Purpose Acetaminophen 500 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and older one packet
", "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ] }, { "effective_time": "20130226", "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 INGREDIENTS OF CLARITIN ® REDITABS ® Best Choice ® Brand Original Prescription Strength Non-Drowsy † Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg 24 Hour Allergy Relief ANTIHISTAMINE No Water Needed Indoor & Outdoor Allergies Melts in Your Mouth For Adults & Children six years & older! Relief of: Sneezing; Runny Nose Itchy, Watery Eyes; Itchy Throat or Nose 10 Orally Disintegrating Tablets † When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: VALU MERCHANDISERS, CO. 5079396/R0610 10's blister 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": "1fcc897d-bc89-4270-bf03-dc6c2abe1d18", "id": "a070a784-fcd5-4af5-9b1d-1cc63153843a", "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": "20120925", "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 OR COMMENTS? Call 1-888-SAFEWAY" ], "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 NDC 21130-527-69 Compare to Claritin ® RediTabs ® active ingredient † 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 Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose For Adults and Children Six Years and Older * When taken as directed. See Drug Facts Panel. 10 ORALLY DISINTEGRATING TABLETS SAFEWAY ™ DISTRIBUTED BY SAFEWAY INC. 5082800/R0212 This is the 10 count blister carton label for Safeway 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": "244e041f-20e2-4e38-ac6b-bf96f8724d5e", "id": "d5ec9af0-b2a0-47cd-a418-cfc00df2afd8", "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": "20120921", "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 ODT Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White flat faced beveled edge RC17 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 NDC 41250-527-31 Compare to Claritin ® Reditabs ® active ingredient ** meijer ™ Original Prescription Strength Non-Drowsy * 24 HOUR RELIEF Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg · Antihistamine For Adults and Children six years and older! No Water Needed · Melts in Your Mouth! Indoor & Outdoor Allergies For 24 Hour Relief of: sneezing; runny nose; itchy, watery eyes; itchy throat or nose * When taken as directed. See Drug Facts Panel. 30 ORALLY DISINTEGRATING TABLETS DIST.BY MEIJER DISTRIBUTION, INC. 5078746/R0410 NDC 41250-513-24 Compare to ALAVERT ® active ingredient ** meijer ™ Original Prescription Strength Non-Drowsy * 24 HOUR RELIEF Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg • Antihistamine For Adults and Children six years and older! Mint Flavored No Water Needed · Melts in Your Mouth! For 24 Hour Relief of: sneezing; runny nose; itchy, watery eyes; itchy throat or nose Indoor & Outdoor Allergies 24 ORALLY DISINTEGRATING TABLETS * When taken as directed. See Drug Facts Panel. DIST.BY MEIJER DISTRIBUTION, INC. 5078747/R0410 This is the 30 count blister carton label for Meijer Loratadine ODT, Claritin like. This is the 24 count blister carton label for Meijer Loratadine ODT (Alavert)." ], "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": "24961bee-132c-4347-a3f4-0518396999ea", "id": "f9612ddf-5bbc-4756-a195-4fd5547e7bee", "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": "20151120", "inactive_ingredient": [ "Inactive Ingredients pullulan, natural mint extract, sugar, menthol, licorice, aspartame" ], "purpose": [ "Purpose Treatment of chronic nicotinism" ], "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: in conjunction with another smoking cessation product; if you are taking prescription medication for depression or asthma; if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor or pharmacist before use if you have: heart disease or an irregular heartbeat; high blood pressure; stomach ulcers; diabetes; allergies to other medication Stop use and speak to a doctor if any of the following occur: mouth, teeth, or jaw problems, irregular heartbeat or palpitations; you develop symptoms of an allergic reaction (such as difficulty breathing or a rash)" ], "spl_product_data_elements": [ "TBX-Free cytisine SUCROSE MENTHOL LICORICE PULLULAN CYTISINE CYTISINE MINT ASPARTAME" ], "other_safety_information": [ "OTHER SAETY INFORMATION Protect from excessiv moisture and heat Store between 15º and 25º C (59º to 77 º F) QUESTIONS OR COMMENTS 1-800-965-1594" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Adults 18 years or over Begin using TBX-Free on your quit day It is important to complete treatment. If you feel you need to use TBX-Free to keep from smoking, talk to your health care provider." ], "package_label_principal_display_panel": [ "TBX LABEL" ], "indications_and_usage": [ "Use Smoking cessation treatment" ], "set_id": "24fdfded-5d47-07a4-e054-00144ff8d46c", "id": "24fdfded-5d48-07a4-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Cytisine 8mg" ] }, { "effective_time": "20151217", "purpose": [ "Purposes Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant" ], "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). Prompt 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 • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-877-932-7948" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information • each packet contains: potassium 10 mg and sodium 25 mg • phenylketonurics: contains phenylalanine 13 mg per packet • store at 20-25°C (68-77°F)" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever" ], "set_id": "26112a21-f2c3-4021-898b-a86d357a0a91", "id": "773eb167-6652-40fd-a664-9d5de77b233d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate" ], "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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. 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." ], "spl_product_data_elements": [ "equaline flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME SILICON DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE Light to dark" ], "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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "stop_use": [ "Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion gets worse or lasts more than 7 days • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • 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." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel compare to Theraflu® Nighttime Severe Cold & Cough active ingredients flu & severe cold & cough nighttime acetaminophen (pain reliever/fever reducer) diphenhydramine HCl (antihistamine/cough suppressant) phenylephrine HCl (nasal decongestant) relieves: nasal congestion cough runny nose sneezing body ache sore throat pain headache/fever SEE NEW WARNINGS honey lemon infused with white tea flavors 6 packets Equaline Flu & Severe Cold & Cough image 1 Equaline Flu & Severe Cold & Cough image 2" ] }, { "effective_time": "20151008", "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 CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101, BOCA RATON, FL 33431" ], "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": "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. • 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 Premier Value ® NDC 68016-527-31 Original Prescription Strength NON-DROWSY * 24 Hour Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg Allergy Relief Antihistamine Indoor & Outdoor Allergies No water needed. Melts in your mouth. Relief of: • Sneezing • Itchy, Watery Eyes • Runny Nose • Itchy Throat or Nose For Adults and Children six years and older! 30 ORALLY DISINTEGRATING TABLETS COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN ® REDITABS ®† * When taken as directed. See Drug Facts Panel. † 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 30 count blister carton label for Premier Value Loratadine ODT, USP 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": "26a7a473-3b88-4aa6-be56-da315e7556b6", "id": "ffe62d63-befe-4308-a676-12b3e179a32b", "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": "20120307", "spl_unclassified_section_table": [ "
Weeks 1 through 6 Weeks 7 through 9 Weeks 10 through 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
Online By Phone
Personalized 12-Week Plan immediately by mail
Buddy Brochure immediately by mail
Personal Wellness Assessment immediately
Week 2 Helpful Tips X
Week 3 Helpful Tips X by mail
Week 4 Helpful Tips X
Week 6 Helpful Tips X by mail
Week 9 Helpful Tips X
Week 12 Certificate of Accomplishment X by mail
Online Drug Database X
Daily Health News X
" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll-free 1-866-751-9303" ], "pregnancy_or_breast_feeding": [ "If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known." ], "storage_and_handling": [ "Other information each lozenge contains: sodium 15 mg Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge sugar alcohol content: 1 g mannitol per lozenge store at 20-25°C (68-77°F) keep vial closed and protect from light" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving associated with quitting smoking" ], "set_id": "26bfbdad-d67a-41b9-803d-967d438a2672", "id": "40855932-0f9c-4ee0-96a5-4512c6ba9d66", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg (nicotine)" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every1 to 2 hours 1 lozenge every2 to 4 hours 1 lozenge every4 to 8 hours
" ], "inactive_ingredient": [ "Inactive ingredients aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "warnings": [ "Warnings Enter section text here If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdoes such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "good sense nicotine Nicotine Polacrilex NICOTINE NICOTINE POLACRILIN ASPARTAME MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM L873" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User’s Guide for complete directions and other important information stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdoes such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat" ], "spl_unclassified_section": [ "Consumer Information Nicotine Polacrilex Lozenge 2 mg and 4 mg User's Guide How to Use Nicotine Polacrilex Lozenges and Tips to Help You Quit Smoking. Not for sale to those under 18 years of age. Proof of age required. Not for sale in vending machines or from any source where proof of age cannot be verified. PLANNING YOUR SUCCESS 1) The key to accomplishing anything important is commitment. When it comes to quitting smoking, that is especially true. Nicotine Polacrilex Lozenges can help if you really want to quit. Nicotine Polacrilex Lozenges help reduce withdrawal symptoms including nicotine craving associated with quitting smoking. 2) Your chances of staying off cigarettes are much better if you start with at least 9 Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on a regular schedule (as outlined in this User's Guide). 3) Stop smoking completely when you start using Nicotine Polacrilex Lozenges. Even a single cigarette is likely to put you right back to square one. 4) This User's Guide outlines a 12-week plan for Nicotine Polacrilex Lozenges. Even though you may feel confident about your non-smoking status after a few weeks, it's important to stick with the plan to help you remain smoke free. 5) Nicotine Polacrilex Lozenges work best when used together with a support plan. 6) After the first six weeks, start using fewer Nicotine Polacrilex Lozenges, as directed in the instructions, so you can become smoke-and nicotine-free by the end of the 12 week plan. 7) If you have questions about using Nicotine Polacrilex Lozenges, please talk to your pharmacist, family doctor, or call toll-free 1-866-751-9303. YES! YOU WANT TO QUIT. Wonderful. You've made the most important decision of all, to stop smoking. And by choosing Nicotine Polacrilex Lozenges to help you, you're starting on the right path. Now remember, using Nicotine Polacrilex Lozenges doesn't just mean taking a Nicotine Polacrilex Lozenge. It means setting and following a program like the one we suggest in this User's Guide. Your own success depends on your effort, your level of addiction to tobacco, and your commitment to following your program. LET'S FACE IT. Quitting smoking isn't easy! You or someone you know may have tried unsuccessfully. That's okay. It's hard to stop smoking the first time you try. The important part is to learn from your previous attempts, consider what went wrong and keep trying to quit until you succeed. Look to this User's Guide for support as you undergo this terrific task. The guide includes important information on how to use Nicotine Polacrilex Lozenges and also gives you tips to help you stop smoking. Refer back to it often for advice, answers, and encouragement to help you stay on track. GET MOTIVATED. STAY MOTIVATED. Everyone has a reason for quitting–whether you're concerned about your health, your appearance, family or peer pressure, or the effect of secondhand smoke on your loved ones–all of the above, or something else entirely. Whatever your reasons, write them down. There's a wallet card inside the back cover of this User's Guide. Write your reasons on the card and carry it with you. When you have an urge to smoke or experience a difficult moment it can help you focus on your reasons for quitting. Lots of people quit with a co-worker, spouse or friend and use them as a quitting buddy. You can help each other out by providing extra encouragement in tough moments. There may be support groups in your area for people trying to quit. Call your local chapter of the American Lung Association, American Cancer Society or American Heart Association for further information. Toll free phone numbers are printed on the wallet card on the back cover of this User's Guide. UNDERSTANDING THE DOUBLE-EDGED SWORD. Smoking has two addictive components, a physical and a mental need for the nicotine in tobacco. You need to conquer both to succeed. Nicotine Polacrilex Lozenges can ease your physical nicotine addiction. But your readiness and resolve are necessary to help overcome the mental side of your cigarette dependence. So once you're ready, it's time to begin. But first, read and consider the following important warnings. IMPORTANT WARNINGS This product is only for those who want to stop smoking. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products. Ask a doctor before use if you have a sodium restricted diet heart disease, recent heart attack or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcers or diabetes. Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away. YOU’RE READY TO START. Okay, you're ready. To become a non-smoker, start today. Now before you do anything else, you have a bit of planning to do. Read this User's Guide all the way through. You want to make sure you bought the right dose to start. If you typically smoke your first cigarette within 30 minutes of waking up use the 4mg Nicotine Polacrilex Lozenges. If you smoke your first cigarette more than 30 minutes after waking up use the 2mg Nicotine Polacrilex Lozenges. Next, plan your quitting schedule. Get a calendar to follow your progress and mark the following four important dates (see the stickers in the middle of this booklet). THE PROGRAM STEP 1. (Weeks 1-6). Starting on your quit date it's best to use at least 9 Nicotine Polacrilex Lozenges each day, one every 1 - 2 hours. First choose the day you plan to quit (make it soon). Place the Step 1 sticker on this date. That's the day you will stop smoking cigarettes completely and start using Nicotine Polacrilex Lozenges to calm your cravings for nicotine and help you stay smoke free. Prior to the quit date, get rid of all your cigarettes to remove temptations and make it more difficult to start smoking again. Use a Nicotine Polacrilex Lozenge every 1 to 2 hours and at least 9 lozenges each day for the first 6 weeks to help prevent unexpected cravings and improve your chances of quitting. These aren't ordinary lozenges. Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow the lozenge. You may feel a warm or tingling sensation. Occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 to 30 minutes). Remember to read the instructions on page 9 before you take your first Nicotine Polacrilex Lozenge. STEP 2. (The next three weeks, that is weeks 7-9). At the beginning of week 7 start using fewer Nicotine Polacrilex Lozenges, one every 2-4 hours. After six weeks, you should wait a little longer between lozenges, one lozenge every two to four hours. This will help you gradually use fewer Nicotine Polacrilex Lozenges. Put the Step 2 sticker on the first day of week 7 to help remind you when to start reducing the number of Nicotine Polacrilex Lozenges you take. STEP 3. (The last three weeks, that is weeks 10-12). At the beginning of week 10, reduce Nicotine Polacrilex Lozenge use even further, one every 4-8 hours. At the beginning of week 10 further decrease the number of Nicotine Polacrilex Lozenges you use each day to reduce the amount of nicotine you get. You should do this by using one lozenge every 4 to 8 hours. Put the Step 3 sticker on the first day of week 10 so you know when you should be starting this last step to becoming smoke and nicotine-free. END. At the end of week 12 stop using Nicotine Polacrilex Lozenges to become both cigarette and nicotine-free. Put the 'EX-SMOKER' sticker on your calendar on the date 12 weeks after the day you stopped smoking and started using Nicotine Polacrilex Lozenges. You should not use Nicotine Polacrilex Lozenges beyond this date. BE PREPARED. Since smoking is an addiction, it is hard to quit. Even after you stop, there will be times when you WANT a cigarette, sometimes strongly. (See also section on “Challenges To Watch For”). The best defense is to be prepared. Plan now for handling tough times so you don't give in. For example: think about situations when you usually get a craving for cigarettes or where you think you might experience strong cravings. Try to avoid these situations where you can (for example, avoid spending time with smokers, or drinking alcohol, if those things tempt you to smoke). Change your habits. For example, take your coffee break somewhere else. Take a walk. In other words, break the association between your usual habits and cigarettes. If you do encounter a situation where you feel a strong craving, fight it! Take a break from the situation; keep yourself busy or distracted with other activities. Remind yourself why you want to quit, and above all, remind yourself that having “just one” really will hurt your goal of quitting! To prepare for tough situations, assemble a “survival package” – items that can keep you distracted in case you get a craving. For example, you may include cinnamon gum or hard candy, relaxing music, and things to keep your hands busy like a smooth stone, paper clips, or a rubber ball. Track your progress as you quit. Keep a journal. Write down how many pieces of Nicotine Polacrilex Lozenges you use each day. Note if and when you get a craving. If you slip and have a cigarette, don't give up. Stop smoking again and get back on your program with Nicotine Polacrilex Lozenges. Establish your support network. Keep friends' and family members' phone numbers ready to get the moral support you need. Before quitting, ask friends and family to support and encourage you. Think of specific ways they can help. Reward yourself. Set aside little gifts to yourself such as a CD or video, which you can earn by overcoming difficult hurdles. HOW Nicotine Polacrilex LOZENGES WORK. Nicotine Polacrilex Lozenges are a form of Nicotine Replacement Therapy. They deliver nicotine to your body, temporarily relieving craving and nicotine withdrawal symptoms when you quit smoking. But unlike cigarettes, Nicotine Polacrilex Lozenges deliver a lower, steady level of nicotine to your blood. When used as directed, Nicotine Polacrilex Lozenges help you regulate, control, and gradually reduce your body's craving for nicotine. The good news is that Nicotine Polacrilex Lozenges contain no tar or carbon monoxide, and therefore don't present the same medical risks as cigarettes. However, the lozenges still deliver nicotine, the addictive ingredient in cigarettes. And for some people the nicotine in Nicotine Polacrilex Lozenges can occasionally cause mouth or throat irritation, headaches, nausea, hiccups, upset stomach or dizziness. USING Nicotine Polacrilex LOZENGES PROPERLY. Remember, Nicotine Polacrilex Lozenges aren't like ordinary lozenges such as cough drops. This lozenge is designed to deliver nicotine into your system through the lining of your mouth, not in your stomach like most other medicines. It is important to minimize swallowing the dissolved medicine in these lozenges so that it can be properly absorbed in your mouth. Do not use more than one lozenge at a time, or many lozenges one after another since this can cause hiccups, heartburn, nausea or other side effects. Read all the following instructions before using Nicotine Polacrilex Lozenges. Refer to them often to make sure you're using Nicotine Polacrilex Lozenges correctly. IMPORTANT: Don't worry or give up if you do not like the taste of the lozenge at first. Nicotine Polacrilex Lozenges are a medication, not a candy. Most people get used to the taste after a day or two. Remember, staying with the plan will help you quit. Stop smoking completely before you start using Nicotine Polacrilex Lozenges. 1) Remove the Nicotine Polacrilex Lozenge from the QuitTube®. Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow the lozenge. You may feel a warm or tingling sensation. 2) Occasionally move the lozenge from one side of your mouth to the other side until completely dissolved (about 20-30 minutes). To reduce cravings or urges to smoke and other withdrawal symptoms, use Nicotine Polacrilex Lozenges according to the following dosage schedule. Weeks 1 through 6 Weeks 7 through 9 Weeks 10 through 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. Stop using the lozenge at the end of 12 weeks (3 months). FOR THE BEST CHANCE OF QUITTING, use Nicotine Polacrilex Lozenges on a regular schedule, using at least 9 lozenges a day during the first 6 weeks. That will help your body better adjust to the lack of cigarettes and better help prevent cravings. Some people may need more lozenges to reduce their cravings. Do not exceed the recommended maximum daily dosage of 20 lozenges per day. Do not continuously use one lozenge after another, since this may cause you hiccups, heartburn, nausea or other side effects. Do not eat or drink 15 minutes before using or while the lozenge is in your mouth. CUTTING BACK ON YOUR Nicotine Polacrilex LOZENGE USAGE. The whole reason for using Nicotine Polacrilex Lozenges is to decrease and slowly eliminate your need for nicotine, while you control cravings. So, as the above schedule indicates, you should gradually reduce the amount of Nicotine Polacrilex Lozenges you take per day. Some people find it easier to reduce by substituting ordinary sweets or sugar free candy for some of the Nicotine Polacrilex Lozenges they would normally use. As time goes on, you can increase the number of pieces of candy as you further reduce your use of Nicotine Polacrilex Lozenges. Stop using Nicotine Polacrilex Lozenge at the end of week 12. If you still feel the need to use Nicotine Polacrilex Lozenge after week 12, talk with your doctor. MAKE QUITTING EASIER ON YOURSELF. Soon after your quit date, parties, bars, celebrations, and socializing may all tempt you to smoke. Please remember these tips to help you resist those urges and stay smoke-free. The Day You Quit Smoking: Look to your family and friends for support. Let them know what to do or avoid doing to help you quit. Throw away ALL cigarettes, ashtrays, matches, lighters. You don't need them. You don't want them and you want to make it difficult to go back. Keep yourself occupied. Take a walk. See a movie. See friends. Do anything to keep your mind off cigarettes. Calculate all the money you'll save by not buying cigarettes. Probably well over $1,000 a year! $1,000 a year? Think of what you can spend it on! Know what situations are going to make you want to smoke. Plan now how you'll avoid them or deal with them so you don't smoke. Keep Nicotine Polacrilex Lozenges next to your bed so you're prepared when you get up. A lot of people get cravings first thing in the morning. Make an appointment to see your dentist and get the tobacco stains cleaned off. While you're getting rid of the evidence of cigarettes in the house, do the same for your teeth. Have clothes or drapes that smell of smoking cleaned. Now that your house is smoke-free, try to spend most of your time in smoke-free environments. If you usually smoked with coffee or alcohol, try to keep away from them for now. Remember you are also trying to break a habit. Smoking is a “hands-on” habit. So use something else to occupy your hands: a rubber band or a pen. Now's a good time to get active. Find activities to take your mind off cigarettes and relax. Take up jogging, swimming, or walking. Don't stress out about gaining weight. Dieting now may weaken your efforts to quit smoking. Eat sensibly and exercise daily; drink large quantities of water and fruit juices; this can help your chances of staying smoke-free. Laugh. Watch a sitcom. Read a comic book. It really helps. REMEMBER: Urges to smoke are temporary. They'll pass, even if you don't smoke. WHAT YOU CAN EXPECT. As you are successful at staying smoke-free, initially you will probably notice a few of the following typical withdrawal symptoms, so don't be surprised. Use of Nicotine Polacrilex Lozenges reduces these symptoms, but may not eliminate them entirely. They will go away with time. Stay focused on your goal of becoming an ex-smoker. Research shows that if you manage to avoid all smoking in the first week (that means not having a single puff), your chances of success increase dramatically. The First Few Days. You may feel nervous or irritable or have difficulty concentrating during the first few days after you quit smoking. Your body needs time to regain balance. Initially, you might feel a little out of sorts, get headaches, feel light-headed, or have trouble sleeping. Your smoker’s cough may get worse before it improves. But fear not, it’s a positive sign. Coughing helps clean your lungs of the tar residue you got from smoking. After A Couple Of Weeks. Your confidence and ability to cope with urges to smoke should be getting stronger. But don't be over-confident and think you can smoke just one cigarette. Even now, having even a single puff can lead to a return to smoking cigarettes regularly. Be prepared and remember why you wanted to stop smoking. Have you noticed that your sense of taste and smell has improved? You are probably coughing less and finding it easier to breathe. You've also probably noticed your withdrawal symptoms are subsiding (though don't worry if they're still there: they last longer for some people). These are all positive signs that your body is getting used to your success at stopping smoking. By The End Of The First Month. You are less likely to have cravings for cigarettes as often. However sudden cravings may still happen, and when they do, be on your guard, as they can be strong and seem to come out of the blue. Be prepared for these challenging times. The key is do what you can so these unexpected cravings can't beat you. Keep focused on the ways non-smokers are more attractive than smokers. Their breath smells better. Their clothes and hair are fresher. Their teeth are cleaner and brighter. Their skin is less likely to wrinkle. Not smoking around children and your friends is also healthier for them too. What If You Do Slip And Smoke? “What if I relapse?” One cigarette is a slip-up, but it's not the end of the quit effort. Everybody slips at something. The key is this: forgive yourself and stop at that one cigarette. Don't let this slip ruin your good intentions, keep at your quit attempt. So, throw out your cigarettes and continue with your quit attempt, keeping in mind what went wrong and led to the slip. If you do go back to smoking, certainly don't throw out your Nicotine Polacrilex Lozenges. Keep them for the next time you're ready to quit. In fact research says that even if you are back to smoking regularly the best thing you can do is learn and try again. Try to understand the reason you had those cigarettes that made you slip. That’s important, because now you can plan better to deal with these moments next time. It’s true you stumbled, but don’t think of yourself as having failed. Encourage yourself by treating the last attempt as a learning experience, even a “trial run” for the real thing. Take a look at the usage instructions and check that you used the Nicotine Polacrilex Lozenges correctly and for the full 12 weeks of the program. When you try again make sure you use enough and the right way. That way you’ll be best equipped to deal with the unexpected cravings. Don’t forget; quitting isn't easy and it takes practice to do anything. Stopping smoking is no different. YOU’VE MADE IT. Once your twelve week quitting program is over, you’ve taken your last Nicotine Polacrilex Lozenge. Now you are both cigarette and nicotine-free. Get up and give yourself a standing ovation. We mean it. Do you realize that you have just done a really difficult thing? Now’s a good time to think back on the process. Think of all your reasons for quitting smoking. Think of your goals. Think of how they’re going to be a reality now. Think of what you’re going to do with your newly liberated cigarette money. The places you can now go smoke-free. Think of the extra time you may have added to your life and what you can do with it. And although you may still experience the occasional temptation, and cigarettes still want you back, think positively. Think forward. And consider yourself a proud non-smoker. FREQUENTLY ASKED QUESTIONS. 1. When I stop smoking and start using Nicotine Polacrilex Lozenges how will I feel? Nicotine Polacrilex Lozenges help reduce cravings, but be prepared for some nicotine withdrawal symptoms. After you stop smoking they can begin almost at once and are normally at their strongest during the first three or four days. For some people, any of the following may occur: unexpected craving or urges for cigarettes anxiety, irritability, restlessness, mood changes, nervousness drowsiness trouble concentrating increased appetite and weight gain headaches, muscular pain, constipation, fatigue Nicotine Polacrilex Lozenges are designed to reduce the craving for nicotine you used to satisfy with cigarettes. Nicotine Polacrilex Lozenges can also help provide relief from other withdrawal symptoms such as irritability and nervousness. 2. Are Nicotine Polacrilex Lozenges just swapping one type of nicotine addiction for another? Nicotine Polacrilex Lozenges do contain nicotine, however there is probably less nicotine in your daily dose of lozenges than in your cigarettes. Nicotine Polacrilex Lozenges give you enough nicotine to help you combat the physical withdrawal symptoms so you can cope with the mental side of stopping smoking. Also, since the nicotine from the lozenges goes into your bloodstream more slowly, it produces less of the effects of nicotine that people find rewarding. In fact, when used as directed in the 12 week program, Nicotine Polacrilex Lozenges gradually wean you off your dependence for both nicotine and cigarettes. Remember, don't use Nicotine Polacrilex Lozenges together with nicotine patches or other nicotine containing products. 3. Can Nicotine Polacrilex Lozenges do any harm? Some people with conditions like heart disease or people taking prescription medicine for asthma or depression should not use this product without talking to their doctor - check the IMPORTANT WARNINGS on pages 3 and 4. You may also experience side effects such as hiccups, mouth or throat irritation, heartburn or other stomach problems such as nausea especially if Nicotine Polacrilex Lozenges are chewed or swallowed. In any case, Nicotine Polacrilex Lozenges do not contain the tar, carbon monoxide, and other toxins present in cigarette smoke. 4. Will I put on weight? In the first couple of months after quitting smoking, some people do put on a few pounds. But think of it this way. Overall, you’ll be healthier and look better. You can always tackle your weight by changing your diet and increasing the amount you exercise once you have gotten through the difficult part of stopping smoking. 5. Does taking Nicotine Polacrilex Lozenges cost more than smoking? If you normally smoke a pack and a half a day, your total cost of using Nicotine Polacrilex Lozenges during the 12-week period should be less than smoking. But guess what? After you’ve finished the Nicotine Polacrilex Lozenge program all that money you used to spend on cigarettes is now savings. And think of the health issues you’ll hopefully be able to avoid. 6. What if I have a cigarette and start smoking? Don't panic. First, don't think badly of yourself. Throw away your cigarettes and forgive yourself. Then think about what went wrong and get back on track. In fact people who have already tried to stop smoking are more likely to be successful the next time. CHALLENGES TO WATCH FOR. Once you quit smoking, you are likely to experience periodic, and sometimes intense, temptations to smoke. Certain situations present special challenges. Some common ones include: Stress and upset. When you are feeling stressed or upset, you may think a cigarette will make everything better. It won’t. Find other ways to relax and unwind. The blues. You may be especially vulnerable when you feel bored or blue. Remember that having a cigarette will just make you feel worse. Smoking cues. Seeing cigarettes or watching other people smoke can trigger temptation. Remember that you choose not to smoke anymore. Alcohol. Drinking and smoking seem to go together, and alcoholic beverages may weaken your resolve, making drinking dangerous to your quit effort. Avoid drinking early in your quit effort, and try to drink with non-smokers. Automatic slips. Sometimes you may find yourself preparing to smoke without even realizing it. Watch out for those moments when your hand seems to ‘automatically’ reach for a cigarette. Watch out for these situations: they can trigger a relapse. You probably know which one(s) are most dangerous for you; plan ahead to deal with the situation effectively. Always remember that you’re trying to break a habit, and the most important thing is to do something to combat the urge in these situations. COPING AFTER QUITTING. The key to staying smoke-free is to prepare for and cope with challenges as they occur. If you find yourself tempted to smoke, do something! Here are some things to consider. Escape. Leave the situation, even for a few minutes. Most temptations don’t last long. Distract yourself. Get your mind off smoking. Think of something else or get busy with something. Relax. Don't let stress get to you. Think of pleasant relaxing things; breathe slowly and regularly. Let the stress drain out of you. Talk yourself out of it. What you say to yourself matters. So, remind yourself how important it is for you to quit; remind yourself you can't have just one; or just command yourself to STOP. PACKAGED BY Perrigo® ALLEGAN, MI 49010 U.S.A. www.perrigo.com WALLET CARD My most important reasons to quit smoking are: WHERE TO CALL FOR HELP: American Lung Association 1-800-586-4872 American Cancer Society 1-800-227-2345 American Heart Association 1-800-242-8721 Quitting Buddy or Friend who has Quit Free Personalized Plan Begin Right Now! Having a plan will help you in your efforts to stop smoking. We can help! Follow the simple steps on the next page to receive your valuable personalized Smoke Free Habits plan and many other stop smoking tools and resources. Your Personal Enrollment Code XXXXXX-X How To Enroll Stopping smoking involves breaking your physical addiction and changing your behavior. You will use Nicotine Polacrilex Lozenges to help break your physical addiction, while your free personalized plan will help you develop healthier behaviors. To enroll: Go online to www.SmokeFreeHabits.com Enter your Personal Enrollment Code and the first five digits of the UPC number from the box. Answer the questions about yourself. Print your personalized plan. (If you don't have access to the Internet, you can call 1-866-751-9303, answer questions, and your plan will be mailed to you in a few days.) What You Will Receive Here are the free tools and resources that you will receive based on how you sign up for the program: Online By Phone Personalized 12-Week Plan immediately by mail Buddy Brochure immediately by mail Personal Wellness Assessment immediately Week 2 Helpful Tips X Week 3 Helpful Tips X by mail Week 4 Helpful Tips X Week 6 Helpful Tips X by mail Week 9 Helpful Tips X Week 12 Certificate of Accomplishment X by mail Online Drug Database X Daily Health News X Tips To Get Started 1. Follow your personalized Smoke Free Habits support plan. 2. Be sure to use Nicotine Polacrilex Lozenges as directed. 3. Throw away all of your cigarettes, lighters, and ashtrays. 4. You may feel urges to smoke, but they usually pass in 2-3 minutes. When you feel an urge, do something else. Take deep breaths and let them out slowly. Drink a glass of water. 5. Carry things to put in your mouth, like gum, hard candy or toothpicks. 6. Be active. Take a walk with a friend, ride your bike, walk the dog, play tennis. 7. Go to places where you are not allowed to smoke, like the movies or the mall. Try to steer clear of places where you usually smoked, like a break room at work or a favorite bar. 8. Ask friends or family for support whenever you need it. Place these stickers on your calendar: At the Beginning of Week #1 (Quit Date) At the Beginning of Week #7 Place these stickers on your calendar: At the Beginning of Week #10 12 Weeks After Quit Date Smoke Free Habits.com image Step 1 image Step 2 image Step 3 image 12 Weeks After Quit Date image" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68258-7992-07 NDC 68258-7992-07" ] }, { "effective_time": "20151229", "inactive_ingredient": [ "Inactive ingredients aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate." ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately." ], "warnings": [ "Warnings Do not use in children under 12 years of age unless directed by a 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 Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers. When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution 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 the poison control center immediately." ], "when_using": [ "When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-645-2158" ], "spl_product_data_elements": [ "Rugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC) Meclizine HCl ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM SULFATE SUCROSE TRICALCIUM PHOSPHATE MECLIZINE HYDROCHLORIDE MECLIZINE Biconvex Uncoated Tablet with Bisect 21G" ], "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" ], "other_safety_information": [ "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Dosage should be taken one hour before travel starts Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor Children under 12 years: do not give this product 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." ], "spl_unclassified_section": [ "Other information Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet store at room temperature" ], "do_not_use": [ "Do not use in children under 12 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting or dizziness due to motion sickness" ], "set_id": "280dc4d4-7773-3c13-e054-00144ff8d46c", "id": "280dc4d4-7774-3c13-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each chewable tablet) Meclizine HCl USP 25 mg" ] }, { "effective_time": "20130228", "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, aspartame, flavors, sodium bicarbonate, sucralose, yellow no 6." ], "purpose": [ "Purpose Fiber therapy for regularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have • a sudden change in bowel habits persisting for 2 weeks • abdominal pain, nausea or vomiting Stop use and ask a doctor if • constipation lasts more than 7 days • rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "CVS Natural Fiber Effervescent Psyllium Husk Psyllium Husk Psyllium Husk aspartame citric acid monohydrate FD&C Yellow No. 6 SODIUM BICARBONATE SUCRALOSE" ], "ask_doctor": [ "Ask a doctor before use if you have • a sudden change in bowel habits persisting for 2 weeks • abdominal pain, nausea or vomiting" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Put one packet into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults 12 yrs. & older: 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. Bulk forming fibers, like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. New Users Start with 1 dose per day; gradually increase to 3 doses per day as necessary." ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: CVS Pharmacy, Inc. One CVS Drive, Woonsocket RI 02895 CVS.com 1-800-SHOP CVS" ], "stop_use": [ "Stop use and ask a doctor if • constipation lasts more than 7 days • rectal bleeding occurs These may be signs of a serious condition." ], "storage_and_handling": [ "Other information • each packet contains: potassium 30 mg; sodium 194.0 mg • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 29.0 mg per teaspoon • store at room temperature tightly closed to protect from humidity • do not use if printed package is torn or punctured • contains a 100% natural, therapeutic fiber" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Natural Daily Fiber Effervescent Smooth Dissolving 100% Natural Psyllium Husk Fiber Supplement Compare to the active ingredient in Metamucil ® MultiHealth Fiber Sugar Free Therapy for regularity as part of a healthy lifestyle Promotes digestive health Helps lower cholesterol to promote heart health Orange Naturally and Artificially Flavored 30 Packets CVS Daily Fiber Effervescent" ], "indications_and_usage": [ "Uses • for relief of occasional constipation (irregularity)" ], "set_id": "280eafc2-bfdf-4bce-a24c-c55b07ff9d87", "id": "280eafc2-bfdf-4bce-a24c-c55b07ff9d87", "active_ingredient": [ "Active ingredient (in each PACKET) Psyllium husk approximately 3.4 g" ], "dosage_and_administration_table": [ "
Adults 12 yrs. & older: 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours.
" ] }, { "effective_time": "20150504", "inactive_ingredient": [ "Inactive ingredients aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning : This product contains acetaminophen. Severe liver damage may occur if ■ your child takes more than 5 doses in 24 hours ■ taken 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 Ask a Doctor before use if your child has liver disease Ask a Doctor/Pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050 Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms. Directions ■ this product does not contain directions or complete warnings for adult use ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age. Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 Age (yrs) Under 2 2-3 4-5 6-8 9-10 11 Tablets Consult a doctor 2 3 4 5 6 Other information ■ Phenylketonurics: contains phenylalanine 2.8 mg per tablet ■ store at room temperature ■ protect from excessive moisture ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose." ], "when_using": [ "When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems" ], "spl_product_data_elements": [ "Children Acetaminophen Children Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ASPARTAME CROSCARMELLOSE SODIUM D&C RED NO. 7 MANNITOL AZ023" ], "ask_doctor": [ "Ask a Doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ■ this product does not contain directions or complete warnings for adult use ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age. Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 Age (yrs) Under 2 2-3 4-5 6-8 9-10 11 Tablets Consult a doctor 2 3 4 5 6" ], "stop_use": [ "Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050" ], "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" ], "package_label_principal_display_panel": [ "DISPLAY PANEL AZPChildAPAPFR30.jpg" ], "indications_and_usage": [ "USES Temporary relief of minor aches and pains associated with ■ common cold and flu ■ headache ■ toothache ■ sore throat ■ immunizations ■ and reduction of fever" ], "set_id": "29d01244-7724-427c-ab1a-26227bb8f3dd", "id": "4f9c124d-ad7d-4482-8fec-23048e6452ba", "ask_doctor_or_pharmacist": [ "Ask a Doctor/Pharmacist before use if you are taking the blood thinning drug warfarin" ], "warnings_table": [ "
Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95
Age (yrs) Under 2 2-3 4-5 6-8 9-10 11
Tablets Consult a doctor 2 3 4 5 6
" ], "active_ingredient": [ "" ], "dosage_and_administration_table": [ "
Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95
Age (yrs) Under 2 2-3 4-5 6-8 9-10 11
Tablets Consult a doctor 2 3 4 5 6
" ] }, { "effective_time": "20120814", "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.sunmarkbrand.com" ], "spl_product_data_elements": [ "Sunmark Loratadine ODT Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White flat faced beveled edge RC17 Sunmark 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": "2", "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 sunmark ® NDC 49348-930-01 allergy relief 24 HOUR loratadine Orally Disintegrating Tablets, 10 mg Antihistamine For adults and children six years and older Indoor & Outdoor Allergies Non-drowsy * Relief of sneezing; runny nose; itchy, watery eyes; itchy throat or nose MELTS IN YOUR MOUTH 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. sunmark ® NDC 49348-929-04 allergy relief 24 HOUR Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine For adults and children six years and older Indoor & Outdoor Allergies Non-drowsy * Relief of sneezing; runny nose; itchy, watery eyes; itching of nose & throat MELTS IN YOUR MOUTH 24 ORALLY DISINTEGRATING TABLETS * When taken as directed. See Drug Facts Panel. COMPARE TO ALAVERT ® ACTIVE INGREDIENT † † The product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Alavert ® . This is the 10 count blister carton label for Sunmark Loratadine ODT, 10 mg. This is the 24 count blister carton label for Sunmark Loratadine ODT (Alavert)." ], "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": "2aa10bc8-4d85-49c8-ad9b-7a555b26fe0d", "id": "e1e28a49-a526-42b0-8a64-c3546094962f", "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": "20130129", "inactive_ingredient": [ "Inactive I ngredients Aspartame* (see warning) Benzoic Acid, Citric Acid, Clear Grape Flavor, Glycerin, Hydroxypropylmethylcellulose, Menthol, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water." ], "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 Do not exceed recommended dosage. *Phenylketonurics: Contains Phenylalanine. When using this product Don’t take more than the recommended dosage. Ask a doctor before use if you have a Cough that occurs with too much phlegm (mucus). a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Stop use a nd ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , Do Not 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 Don’t take more than the recommended dosage." ], "spl_product_data_elements": [ "Scot-Tussin Expectorant SF Cough Guaifenesin GUAIFENESIN GUAIFENESIN ASPARTAME BENZOIC ACID CITRIC ACID MONOHYDRATE GLYCERIN HYPROMELLOSES MENTHOL METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL WATER" ], "ask_doctor": [ "Ask a doctor before use if you have a Cough that occurs with too much phlegm (mucus). a Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions : Follow Dosage Chart. Do not take more than the six doses in any 24 hour period. This product is not intended for use in children under 12 years of age. age dose Adults and children over 12 years old 2 teaspoons (2 tsp. 10 ml) every 4 hours Children Under 12 years old DO NOT USE" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , Do Not Use." ], "spl_unclassified_section": [ "", "Other Information each teaspoon contains Phenylalanine 2.5 mg store at 20º – 25º C (68º – 77º F). do not refigerate. dosage cup provided." ], "stop_use": [ "Stop use a nd ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 0372-0006-04 SCOT-TUSSIN EXPECTORANT COUGH 4 FL OZ (118 ml) Principal Display Panel" ], "indications_and_usage": [ "Uses Helps loosen phlegm (mucus) to make coughs more productive thereby relieving chest congestion." ], "set_id": "2cd6ab31-1fae-4737-b6af-50586323b751", "id": "a02a5ca8-8c0d-4be5-92b1-5271d555f252", "active_ingredient": [ "Active Ingredient : (in each 5 mL. tsp. teaspoon ) Guaifenesin 100mg" ], "dosage_and_administration_table": [ "
age dose
Adults and children over 12 years old 2 teaspoons (2 tsp. 10 ml) every 4 hours
Children Under 12 years old DO NOT USE
" ] }, { "effective_time": "20131205", "inactive_ingredient": [ "Inactive ingredients aspartame, D&C red #27 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, sorbitol." ], "purpose": [ "Purposes Antacid Antacid Antigas" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children." ], "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 this product if you have kidney disease, except under the advice and supervision of a physician Ask a doctor or pharmacist before use if you are on a magnesium restricted diet presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last for more than 2 weeks side effects occur Keep this and all drugs out of the reach of children. If you are pregnant or breast feeding , ask a health professional before use." ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "Medique Alamag Plus ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, SILICON DIOXIDE ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE SILICON DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ASPARTAME D&C RED NO. 27 MAGNESIUM STEARATE SORBITOL pink ROUND RH;064 CHERRY" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Chew 1 to 4 tablets 4 times a day, 20 minutes to 1 hour after meals or at bedtime, or as directed by a physician. May also be taken as needed, up to 16 tablets in a 24 hour period. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If you are pregnant or breast feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information phenylketonurics: contains phenylalanine 2.6 mg per tablet contains 83 mg magnesium per tablet store at room temperature 59º-86ºF (15º-30ºC) protect from excessive moisture tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if symptoms last for more than 2 weeks side effects occur" ], "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 this product if you have kidney disease, except under the advice and supervision of a physician" ], "package_label_principal_display_panel": [ "Principal Display Panel – 247R Medique Alamag Plus Label Medique® Alamag Plus Antacid/Anti-Gas Antiacido/Antigas Aluminum Hydroxide, Magnesium Hydroxide & Simethicone Formula Pull to Open Tire Para Abrir Cherry Flavor Sabor a Cereza Great Tasting Chewable Tablets Gran Sabor Tabletas Masticables 100 Tablets (50 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias Principal Display Panel – 247R Medique Alamag Plus Label" ], "indications_and_usage": [ "Uses For the relief of acid indigestion heartburn sour stomach symptoms of gas upset stomach associated with these symptoms" ], "set_id": "30e8971d-e824-41f7-b7f2-fd90e3035da5", "id": "513feac4-abae-4fdf-80b9-831f8688651b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are on a magnesium restricted diet presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each tablet) Aluminum Hydroxide (equivalent to dried gel, USP) 200 mg Magnesium Hydroxide 200 mg Simethicone 25 mg" ] }, { "effective_time": "20140520", "inactive_ingredient": [ "Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "TopCare Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Acesulfame Aspartame Citric acid monohydrate Maltodextrin Sodium Citrate Sucrose Natural Honey and Lemon Flavor Natural Honey and Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "31108eec-b555-4dd3-afe3-4073cb1be075", "id": "9d086914-86f6-45f3-8bfa-4bdb00fdc3bf", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant." ] }, { "effective_time": "20131202", "inactive_ingredient": [ "Inactive ingredients aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc" ], "purpose": [ "Purpose Acid reducer Antacid Antacid" ], "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 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 you 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 l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. 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": [ "Questions or comments? call toll-free 1-800-897-7535 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "Tums Dual Action famotidine, calcium carbonate and magnesium hydroxide FAMOTIDINE FAMOTIDINE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION ASPARTAME D&C RED NO. 7 DEXTRATES FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 GLYCERYL MONOSTEARATE ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 POVIDONES TALC light and dark pink TUMS;3" ], "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 l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ∘ do not swallow tablet whole: chew completely ∘ to relieve symptoms, chew 1 tablet before swallowing ∘ do not use more than 2 chewable 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 • each tablet contains: calcium 320mg; magnesium 65mg • Phenylketonurics: Contains Phenylalanine 2.2mg per tablet • read the directions and warnings before use • read the bottle label. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture" ], "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 you doctor. • with other acid reducers" ], "package_label_principal_display_panel": [ "Principal Display Panel TUMS DUAL ACTION Famotidine 10mg/Calcium Carbonate 800mg Magnesium Hydroxide 165mg Tablets ACID REDUCER+ANTACID JUST ONE TABLET relieves heartburn due to acid indigestion 50 CHEWABLE TABLETS BERRY FLAVOR Tips For Managing Heartburn • Do not lie flat or bend over after eating • Do not wear tight-fitting clothing around the stomach • Do not eat before bedtime • Raise the head of your bed • Avoid heartburn causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables • Eat slowly and avoid big meals • If overweight, lose weight • Quit smoking DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2008 GlaxoSmithKline www.tums.com 62079XA Tums Dual Action 50 tablet carton" ], "indications_and_usage": [ "Use relieves heartburn associated with acid indigestion and sour stomach" ], "set_id": "3305ba7c-a319-4bc8-a80d-ae714c0c3cb8", "id": "dcb09646-5c8a-48c5-989a-305850df2cc3", "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 chewable tablet) Famotidine 10mg Calcium carbonate 800mg Magnesium hydroxide 165mg" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Acesulfame K, aspartame, caramel color, citric acid, D and C Yellow 10, maltodextrin, natural flavors, sodium citrate, starch and sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose and throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey & Lemon Flavor Natural Honey & Lemon Flavor Caramel Color D & C Yellow 10" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor - If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "331f14b8-55fb-4ad8-83a8-95a7ed740c82", "id": "267ca7df-1a15-6d1b-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg .......................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg .................................Nasal decongestant." ] }, { "effective_time": "20120809", "inactive_ingredient": [ "Inactive ingredients aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide. DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING" ], "purpose": [ "Purpose Bulk-forming laxative" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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 the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake" ], "spl_product_data_elements": [ "Health Mart fiber psyllium husk PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary adults and children 12 years and over 1 rounded teaspoon 6 to under 12 years 1/2 teaspoon under 6 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Fiber Supplement Information Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program. Warnings Read entire label, including warnings in Drug Facts Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz of liquid 3 times daily. Children under 12 years : Consult a doctor. NOTICE : Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you havbe difficulty swallowing. See choking warning." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 30 mg and sodium 5 mg Phenylketonurics: contains phenylalanine 25 mg per teaspoon store at (20 o -25 o C) 68 o -77 o F" ], "package_label_principal_display_panel": [ "PDP Health Mart Pharmacy Compare to Metamucil ® active ingredient fiber powder psyllium husk 3.4 g bulk-forming laxative dietary fiber supplement helps maintain and restore regularity sugar free smooth texture orange flavor net wt 10 oz (283 g) 48 teaspoon doses sugar free smooth texture" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "352b19c5-12d2-45c5-b161-0d9fdc0cdc57", "id": "4a145697-965e-4a46-81cc-b99535f3c132", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (per each rounded teaspoon=5.8 g) psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 rounded teaspoon
6 to under 12 years 1/2 teaspoon
under 6 years ask a doctor
" ] }, { "effective_time": "20151208", "inactive_ingredient": [ "Acesulfame K, aspartame, calcium phosphate dibasic, citric acid, D and C Yellow 10, maltodextrin, natural flavor, silicon dioxide, sodium citrate dihydrate." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose and throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough Natural honey lemon flavor Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. ACESULFAME ASPARTAME CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CITRIC ACID MONOHYDRATE MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey & Lemon Flavor Natural Honey & Lemon Flavor D & C Yellow 10" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor - If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - With any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 10 mg, sodium 19 mg - phenylketonurics: contains phenylalanine 11 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "3568f379-3743-4a83-b7b1-887c19d24020", "id": "2665a8b7-5f72-401c-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg .......................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg .................................Nasal decongestant." ] }, { "effective_time": "20120606", "purpose": [ "Purposes Pain Reliever/Fever Reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product: Do not exceed recommended dose." ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pain due to: ■ The common cold ■ Flu ■ Headache ■ Sore throat ■ Toothache Temporarily reduces fever." ], "set_id": "36f1d428-8f00-4fe1-81da-f37f914d90d7", "id": "38049cd9-c84f-40a5-9f6c-b3a07c8170a3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active Ingredient (in each chewable tablet) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Weight Age Tablets
Under 24 lbs Under 2 years Ask a doctor
24-35 lbs 2-3 years 2 tablets
36-47 lbs 4-5 years 3 tablets
48-59 lbs 6-8 years 4 tablets
60-71 lbs 9-10 years 5 tablets
72-95 lbs 11 years 6 tablets
" ], "inactive_ingredient": [ "Inactive Ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ 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 other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product: Do not exceed recommended dose. Stop use and ask a doctor if ■ Pain gets worse or lasts more than 5 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. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.", "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." ], "spl_product_data_elements": [ "Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ASPARTAME SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE MANNITOL POVIDONE STARCH, CORN SODIUM CHLORIDE SODIUM STARCH GLYCOLATE TYPE A POTATO SORBITOL STEARIC ACID SUCRALOSE ROUND BICONVEX TABLET 1G" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ This products does not contain directions or complete warnings for adult use. ■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age. ■ Chew before swallowing ■ If needed, repeat dose every 4 hours while symptoms lasts ■ Do not give more than 5 times in 24 hours ■ Do not give for more than 5 days unless directed by a doctor. Weight Age Tablets Under 24 lbs Under 2 years Ask a doctor 24-35 lbs 2-3 years 2 tablets 36-47 lbs 4-5 years 3 tablets 48-59 lbs 6-8 years 4 tablets 60-71 lbs 9-10 years 5 tablets 72-95 lbs 11 years 6 tablets" ], "package_label_principal_display_panel_table": [ "
See New Warnings Information
" ], "stop_use": [ "Stop use and ask a doctor if ■ Pain gets worse or lasts more than 5 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 Phenylketonurics: Contain Phenylalanine 14 mg per tablet Do not use if imprinted safety seal under cap is broken or missing Store at room temperature in a dry place" ], "do_not_use": [ "Do not use ■ with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "Questions? Adverse Drug Event Call: (800) 616-2471", "Principal Display Panel NDC 54868-5625-0 *Compare to the active ingredient in Children's Chewable Tylenol® Children's Chewable AGES 2-6 Acetaminophen Chewable Tablets 30 Tablets, 80 mg EACH Fever reducer/ Pain reliever ASPIRIN FREE ● IBUPROFEN FREE See New Warnings Information Fruit Flavor image of package label" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms." ] }, { "effective_time": "20121106", "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 GOOD NEIGHBOR PHARMACY ® Compare to active ingredient in Claritin ® Reditabs ®** NDC 46122-0140-52 Non-Drowsy * 24 HOUR Allergy Relief loratadine orally disintegrating tablets, 10 mg antihistamine no water needed melts in your mouth Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose For Adults and Children Six Years and Older 10 orally disintegrating tablets * When taken as directed. See Drug Facts Panel. Distributed By: AmerisourceBergen 5095010/R0412 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": "3cb958e5-759a-4934-ac14-f75e3804778c", "id": "fd7412ea-a337-49d7-b25e-012e193111b5", "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": "20130401", "inactive_ingredient": [ "Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "CVS Pharmacy Nighttime Severe Cough and Cold honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Acesulfame Aspartame Citric acid monohydrate Maltodextrin Sodium Citrate Sucrose Natural Honey and Lemon Flavor Natural Honey and Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - If you are now taking a prescription monoamine oxidase (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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "3e059551-39ce-45d1-8cc4-fdd76135544f", "id": "c73f9aba-85ae-4825-9fd4-572d4f28bc89", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant." ] }, { "effective_time": "20150129", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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" ], "questions": [ "Questions or Comments? Call 1-800-ShopRite" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "4aeb7f40-b315-48e4-97dc-237d06d0f2d4", "id": "3fab182d-ff94-4826-9d35-b2760f776dd2", "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 packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 care professional before use. Keep out of reach of children. 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": [ "ShopRite DayTime Flu Plus Severe Cold And Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: Wakefern Food Corp. 5000 Riverside Drive Keasbey, NJ 08832" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton Compare to: Active Ingredients in Theraflu ® Daytime Severe Cold & Cough See New Warnings Information & Directions ShopRite ® Daytime FLU & SEVERE COLD & COUGH ACETAMINOPHEN Pain Reliever/Fever Reducer DEXTROMETHORPHAN HBr Cough Suppressant PHENYLEPHRINE HCl Nasal Decongestant Nasal & Sinus Congestion, Cough, Body Ache, Sore Throat Pain, Headache, Fever Berry Infused with Menthol & Green Tea Flavor 6 PACKETS Principal Display Panel - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20120307", "inactive_ingredient": [ "Inactive ingredients aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Enter section text here If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll-free 1-866-751-9303" ], "spl_product_data_elements": [ "Good Sense Nicotine Nicotine Polacrilex NICOTINE NICOTINE ASPARTAME MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM L344" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User’s Guide for complete directions and other important information stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "pregnancy_or_breast_feeding": [ "If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat" ], "storage_and_handling": [ "Other information each lozenge contains: sodium 15 mg Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge sugar alcohol content: 1 g mannitol per lozenge store at 20-25°C (68-77°F) keep vial closed and protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68258-7991-07 NDC 68258-7991-07" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving associated with quitting smoking" ], "set_id": "4bb7687d-3ee0-47a3-aa43-146dede4cf55", "id": "4b7832cb-8420-47b0-b947-363aa54e2ca1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 2 mg (nicotine)" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every1 to 2 hours 1 lozenge every2 to 4 hours 1 lozenge every4 to 8 hours
" ] }, { "effective_time": "20150609", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a heath care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "4bc5a105-aed4-4c62-a389-c17678cd5d77", "id": "d95641a2-6c74-4fdf-bdac-77773a41f921", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care professional before use. Keep out of reach of children. 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": [ "Nighttime Flu and Severe Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine acesulfame potassium aspartame ANHYDROUS CITRIC ACID D&C yellow no. 10 FD&C blue No. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton NDC 51672-2113-7 Compare to the active ingredients in Theraflu ® Nighttime Severe Cold & Cough* See New Warnings Information & Directions Nighttime Flu & Severe Cold & Cough Acetaminophen - Pain reliever/fever reducer Diphenhydramine HCl - Antihistamine/cough suppressant Phenylephrine HCl - Nasal decongestant Nasal Congestion Sore Throat Pain Cough Headache Body Ache Fever Runny Nose Sneezing Honey Lemon Infused with Chamomile & White Tea Flavors 6 Packets Principal Display Panel - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20140922", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid, FD&C Red No. 40, maltodextrin, natural flavor" ], "purpose": [ "Purpose Fiber therapy for regularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away." ], "warnings": [ "Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away." ], "questions": [ "Questions? 1-800-983-4237" ], "spl_product_data_elements": [ "Metamucil Therapy for Regularity Psyllium Husk Psyllium Husk Psyllium Husk acesulfame potassium aspartame citric acid monohydrate FD&C Red No. 40 maltodextrin" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning . Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. New Users Start with 1 dose per day; gradually increase to 3 doses per day as necessary." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 35 mg PHENYLKETONURICS: CONTAINS PHENYLALANINE, 19 mg per teaspoon store at room temperature tightly closed to protect from humidity see bottom of canister for expiration date contains a 100% natural, therapeutic fiber" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 432 g Canister Label NDC 37000-655-15 Doctor # 1 Recommended Brand 100% Natural Psyllium Daily fiber supplement/ Therapy for regularity Metamucil ® MultiHealth Fiber ✓ Helps lower cholesterol to promote heart health* ✓ Promotes digestive health † ✓ Low glycemic index* † ✓ Gluten free (less than 20 ppm gluten)* Sugar-free Not a low calorie product. Pink Lemonade smooth Psyllium fiber powder Naturally flavored NET WT 15.2 OZ (432 g) 72 DOSES *See back for information about soluble fiber and heart disease and for information about low glycemic index and gluten. †These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Principal Display Panel - 432 g Canister Label" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "4d29b6d7-cb4a-4952-aca6-ec7950efbbe5", "id": "4a116ec8-d060-4fbb-9cf3-cb23c31ccac0", "active_ingredient": [ "Active ingredient (in each TEASPOON) Psyllium husk approximately 3.3 g" ], "dosage_and_administration_table": [ "
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours.
6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily
Under 6 yrs. Consult a doctor
" ] }, { "effective_time": "20120502", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid" ], "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: 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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water 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 child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within the first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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 mouth or throat burning may occur; give with food or water 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": [ "Ibuprofen Junior Ibuprofen IBUPROFEN IBUPROFEN ASPARTAME CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MANNITOL SILICON DIOXIDE SODIUM LAURYL SULFATE SOYBEAN OIL SUCCINIC ACID ACESULFAME POTASSIUM L461" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within the first day (24 hours) of treatment fever or pain 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 phenylketonurics: contains phenylalanine 6 mg per tablet do not use if printed seal under cap is broken or missing store at 20-25°C (68-77°F) see end panel for lot number and expiration date" ], "do_not_use": [ "Do not use if the child has 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 junior strength Ibuprofen tablets, 100 mg Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours NDC 54868-5623-0 24 chewable tablets Compare to Motrin® Junior Strength active ingredient See New Warnings Information FOR AGES 2 TO 11 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 image of package label" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "4de8b851-adce-443e-a3a1-62a887b8dd96", "id": "a325acae-9aca-40b7-92f9-73e7b35a90cd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24-35 2-3 1
36-47 4-5 1 ½
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3
" ] }, { "effective_time": "20151208", "inactive_ingredient": [ "Nighttime Inactive Ingredient Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.", "Daytime Inactive Ingredient Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Purpose Nighttime Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever.", "Purpose Daytime Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Keep out of reach of children. 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." ], "warnings": [ "Nighttime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Daytime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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": [ "Walgreens Daytime Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr Walgreens Nighttime Wal-Flu Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon flavor Caramel color D and C Yellow 10 Walgreens Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors Menthol FD and C Red No 40 FD and C Blue No 1" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Nighttime Dosage & Administration Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.", "Daytime Dosage & Administration Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "do_not_use": [ "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "information_for_patients": [ "Nighttime Information for Patients Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.", "Daytime Information for Patients Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "set_id": "4e7475e2-af73-4bcb-8f75-f5528b9f9921", "id": "266680c2-4176-6a99-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "overdosage": [ "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.", "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." ], "active_ingredient": [ "Active Ingredients for Nighttime Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.", "Active Ingredients for Daytime Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20130204", "inactive_ingredient": [ "Inactive Ingredients *Aspartame (see warning), Benzoic Acid, Citric Acid, Glycerin, Hydroxypropylmethylcellulose, Menthol, Methyl Paraben, Peppermint Stick Flavor, Propyl Paraben, Propylene Glycol, Purified Water." ], "purpose": [ "Purpose Cough Suppressant Expectorant" ], "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 *Phenylketonurics: Contains Phenylalanine. Do not use more than the recommended dosage. If drowsiness occurs, do not drive or operate machinery. if you are 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 is you have A chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Difficulty in urination due to enlargement of the prostate gland. A Cough accompanied by excessive phlegm (mucus). Glaucoma. Thyroid disease. Stop use a nd ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , Do Not Use. Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Scot-Tussin Senior SF DMEXP Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ASPARTAME BENZOIC ACID CITRIC ACID MONOHYDRATE GLYCERIN HYPROMELLOSES MENTHOL METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL WATER Peppermint Stick" ], "ask_doctor": [ "Ask a doctor before use is you have A chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Difficulty in urination due to enlargement of the prostate gland. A Cough accompanied by excessive phlegm (mucus). Glaucoma. Thyroid disease." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions Follow Dosage Chart. Do not take more than 4 doses in any 24 hour period. This product is not intended for use in children under 12 years of age. age dose Adults and children over 12 years old 2 teaspoons (2 tsp. 10 ml) every 6 hours Children Under 12 years old DO NOT USE" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , Do Not Use." ], "spl_unclassified_section": [ "", "Other Information Each teaspoon contains Phenylalanine 7.5 mg. Store at 20º – 25º C (68º – 77º F). Do not refrigerate. Dosage cup provided." ], "stop_use": [ "Stop use a nd ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use more than the recommended dosage. If drowsiness occurs, do not drive or operate machinery. if you are 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 0372-0050-04 SCOT-TUSSIN SENIOR Maximum Strength COUGH SUPPRESSANT & EXPECTORANT 4 FL OZ (118 ml) NDC 0372-0050-04 SCOT-TUSSIN SENIOR Maximum Strength COUGH SUPPRESSANT & EXPECTORANT 4 FL OZ (118 ml)" ], "indications_and_usage": [ "Uses Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. Quiets and calms a dry cough. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive thereby relieving chest congestion." ], "set_id": "4f0aefe3-e80f-44b8-bc24-1a325f36c2d3", "id": "29bdfa32-2dde-4ea0-a23a-6b68ed05d44f", "active_ingredient": [ "Active Ingredients: (in each 5 mL. tsp. teaspoon ) Dextromethorphan HBr. USP 15mg Guaifenesin USP 200mg" ], "dosage_and_administration_table": [ "
age dose
Adults and children over 12 years old 2 teaspoons (2 tsp. 10 ml) every 6 hours
Children Under 12 years old DO NOT USE
" ] }, { "effective_time": "20120404", "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 1-888-423-0139" ], "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 Topcare ® NDC 36800-528-69 Ages 6 years and older Children's MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED Original Prescription Strength 24 HOUR NON-DROWSY * Allergy Relief LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg ANTIHISTAMINE Indoor & Outdoor Allergies For 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose COMPARE TO CLARITIN ® REDITABS ® active ingredient † 10 ORALLY DISINTEGRATING TABLETS * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY TOPCO ASSOCIATES LLC 5095193/R812 This is the 10 count blister carton label for TopCare Loratadine ODT, USP 10 mg (Children's)." ], "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": "52e8e5c4-a552-4adf-b71b-9259e7822fae", "id": "dc5acc2d-e646-4db3-97f2-77e16b4b34ef", "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": "20131106", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid" ], "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: 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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] takes more or for a longer time than directed Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water 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 child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within the first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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 mouth or throat burning may occur; give with food or water 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": [ "Good Sense ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ASPARTAME CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MANNITOL SILICON DIOXIDE SODIUM LAURYL SULFATE SOYBEAN OIL SUCCINIC ACID ACESULFAME POTASSIUM L461" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within the first day (24 hours) of treatment fever or pain 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 phenylketonurics: contains phenylalanine 6 mg per tablet do not use if printed seal under cap is broken or missing store at 20-25°C (68-77°F) see end panel for lot number and expiration date" ], "do_not_use": [ "Do not use if the child has 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 For Ages 2 to 11 See New Warnings Information Junior Strength Ibuprofen Tablets, 100 mg Lasts Up To 8 Hours Pain Reliever / Fever Reducer (NSAID) Orange Flavor Compare to active ingredient of Motrin® Junior Strength NDC 68258-2994-02 NDC 68258-2994-02" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "56cb55bf-3fd8-4613-bc45-73e53204dc97", "id": "a601000f-dbf5-4d7b-b1d2-72bfb36db5ea", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24-35 2-3 1
36-47 4-5 1 ½
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3
" ] }, { "effective_time": "20150427", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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" ], "questions": [ "Questions or Comments? Call 1-800-632-6900" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "598503d8-d847-42c0-9cfc-67710e1a62d6", "id": "21318d98-c0c0-4d15-9a6f-2dd819f759f3", "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 packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 care professional before use. Keep out of reach of children. 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": [ "Kroger DayTime Flu plus Severe Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton COMPARE TO the active ingredients of THERAFLU ® DAYTIME SEVERE COLD & COUGH *See side panel SEE NEW WARNINGS INFORMATION & DIRECTIONS NDC 30142-112-07 Kroger ® FROM OUR FAMILY TO YOURS DayTime Flu + Severe Cold & Cough Acetaminophen, Pain Reliever/Fever Reducer Dextromethorphan HBr, Cough Suppressant Phenylephrine HCl, Nasal Decongestant Nasal & Sinus Congestion Cough Body Ache Sore Throat Pain Headache Fever • Our Pharmacists • Recommend 6 PACKETS BERRY INFUSED WITH MENTHOL & GREEN TEA FLAVORS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20151204", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "WinCo Foods Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "5c5abb31-27d8-4c87-9467-7b07743521ff", "id": "26195b21-ebb7-6a11-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20151230", "recent_major_changes": [ "Indications and Usage, Gonorrhea ( 1.5 ) Removed 9/2015 Dosage and Administration, Gonorrhea ( 2.1 ) Removed 9/2015" ], "drug_interactions": [ "7 DRUG INTERACTIONS Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. ( 7.1 ) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Coadministration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented. 7.6 Effects on Laboratory Tests High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.", "7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.", "7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.", "7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.", "7.4 Oral Contraceptives Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.", "7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented.", "7.6 Effects on Laboratory Tests High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted." ], "geriatric_use": [ "8.5 Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function." ], "references": [ "15 REFERENCES Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67. Clinical and Laboratory Standards Institute (CLSI ). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition . CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI document M100-S25. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015." ], "microbiology_table": [ "
Table 4. Susceptibility Interpretive Criteria for Amoxicillin
Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm)
Susceptible Intermediate Resistant Susceptible Intermediate Resistant
Streptococcus P neumoniae (non-meningitis isolates)* ≤ 2 4 ≥ 8 - - -
* S. pneumoniae should be tested using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm4.
", "
Table 5. Acceptable Quality Control Ranges for Amoxicillina
Quality Control Microorganism Minimum Inhibitory Concentrations (mcg/mL) Disc Diffusion Zone Diameter (mm)
Streptococcus pneumoniae ATCCb 49619 0.03 to 0.12 ----
Klebsiella pneumoniae ATCC 700603 > 128 ----
a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase4. b ATCC = American Type Culture Collection
" ], "description": [ "11 DESCRIPTION Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S ,5 R ,6 R )-6-[( R )-(-)-2-amino-2-( p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­ 2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S·3H 2 O, and the molecular weight is 419.45. Chemical structure of Amoxicillin Amoxicillin Capsules, USP Each capsule, for oral administration, provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin Inactive Ingredients: CAPSULES-DRUG PRODUCT: Magnesium Stearate, Sodium Lauryl Sulfate. CAPSULE SHELL AND PRINT CONSTITUENTS: Gelatin, Sodium Lauryl Sulfate, Titanium Dioxide, D&C Red No. 33; FD&C Blue No. 1; FD&C Red No. 40; FD&C Yellow No. 6. In addition, each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets, USP Each tablet, for oral administration, provide amoxicillin trihydrate equivalent to 875 mg amoxicillin. Inactive Ingredients: TABLETS: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide. In addition, each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension, USP Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin, when the dry powder is reconstituted according to directions.Inactive Ingredients: SUSPENSION: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide, Flavors, Microcrystalline Cellulose, Sodium Citrate, Sodium Propionate, Sucrose, FD&C Red No. 40, FD&C Yellow No. 6. In addition, each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium. Amoxicillin Tablets, USP (Chewable) Each chewable tablet, for oral administration, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg amoxicillin. Inactive Ingredients: CHEWABLE TABLETS: Aspartame*, Flavor, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, FD&C Red No. 40. THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY PHENYLKETONURICS: CONTAINS PHENYLALANINE. [*see PRECAUTIONS ] ." ], "nonclinical_toxicology": [ "13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area)." ], "labor_and_delivery": [ "8.2 Labor and Delivery Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention." ], "dosage_forms_and_strengths": [ "3 DOSAGE FORMS AND STRENGTHS Amoxicillin Capsules 250 mg: Peach/orange capsule marked WC 730. Each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin as the trihydrate. 500 mg: Peach/orange capsule marked WC 731. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin as the trihydrate. Amoxicillin for Oral Suspension 125 mg/5 mL: Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin. 250 mg/ 5 mL: Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin. Amoxicillin Tablets 875 mg: White, oblong, film-coated tablet engraved S score line 145 on one side. Each tablet contains 875 mg amoxicillin as the trihydrate. Amoxicillin Tablets, (Chewable) 125 mg: Pink, biconvex, oval embossed 231 on one side and logo on reverse. Each tablet contains 125 mg amoxicillin as the trihydrate. 250 mg: Pink, biconvex, oval embossed 232 on one side and logo on reverse. Each tablet contains 250 mg amoxicillin as the trihydrate. Capsules: 250 mg, 500 mg ( 3 ) Tablets: 875 mg ( 3 ) Powder for Oral Suspension: 125 mg/5 mL, 250 mg/5 mL ( 3 ) Tablets (chewable): 125 mg, 250 mg ( 3 )" ], "clinical_pharmacology_table": [ "
Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults
Dose* Amoxicillin AUC0-∞ (mcg·hr/mL) Amoxicillin (±S.D.) Cmax (mcg/mL)† Amoxicillin (±S.D.)
400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62)
400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64)
* Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
", "
Table 4. Susceptibility Interpretive Criteria for Amoxicillin
Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm)
Susceptible Intermediate Resistant Susceptible Intermediate Resistant
Streptococcus P neumoniae (non-meningitis isolates)* ≤ 2 4 ≥ 8 - - -
* S. pneumoniae should be tested using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm4.
", "
Table 5. Acceptable Quality Control Ranges for Amoxicillina
Quality Control Microorganism Minimum Inhibitory Concentrations (mcg/mL) Disc Diffusion Zone Diameter (mm)
Streptococcus pneumoniae ATCCb 49619 0.03 to 0.12 ----
Klebsiella pneumoniae ATCC 700603 > 128 ----
a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase4. b ATCC = American Type Culture Collection
" ], "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 as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN." ], "mechanism_of_action": [ "12.1 Mechanism of Action Amoxicillin is an antibacterial drug. [see Microbiology (12.4) ]." ], "pharmacokinetics_table": [ "
Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults
Dose* Amoxicillin AUC0-∞ (mcg·hr/mL) Amoxicillin (±S.D.) Cmax (mcg/mL)† Amoxicillin (±S.D.)
400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62)
400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64)
* Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
" ], "pharmacokinetics": [ "12.3 Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400-mg and 875-mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250-mg and 500-mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively. Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin tablets with 875 mg of AUGMENTIN ® (amoxicillin/clavulanate potassium) showed that the 875-mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg·hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively. Oral administration of single doses of 400-mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose* Amoxicillin AUC 0-∞ (mcg·hr/mL) Amoxicillin (±S.D.) C max (mcg/mL) † Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) * Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose. Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1-gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] ." ], "clinical_studies_table": [ "
Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen
Study Triple Therapy Triple Therapy
Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients)
Study 1 92 [80.0 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55)
Study 2 86 [75.7 - 93.6] (n = 66) 83 [72.0 - 90.8] (n = 70)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
", "
Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen
Study Dual Therapy Dual Therapy
Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients)
Study 1 77 [62.5 - 87.2] (n = 51) 70 [56.8 - 81.2] (n = 60)
Study 2 66 [51.9 - 77.5] (n = 58) 61 [48.5 - 72.9] (n = 67)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
", "
Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen
Study Triple Therapy Triple Therapy
Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients)
Study 1 92 [80.0 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55)
Study 2 86 [75.7 - 93.6] (n = 66) 83 [72.0 - 90.8] (n = 70)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
", "
Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen
Study Dual Therapy Dual Therapy
Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients)
Study 1 77 [62.5 - 87.2] (n = 51) 70 [56.8 - 81.2] (n = 60)
Study 2 66 [51.9 - 77.5] (n = 58) 61 [48.5 - 72.9] (n = 67)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
" ], "indications_and_usage": [ "1 INDICATIONS AND USAGE Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . 1.2 Infections of the Genitourinary Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . 1.3 Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . 1.4 Infections of the Lower Respiratory Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . 1.5 Helicobacter pylori Infection Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY ) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.", "1.1 Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae .", "1.2 Infections of the Genitourinary Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .", "1.3 Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli .", "1.4 Infections of the Lower Respiratory Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae .", "1.5 Helicobacter pylori Infection Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY ) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.", "1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy." ], "set_id": "5d22f9b8-3022-42e8-a427-fc43c589c92c", "id": "ef265f67-ee55-47b7-9f2b-a4d4dfd51096", "dosage_and_administration_table": [ "
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age
Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb
Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
", "
Table 2. Amount of Water for Mixing Oral Suspension
Strength Bottle Size Amount of Water Required for Reconstitution
Oral Suspension 125 mg/5 mL 80 mL 69 mL
100 mL 86 mL
150 mL 128 mL
Oral Suspension 250 mg/5 mL 80 mL 56 mL
100 mL 70 mL
150 mL 104 mL
", "
Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age
Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb
Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
", "
Table 2. Amount of Water for Mixing Oral Suspension
Strength Bottle Size Amount of Water Required for Reconstitution
Oral Suspension 125 mg/5 mL 80 mL 69 mL
100 mL 86 mL
150 mL 128 mL
Oral Suspension 250 mg/5 mL 80 mL 56 mL
100 mL 70 mL
150 mL 104 mL
" ], "pediatric_use": [ "8.4 Pediatric Use Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months) [see Dosage and Administration (2.2) ] ." ], "inactive_ingredient": [ "Amoxicillin Capsules, USP Each capsule, for oral administration, provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin Inactive Ingredients: CAPSULES-DRUG PRODUCT: Magnesium Stearate, Sodium Lauryl Sulfate. CAPSULE SHELL AND PRINT CONSTITUENTS: Gelatin, Sodium Lauryl Sulfate, Titanium Dioxide, D&C Red No. 33; FD&C Blue No. 1; FD&C Red No. 40; FD&C Yellow No. 6. In addition, each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium. Amoxicillin Tablets, USP Each tablet, for oral administration, provide amoxicillin trihydrate equivalent to 875 mg amoxicillin. Inactive Ingredients: TABLETS: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide. In addition, each tablet contains up to 0.032 mEq (0.74 mg) of Sodium. Amoxicillin for Oral Suspension, USP Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin, when the dry powder is reconstituted according to directions.Inactive Ingredients: SUSPENSION: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide, Flavors, Microcrystalline Cellulose, Sodium Citrate, Sodium Propionate, Sucrose, FD&C Red No. 40, FD&C Yellow No. 6. In addition, each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium. Amoxicillin Tablets, USP (Chewable) Each chewable tablet, for oral administration, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg amoxicillin. Inactive Ingredients: CHEWABLE TABLETS: Aspartame*, Flavor, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, FD&C Red No. 40. THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY PHENYLKETONURICS: CONTAINS PHENYLALANINE. [*see PRECAUTIONS ] ." ], "contraindications": [ "4 CONTRAINDICATIONS Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4 )" ], "pregnancy": [ "8.1 Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "8.3 Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman." ], "microbiology": [ "12.4 Microbiology Mechanism of Action Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Mechanism of Resistance Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive. Amoxicillin has been shown to be active against most isolates of the bacteria listed below, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp. (alpha and beta-hemolytic) Gram-Negative Bacteria Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Susceptibility Test Methods : When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial. Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method -(broth or agar) 2,4 . The MIC values should be interpreted according to the criteria in Table 4. Diffusion Techniques: Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds 3,4 . The zone size should be determined using a standardized test method 3 . Susceptibility to amoxicillin of Enterococcus spp., Enterobacteriaceae, and H. influenzae , may be inferred by testing ampicillin 4 . Susceptibility to amoxicillin of Staphylococcus spp., and beta-hemolytic Streptococcus spp., may be inferred by testing penicillin 4 . The majority of isolates of Enterococcus spp. that are resistant to ampicillin or amoxicillin produce a TEM-type beta-lactamase. A beta-lactamase test can provide a rapid means of determining resistance to ampicillin and amoxicillin 4 . Susceptibility to amoxicillin of Streptococcus pneumoniae (non-meningitis isolates) may be inferred by testing penicillin or oxacillin 4 . The interpretive criteria for S. pneumoniae to amoxicillin are provided in Table 4 4 . Table 4. Susceptibility Interpretive Criteria for Amoxicillin Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm) Susceptible Intermediate Resistant Susceptible Intermediate Resistant Streptococcus P neumoniae (non-meningitis isolates)* ≤ 2 4 ≥ 8 - - - * S. pneumoniae should be tested using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm 4 . A report of “Susceptible” indicates the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches a concentration at the infection site necessary to inhibit growth of the pathogen. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site; other therapy should be selected. Susceptibility Testing for Helicobacter pylori Amoxicillin in vitro susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori . Specimens for H. pylori and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used. Quality Control: Standardized susceptibility test procedures 2,3,4 require use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test control. Standard amoxicillin powder should provide the following range of MIC values provided in Table 5 4 . For the diffusion technique the criteria provided in Table 5 should be achieved. Table 5. Acceptable Quality Control Ranges for Amoxicillin a Quality Control Microorganism Minimum Inhibitory Concentrations (mcg/mL) Disc Diffusion Zone Diameter (mm) Streptococcus pneumoniae ATCC b 49619 0.03 to 0.12 ---- Klebsiella pneumoniae ATCC 700603 > 128 ---- a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase 4 . b ATCC = American Type Culture Collection" ], "spl_product_data_elements": [ "Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS MAGNESIUM STEARATE SODIUM LAURYL SULFATE GELATIN TITANIUM DIOXIDE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 PEACH/ORANGE WC;730 Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS MAGNESIUM STEARATE SODIUM LAURYL SULFATE GELATIN TITANIUM DIOXIDE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 PEACH/ORANGE WC;731 Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SODIUM PROPIONATE SUCROSE FD&C RED NO. 40 FD&C YELLOW NO. 6 Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SODIUM PROPIONATE SUCROSE FD&C RED NO. 40 FD&C YELLOW NO. 6 Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS SILICON DIOXIDE LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE S;145 Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS ASPARTAME MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SORBITOL FD&C RED NO. 40 231;logo Amoxicillin Amoxicillin AMOXICILLIN AMOXICILLIN ANHYDROUS ASPARTAME MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SORBITOL FD&C RED NO. 40 232;logo" ], "warnings_and_cautions": [ "5 WARNINGS AND PRECAUTIONS Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. ( 5.1 ) Clostridium difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.2 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted. 5.2 Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated. 5.3 Development of Drug-Resistant Bacteria Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria 5.4 Use in Patients With Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis. 5.5 Phenylketonurics Amoxicillin chewable tablets contain aspartame which contains phenylalanine. Each 125-mg chewable tablet of amoxicillin contains 0.85 mg phenylalanine; each 250-mg chewable tablet contains 1.7 mg phenylalanine. The other formulations of amoxicillin do not contain phenylalanine.", "5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy instituted.", "5.2 Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.", "5.3 Development of Drug-Resistant Bacteria Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria", "5.4 Use in Patients With Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis.", "5.5 Phenylketonurics Amoxicillin chewable tablets contain aspartame which contains phenylalanine. Each 125-mg chewable tablet of amoxicillin contains 0.85 mg phenylalanine; each 250-mg chewable tablet contains 1.7 mg phenylalanine. The other formulations of amoxicillin do not contain phenylalanine." ], "openfda": {}, "version": "6", "dosage_and_administration": [ "2 DOSAGE AND ADMINISTRATION In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1 , 2.2 , 2.3 ) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2 ) Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3 ) Reduce the dose in patients with severe renal impairment (GFR <30 mL/min). ( 2.4 ) 2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months) Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. 2.3 Dosing for H. pylori Infection Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information. 2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis. 2.5 Directions for Mixing Oral Suspension Tap bottle until all powder flows freely. Add approximately ½ of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 69 mL 100 mL 86 mL 150 mL 128 mL Oral Suspension 250 mg/5 mL 80 mL 56 mL 100 mL 70 mL 150 mL 104 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.", "2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.", "2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months) Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.", "2.3 Dosing for H. pylori Infection Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.", "2.4 Dosing in Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.", "2.5 Directions for Mixing Oral Suspension Tap bottle until all powder flows freely. Add approximately ½ of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Table 2. Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Required for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 69 mL 100 mL 86 mL 150 mL 128 mL Oral Suspension 250 mg/5 mL 80 mL 56 mL 100 mL 70 mL 150 mL 104 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required." ], "adverse_reactions": [ "6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] CDAD [see Warnings and Precautions (5.2) ] The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact DAVA Pharmaceuticals at 1-800-444-4011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). Dual therapy: The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts. 6.2 Postmarketing or Other Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. 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 their seriousness, frequency of reporting, or potential causal connection to amoxicillin. Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.2) ] . Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions (5.1) ] . Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported . Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported [see Overdosage (10) ] . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported . These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported . Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.", "6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). Dual therapy: The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.", "6.2 Postmarketing or Other Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. 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 their seriousness, frequency of reporting, or potential causal connection to amoxicillin. Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.2) ] . Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions (5.1) ] . Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported . Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported [see Overdosage (10) ] . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported . These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported . Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases." ], "use_in_specific_populations": [ "8 USE IN SPECIFIC POPULATIONS Pediatric: Modify dose in patients 12 weeks or younger (≤ 3 months). ( 8.4 ) 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. 8.2 Labor and Delivery Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. 8.3 Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. 8.4 Pediatric Use Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months) [see Dosage and Administration (2.2) ] . 8.5 Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosing in Renal Impairment (2.4) for specific recommendations in patients with renal impairment.", "8.6 Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosing in Renal Impairment (2.4) for specific recommendations in patients with renal impairment." ], "how_supplied": [ "16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin Capsules, USP are supplied as follows: Amoxicillin Capsules, USP 250 mg . Peach/orange capsule marked WC 730. Each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin as the trihydrate. NDC 67253-140-10 250 mg - Bottles of 100 NDC 67253-140-50 250 mg - Bottles of 500 Amoxicillin Capsules, USP 500 mg . Peach/orange capsule marked WC 731. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin as the trihydrate. NDC 67253-141-10 500 mg - Bottles of 100 NDC 67253-141-50 500 mg - Bottles of 500 NDC 67253-141-11 500 mg - Bottles of 1000 Amoxicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a pink, bubble gum flavored suspension and is supplied as follows: Amoxicillin for Oral Suspension, USP 125 mg/5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin. NDC 67253-142-08 125 mg/5 ml - 80 mL individual bottles NDC 67253-142-10 125 mg/5 ml - 100 mL individual bottles NDC 67253-142·15 125 mg/5 ml - 150 mL individual bottles Amoxicillin for Oral Suspension, USP 250 mg/ 5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin. NDC 67253-143-08 250 mg/5 mL - 80 ml individual bottles NDC 67253-143-10 250 mg/5 mL -100 ml individual bottles NDC 67253-143-15 250 mg/5 mL - 150 ml individual bottles Amoxicillin Tablets, USP are supplied as follows: Amoxicillin Tablets, USP 875 mg. White, oblong, film-coated tablet engraved S score line 145 on one side. Each tablet contains 875 mg amoxicillin as the trihydrate. NDC 67253-145-02 20 Tablets NDC 67253-145-10 100 Tablets NDC 67253-145-50 500 Tablets Amoxicillin Tablets, USP (Chewable) are supplied as follows: Amoxicillin Tablets, USP (Chewable) 125 mg. Pink, biconvex, oval embossed 231 on one side and logo on reverse. Each tablet contains 125 mg amoxicillin as the trihydrate. NDC 67253-151-06 60 Tablets Amoxicillin Tablets, USP (Chewable) 250 mg. Pink, biconvex, oval embossed 232 on one side and logo on reverse. Each tablet contains 250 mg amoxicillin as the trihydrate. NDC 67253-152-10 100 Tablets NDC 67253-152-50 500 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN." ], "information_for_patients": [ "17 PATIENT COUNSELING INFORMATION Information for Patients Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future. Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals. All brands listed are registered trademarks of their respective owners and not trademarks of DAVA Pharmaceuticals. Manufactured For: DAVA Pharmaceuticals, Inc. Fort Lee, NJ 07024, USA Manufactured By: Suir Pharma Ireland Ltd. Clonmel, Ireland. Rev. 12/15" ], "clinical_studies": [ "14 CLINICAL STUDIES 14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6). Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 [80.0 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55) Study 2 86 [75.7 - 93.6] (n = 66) 83 [72.0 - 90.8] (n = 70) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 - 87.2] (n = 51) 70 [56.8 - 81.2] (n = 60) Study 2 66 [51.9 - 77.5] (n = 58) 61 [48.5 - 72.9] (n = 67) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.", "14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6). Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen Study Triple Therapy Triple Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 92 [80.0 - 97.7] (n = 48) 86 [73.3 - 93.5] (n = 55) Study 2 86 [75.7 - 93.6] (n = 66) 83 [72.0 - 90.8] (n = 70) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy. Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen Study Dual Therapy Dual Therapy Evaluable Analysis a [95% Confidence Interval] (number of patients) Intent-to-Treat Analysis b [95% Confidence Interval] (number of patients) Study 1 77 [62.5 - 87.2] (n = 51) 70 [56.8 - 81.2] (n = 60) Study 2 66 [51.9 - 77.5] (n = 58) 61 [48.5 - 72.9] (n = 67) a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest ® , histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - AMOXICILLIN CAPSULES, USP 250 mg Image of the Amoxicillin Capsules, USP 250 mg 100 capsules label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN CAPSULES, USP 500 mg Image of the Amoxicillin Capsules, USP 500 mg 100 capsules label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN for ORAL SUSPENSION, USP 125 mg/5 mL Image of the Amoxicillin for Oral Suspension, USP 125 mg/5 mL 150 mL label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN for ORAL SUSPENSION, USP 250 mg/5 mL Image of the Amoxicillin for Oral Suspension, USP 250 mg/5 mL 150 mL label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN TABLETS, USP 875 mg Image of the Amoxicillin Tablets, USP 875 mg 100 tablets label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN TABLETS, USP (CHEWABLE) 125 mg Image of the Amoxicillin Tablets, USP (Chewable) 125 mg 60 chewable tablets label", "PRINCIPAL DISPLAY PANEL - AMOXICILLIN Tablets, USP (CHEWABLE) 250 mg Image of the Amoxicillin Tablets, USP (Chewable) 250 mg 100 chewable tablets label" ], "clinical_pharmacology": [ "12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Amoxicillin is an antibacterial drug. [see Microbiology (12.4) ]. 12.3 Pharmacokinetics Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension of amoxicillin has been partially investigated; 400-mg and 875-mg formulations have been studied only when administered at the start of a light meal. Orally administered doses of 250-mg and 500-mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively. Mean amoxicillin pharmacokinetic parameters from an open, two-part , single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin tablets with 875 mg of AUGMENTIN ® (amoxicillin/clavulanate potassium) showed that the 875-mg tablet of amoxicillin produces an AUC 0-∞ of 35.4 ± 8.1 mcg·hr/mL and a C max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast. Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively. Oral administration of single doses of 400-mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data: Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults Dose* Amoxicillin AUC 0-∞ (mcg·hr/mL) Amoxicillin (±S.D.) C max (mcg/mL) † Amoxicillin (±S.D.) 400 mg (5 mL of suspension) 17.1 (3.1) 5.92 (1.62) 400 mg (1 chewable tablet) 17.9 (2.4) 5.18 (1.64) * Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose. Distribution: Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. In blood serum, amoxicillin is approximately 20% protein-bound. Following a 1-gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Metabolism and Excretion: The half-life of amoxicillin is 61.3 minutes. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours. Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Since most of the amoxicillin is excreted unchanged in the urine, its excretion can be delayed by concurrent administration of probenecid [see Drug Interactions (7.1) ] . 12.4 Microbiology Mechanism of Action Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria. Mechanism of Resistance Resistance to amoxicillin is mediated primarily through enzymes called beta-lactamases that cleave the beta-lactam ring of amoxicillin, rendering it inactive. Amoxicillin has been shown to be active against most isolates of the bacteria listed below, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-Positive Bacteria Enterococcus faecalis Staphylococcus spp. Streptococcus pneumoniae Streptococcus spp. (alpha and beta-hemolytic) Gram-Negative Bacteria Escherichia coli Haemophilus influenzae Helicobacter pylori Proteus mirabilis Susceptibility Test Methods : When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial. Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method -(broth or agar) 2,4 . The MIC values should be interpreted according to the criteria in Table 4. Diffusion Techniques: Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds 3,4 . The zone size should be determined using a standardized test method 3 . Susceptibility to amoxicillin of Enterococcus spp., Enterobacteriaceae, and H. influenzae , may be inferred by testing ampicillin 4 . Susceptibility to amoxicillin of Staphylococcus spp., and beta-hemolytic Streptococcus spp., may be inferred by testing penicillin 4 . The majority of isolates of Enterococcus spp. that are resistant to ampicillin or amoxicillin produce a TEM-type beta-lactamase. A beta-lactamase test can provide a rapid means of determining resistance to ampicillin and amoxicillin 4 . Susceptibility to amoxicillin of Streptococcus pneumoniae (non-meningitis isolates) may be inferred by testing penicillin or oxacillin 4 . The interpretive criteria for S. pneumoniae to amoxicillin are provided in Table 4 4 . Table 4. Susceptibility Interpretive Criteria for Amoxicillin Minimum Inhibitory Concentration (mcg/mL) Disk Diffusion (zone diameter in mm) Susceptible Intermediate Resistant Susceptible Intermediate Resistant Streptococcus P neumoniae (non-meningitis isolates)* ≤ 2 4 ≥ 8 - - - * S. pneumoniae should be tested using a 1-mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm 4 . A report of “Susceptible” indicates the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches a concentration at the infection site necessary to inhibit growth of the pathogen. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site; other therapy should be selected. Susceptibility Testing for Helicobacter pylori Amoxicillin in vitro susceptibility testing methods for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori . Specimens for H. pylori and clarithromycin susceptibility test results should be obtained on isolates from patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used. Quality Control: Standardized susceptibility test procedures 2,3,4 require use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test control. Standard amoxicillin powder should provide the following range of MIC values provided in Table 5 4 . For the diffusion technique the criteria provided in Table 5 should be achieved. Table 5. Acceptable Quality Control Ranges for Amoxicillin a Quality Control Microorganism Minimum Inhibitory Concentrations (mcg/mL) Disc Diffusion Zone Diameter (mm) Streptococcus pneumoniae ATCC b 49619 0.03 to 0.12 ---- Klebsiella pneumoniae ATCC 700603 > 128 ---- a QC limits for testing E. coli 35218 when tested on Haemophilus Test Medium (HTM) are ≥ 256 mcg/mL for amoxicillin; testing amoxicillin may help to determine if the isolate has maintained its ability to produce beta-lactamase 4 . b ATCC = American Type Culture Collection" ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area)." ], "overdosage": [ "10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1 . Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis." ] }, { "effective_time": "20130108", "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 OD 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 fred's Non-Drowsy * Allergy Relief Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine No Water Needed, Melts In Your Mouth! INDOOR & OUTDOOR ALLERGIES 24 hour relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Compare To Active Ingredient of Claritin ® RediTabs ®† 30 Orally Disintegrating Tablets * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY: fred's, Inc. 5091232/R1111 This is the 30 count blister carton label for Fred's 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": "5f246f7a-a221-49d1-94cb-526e0685f48c", "id": "cf0be8c3-50d2-4b7f-8120-33754890e2b2", "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": "20140130", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid, FD&C blue 1, FD &C red 40, flavor, maltodextrin, silicon dioxide. DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING" ], "purpose": [ "Purpose Bulk-forming laxative" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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 the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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": [ "Sugar Free Smooth Texture, Berry Flavor psyllium husk PSYLLIUM HUSK PSYLLIUM HUSK ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary adults and children 12 years and over 1 rounded teasponn 6 to under 12 years 1/2 teaspoon under 6 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Fiber Supplement Information Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program. Warnings Read entire label, including warnings in Drug Facts Directions Adults 12 years and older : 1 rounded TEASPOON (tsp) in 8 oz of liquid 3 times daily. Children under 12 years: Consult a doctor. NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you havbe difficulty swallowing. See choking warning." ], "storage_and_handling": [ "Other information each teaspoon contains : potassium 30 mg and sodium 5 mg Phenylketonurics: contains phenylalanine 25 mg per teaspoon store at (20 o -25 o C) 68 o -77 o F" ], "package_label_principal_display_panel": [ "PDP Compare to the active ingredient in Metamucil Sugar Free Natural Fiber Berry Flavor Psyllium Husk Bulk-forming laxative Fiber Laxative Dietary Supplement Smooth Texture Relieves Constipation Restores Regularity 114 Teaspoon Doses Net Wt. 23.3 oz 1.4lbs(660 g) NK1" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "62cbf4ea-5ae5-4f4d-b054-6fe4635a93fe", "id": "44954519-b178-45df-aeb3-44e0a331cef5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "active_ingredient": [ "Active ingredient (per each rounded teaspoon=5.8 g) psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 rounded teasponn
6 to under 12 years 1/2 teaspoon
under 6 years ask a doctor
" ] }, { "effective_time": "20150421", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a heath care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "63ff5e77-324c-469a-aed3-8d444c7ea704", "id": "9139f9de-61d0-44fa-9324-2e466ec8e1a7", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care professional before use. Keep out of reach of children. 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": [ "Rite Aid Nighttime Severe Cold and Cough Relief Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Diphenhydramine hydrochloride Diphenhydramine Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid D&C yellow no. 10 FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "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 nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton RITE AID ® PHARMACY SEE NEW WARNINGS INFORMATION & DIRECTIONS *Compare to the active ingredients in Theraflu ® Severe Cold & Cough nighttime severe cold & cough relief acetaminophen 650 mg diphenhydramine HCl 25 mg phenylephrine HCl 10 mg pain reliever/fever reducer antihistamine/ cough suppressant & nasal decongestant relieves: nasal congestion cough runny nose sneezing body ache sore throat pain headache fever honey lemon infused with chamomile & white tea flavors 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20150427", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-800-632-6900" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a heath care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "656cfa67-301d-4d08-851a-b7d449f1a5ff", "id": "a63dc57c-8300-4005-a71b-fa059b7d5acb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care professional before use. Keep out of reach of children. 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": [ "Kroger NiteTime Flu plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Diphenhydramine hydrochloride DIPHENHYDRAMINE Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid D&C yellow no. 10 FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton COMPARE TO the active ingredients of THERAFLU ® NIGHTTIME SEVERE COLD & COUGH *See side panel SEE NEW WARNINGS INFORMATION & DIRECTIONS NDC 30142-113-07 Kroger ® FROM OUR FAMILY TO YOURS NiteTime Flu + Severe Cold & Cough Acetaminophen, Pain Reliever/Fever Reducer Diphenhydramine HCl, Antihistamine/Cough Suppressant Phenylephrine HCl, Nasal Decongestant Nasal Congestion Sore Throat Pain Runny Nose Body Ache Fever Headache Cough Sneezing • Our Pharmacists • Recommend 6 PACKETS HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS Principal Display Panel - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 mg 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." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not 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." ], "storage_and_handling": [ "Other information each tablet contains: sodium 416 mg Phenylketonurics: Contains Phenylalanine 9 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold or flu with cough: minor aches and pains nasal and sinus congestion headache sore throat cough temporarily reduces fever" ], "set_id": "66f35119-63f8-4655-af6a-201fe4c8394c", "id": "a076da72-adbd-4b9c-b3c3-a6bdd782466d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis When using this product do not exceed recommended dosage Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not 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. 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": [ "Alka-Seltzer Plus Day Non Drowsy Cold Medicine Citrus Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate Aspirin Aspirin Dextromethorphan hydrobromide Dextromethorphan Phenylephrine bitartrate Phenylephrine ASP;ND" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems heart disease diabetes ulcers high blood pressure glaucoma asthma thyroid disease cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® DAY NON-DROWSY COLD 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54212 1 MADE IN MEXICO PRODUCT CODE 82411357 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20120223", "purpose": [ "Purpose Bulk-forming laxative" ], "precautions": [ "Choking : Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "description": [ "*This product is not manufactured or distributed by Procter and Gamble, owner or the registered trademark METAMUCIL. Manufactured in the USA for Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811" ], "storage_and_handling": [ "store below 30 Degree C (86\"F). tightly closed to protect from humidity" ], "indications_and_usage": [ "Uses For relief of occasional constipation and restoring regularity. Natural bulk producing fiber encourages normal elimination without chemical stimulants." ], "set_id": "69c76675-5120-4d59-b045-004da5f9af4a", "id": "36351bb0-be68-4bfc-a7b6-6e3ad434efb3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may effect how other drugs work." ], "active_ingredient": [ "Active Ingredient (in each dose) Psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 12 years and older 1 rounded teaspoon (5.8 g) in 8 oz of liquid. up to 3 times daily.
children 6 to under 12 years 1/2 adult dose in 8 oz. liquid. up to 3 times daily
children under 6 years consult a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide." ], "warnings": [ "Warnings Allergy alert : may cause allergic reaction in people sensitive to inhaled or ingested psyllium." ], "spl_product_data_elements": [ "Natural Vegetable Fiber Orange Flavor Smooth Texture Sugar Free PSYLLIUM HUSK PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE ORANGE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea, vomiting or rectal bleeding a sudden change in bowel habits that persists over a period of 2 weeks constipation associated with gastrointestinal disorders" ], "other_safety_information": [ "In case of overdose, get medical help or contact a Poison Control Center right away." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions This product generally produces effect in 12-72 hours. Put one dose into an empty glass. Fill glass with at least 8 oz of water or your favorite beverage. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other liquid. taking this product without enough liquid may cause choking, see choking warning . can be taken before or after meals Age Dose adults and children 12 years and older 1 rounded teaspoon (5.8 g) in 8 oz of liquid. up to 3 times daily. children 6 to under 12 years 1/2 adult dose in 8 oz. liquid. up to 3 times daily children under 6 years consult a doctor" ], "stop_use": [ "Stop use and ask a doct or if constipation persists beyond 7 days. This could be a sign of a serious condition." ], "spl_unclassified_section": [ "Other information each 5.8g dose contains: potassium 32 mg, sodium 7 mg, calcium 8 mg. PHENYLKETONURICS: contains phenylanine, 21 mg per dose" ], "package_label_principal_display_panel": [ "NDC 0603-0994-63 SUGAR FREE Not a low calorie product *Compare to the Active Ingredient in METAMUCIL ORANGE FLAVOR Natural Vegatable Fiber 100% NATURAL PSYLLIUM FIBER Daily Source of Soluble Fiber Dietary Fiber Supplement/Bulk Forming Laxative Fiber Therapy for Regularity SMOOTH TEXTURE 48 Teaspoon Doses NET WT 10 OZ (283 g) Fill Controlled by weight not volume DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING NaturalVegetableFiber" ] }, { "effective_time": "20130228", "inactive_ingredient": [ "inactive ingredient ASPARTAME", "BRONOPOL", "EDETIC ACID", "MENTHOL", "SUCROSE", "SODIUM BENZOATE", "SORBITOL", "XANTHAN GUM" ], "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": [ "warning Ask a doctor before use if you have •cough that occurs with too much phlegm (mucus) •cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition." ], "spl_product_data_elements": [ "GUAAP GUAIFENESIN GUAIFENESIN GUAIFENESIN MENTHOL SUCROSE SORBITOL SODIUM BENZOATE BRONOPOL EDETIC ACID ASPARTAME XANTHAN GUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "direction •do not take more than 6 doses in any 24-hour period •this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over: 2-4 teaspoons every 4 hours children under 12 years: do not use" ], "package_label_principal_display_panel": [ "product" ], "indications_and_usage": [ "uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive." ], "set_id": "6f6f3aae-a676-4b91-bad3-2a1c798ffe0a", "id": "b4133ea4-5e75-46d7-80b4-e7350c8ce234", "active_ingredient": [ "GUAIFENESIN" ] }, { "effective_time": "20150417", "inactive_ingredient": [ "Inactive ingredients aspartame, butylated methacrylate copolymer, carbomer, carboxymethylcellulose sodium, grape flavor, magnesium stearate, microcrystalline cellulose, povidone, raspberry flavor, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate" ], "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 the child has persistent or chronic cough such as occurs with asthma or chronic bronchitis 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 illness. 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? 1-866-MUCINEX (1-866-682-4639) or www.mucinex.com" ], "spl_product_data_elements": [ "Mucinex for Kids Guaifenesin Guaifenesin Guaifenesin aspartame carboxymethylcellulose sodium magnesium stearate cellulose, microcrystalline povidones sodium bicarbonate sorbitol stearic acid talc triethyl citrate" ], "ask_doctor": [ "Ask a doctor before use if the child has persistent or chronic cough such as occurs with asthma or chronic bronchitis cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions empty entire contents of packet onto tongue and swallow for best taste, do not chew granules do not take more than 6 doses in any 24-hour period Age Dose children 6 years to under 12 years 2 to 4 packets every 4 hours children 4 years to under 6 years 1 to 2 packets every 4 hours children under 4 years do not use" ], "spl_unclassified_section": [ "Drug Facts", "Made in Germany", "Distributed by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224 © RBI 2009" ], "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." ], "storage_and_handling": [ "Other information each packet contains: magnesium 6 mg and sodium 2 mg phenylketonurics : contains phenylalanine 0.6 mg per packet store between 15-25°C (59-77°F) tamper evident: do not use if carton is open or if packets are torn or open" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 12 packet Carton NDC 63824-253-12 Mucinex® Guaifenesin 50 mg EXPECTORANT mini-melts ™ For Kids! Grape Flavor Relieves Chest Congestion Thins And Loosens Mucus 12 GRANULE PACKETS Principal Display Panel - 12 packet Carton" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "70cb01b9-51d5-4f5d-88fc-de52c901f17e", "id": "3f3ae28a-2b39-4616-8fa5-706cdc920967", "active_ingredient": [ "Active ingredient (in each packet) Guaifenesin, USP 50 mg" ], "dosage_and_administration_table": [ "
Age Dose
children 6 years to under 12 years 2 to 4 packets every 4 hours
children 4 years to under 6 years 1 to 2 packets every 4 hours
children under 4 years do not use
" ] }, { "effective_time": "20140417", "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 mouth or throat burning may occur; give with food or water 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? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information phenylketonurics: contains phenylalanine 2.8 mg per tablet store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "7285807f-8196-4f1e-8f10-6b69a8ab250a", "id": "dabe18f7-05fe-483d-8038-2fda05c83715", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24-35 2-3 1
36-47 4-5 1 ½
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate" ], "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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water 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 child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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": [ "Motrin Junior Strength Ibuprofen Ibuprofen Ibuprofen acesulfame potassium anhydrous citric acid aspartame FD&C yellow NO. 6 aluminum oxide fumaric acid hypromelloses magnesium stearate mannitol cellulose, microcrystalline povidones sodium lauryl sulfate sodium starch glycolate type a potato MO;100" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has 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 See New Warnings Information NDC 50580-207-24 Motrin ® Junior Strength For Ages 2 to 11 Lasts up to 8 hours contains Ibuprofen Tablets (NSAID), 100 mg Pain Reliever / Fever Reducer 24 Orange-Flavored Chewable Tablets Principal Display Panel" ] }, { "effective_time": "20120828", "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 1-888-423-0139" ], "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": "2", "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 Topcare ® NDC 36800-527-69 MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED Original Prescription Strength 24 HOUR NON-DROWSY * Allergy Relief LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg ANTIHISTAMINE Indoor & Outdoor Allergies For Adults and Children six years and older! For 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itching Throat or Nose COMPARE TO CLARITIN ® REDITABS ® active ingredient † 10 ORALLY DISINTEGRATING TABLETS * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY TOPCO ASSOCIATES LLC 5095192/R812 This is the 10 count blister carton label for TopCare Loratadine ODT, USP 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": "777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f9", "id": "7d515ff3-fb50-4129-8d0f-cde4336c7327", "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": "20160106", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Quality Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "carton.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "780a7447-63f9-4126-985e-5afa0a942cc5", "id": "28b21bb0-32b1-0954-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20150107", "purpose": [ "Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 15 mg Cough Suppressant Pseudoephedrine HCl 30 mg Decongestant Guaifenesin 211 mg 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. 1-800-222-1222" ], "when_using": [ "may cause excitability, or increased irritability especially in children" ], "questions": [ "Questions? Call 1-800-793-2145" ], "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 20°-25°C (68°-77°F) Tamper Evident: Do not use if seal is broken or missing." ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep nasal congestion due to the common cold promotes nasal and/or sinus drainage" ], "set_id": "78b637b1-59d7-4d77-96ee-5ad58582091f", "id": "41970b08-5b89-4834-9e23-3d2557072a5d", "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 15 mg Cough Suppressant Pseudoephedrine HCl 30 mg Decongestant Guaifenesin 211 mg Expectorant" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and older 2 teaspoonfuls
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age Ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Acesulfame K, Artificial Grape Flavor, Aspartame, Bitter Mask, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Xanthan Gum." ], "warnings": [ "Warnings may cause excitability, or increased irritability especially in children 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 diabetes thyroid disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble with urination due to enlargement of the prostate gland cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not get better within 7 days, come back or occur with a 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 right away. 1-800-222-1222" ], "spl_product_data_elements": [ "Z-COF 1 DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM GRAPE ASPARTAME CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN METHYLPARABEN MAGNESIUM ALUMINUM SILICATE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble with urination due to enlargement of the prostate gland cough accompanied by too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take every 8 hours do not take more than 3 doses in 24 hours or as directed by a doctor Adults and children 12 years of age and older 2 teaspoonfuls Children 6 to under 12 years of age 1 teaspoonful Children under 6 years of age Ask a doctor" ], "package_label_principal_display_panel_table": [ "
Dextromethorphan Hydrobromide 15mg
Pseudoephedrine Hydrochloride 30mg
Guaifenesin 211mg
" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness." ], "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 5 mL) Purpose
Dextromethorphan HBr 15 mg Cough Suppressant
Pseudoephedrine HCl 30 mg Decongestant
Guaifenesin 211 mg Expectorant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 65224-618-16 PERNIX THERAPEUTICS Z-Cof ™ 1 Antitussive/Decongestant/ Expectorant GRAPE FLAVOR Alcohol Free Each 5 mL (one teaspoonful) for oral administration contains: Dextromethorphan Hydrobromide 15mg Pseudoephedrine Hydrochloride 30mg Guaifenesin 211mg Shake well 16 fl. oz. (473 mL) Principal Display Panel - 473 mL Bottle Label" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 15 mg Cough Suppressant
Pseudoephedrine HCl 30 mg Decongestant
Guaifenesin 211 mg Expectorant
" ] }, { "effective_time": "20151216", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Western Family Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "78e825d5-1ead-4d5b-9892-22b5a3ae4045", "id": "27085794-ae3d-6faf-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20100308", "inactive_ingredient": [ "Ascorbic Acid, Aspartame, Citric Acid, Pineapple Flavor, Colorants Red No. 40, Eucalyptus Oil, Hyssop, Large leaf Geiger Tree, Lesser Galangal, Licorice, Liquid Glucose, Long Pepper, Malabar Nut, Sweet Violet" ], "purpose": [ "Cough Suppresant, Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly. These may be serious." ], "questions": [ "Questions or comments: 1-888-654-3724 Monday thru Friday, 9am-5pm or visit www.Herbion.com" ], "spl_product_data_elements": [ "Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol MENTHOL MENTHOL NONE" ], "description": [ "Other Information: store in a cool, dry place, below 25 degrees C Protect from heat and light Diabetic patients should not use linkus lozenges without the advice of physician and they should monitor glucose levels closely while taking lozenges as it may alter blood glucose levels Manufactured for: Herbion USA Inc. Williamsville NY 14221 1-888-(OK-HERBION)-654-3724 info.us@herbion.com www.herbion.com" ], "ask_doctor": [ "Ask a doctor before use if you have: A persistent or chronic cough such as occurs with smoking, asthma, emphysema A cough that is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and over Take 1-2 lozenges every 2 to 3 hours not more than 8 lozenges in 24 hours Children 6 years to under 12 years Take 1 lozenge every 5 to 6 hours not more than 4 lozenges in 24 hours Children under 6 years of age Consult your 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: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persisted headache. These could be signs of a serious condition Sore throat symptoms do not improve in 7 days Irritation, pain or redness persists or worsens" ], "package_label_principal_display_panel": [ "Linkus Lozenges Sugar Free Cough Suppresant Oral Anesthetic Relieves Cough and Soothes Sore Throat Pineapple Linkus Lozenges Pineapple Front Label Linkus Lozenges Pineapple Back Label" ], "indications_and_usage": [ "Uses: Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold For temporary relief of occasional minor irritation, pain, sore mouth and sore throat" ], "set_id": "79b92dec-8b7a-49aa-9a84-dcf2370221d6", "id": "1ea9092b-5431-4031-9e9d-8dbd26215658", "active_ingredient": [ "Menthol 5.2mg" ] }, { "effective_time": "20120121", "inactive_ingredient": [ "Inactive Ingredients: Aspartame, + citric acid, FD&C Yellow #6 Lake, Maltodextrin, Orange Flavor and Sodium Lauryl Sulfate." ], "purpose": [ "Dosage Adults 12 years & older: 1 rounded TEASPOON in 8 oz of liquid 3 times daily. Children under 12 years: Consult a doctor. Notice Take this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See warnings . ** Percent Daily Values (DV) are based on a 2,000 Calorie Diet. † Daily Value (DV) not established. Supplement Facts Serving Size 1 rounded teaspoon (5.8g) Servings Per Container 48 Amount Per Serving %DV Calories 20 Sodium 5 mg <1% ** Total Carbohydrates 5 g 2% ** Dietary Fiber 3 g 12% ** Soluble Fiber 2 g † Sugars 0 g † Calcium 7 mg <1% ** Iron 1 mg 4% ** Psyllium Hydrophilic Mucilloid 3.4 g † Inactive Ingredients Aspartame, + citric acid, FD&C Yellow #6 Lake, Maltodextrin, Orange Flavor and Sodium Lauryl Sulfate. +Contains Phenylalanine 6 mg. per teaspoon Fiber Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. TAKING THIS PRODUCT WITHOUT ADEQUATE FLUID MAY CAUSE IT TO SWELL AND BLOCK YOUR THROAT OR ESOPHAGUS AND MAY CAUSE CHOKING. DO NOT TAKE THIS PRODUCT IF YOU HAVE DIFFICULTY IN SWALLOWING. IF YOU EXPERIENCE CHEST PAIN, VOMITING, OR DIFFICULTY IN SWALLOWING OR BREATHING AFTER TAKING THIS PRODUCT, SEEK IMMEDIATE MEDICAL ATTENTION. May cause allergic reaction in people sensitive to inhaled or ingested psyllium. Store at room temperature, USP. *This product is not manufactured or distributed by Procter & Gamble, distributor of Metamucil®." ], "warnings": [ "Warnings DO NOT USE THIS PRODUCT FOR A PERIOD LONGER THAN ONE WEEK. CONSULT A DOCTOR IF YOU HAVE RECTAL BLEEDING OR FAIL TO HAVE A BOWEL MOVEMENT AS IT MAY BE A SIGN OF A MORE SERIOUS CONDITION. Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 NOTE SEPARATE USES Directions Put one does into an empty glass. Fill glass with at least 8 oz of water or your favorite beverage. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. MIX THIS PRODUCT (CHILD OR ADULT DOSE) WITH AT LEAST 8 OZ (A FULL GLASS) OF WATER OR OTHER LIQUID. TAKING THIS PRODUCT WITHOUT ENOUGH LIQUID MAY CAUSE CHOKING. SEE WARNINGS . Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. Warnings Before using this product, consult a doctor if you: have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea, vomiting or rectal bleeding are considering use of this product as part of a cholesterol-lowering program." ], "spl_product_data_elements": [ "SUGAR FREE PSYLDEX Psyllium Husks PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 MALTODEXTRIN LACTOSE ORANGE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) RAW SUGAR CARBOXYMETHYLCELLULOSE PROPYLENE GLYCOL ALGINATE BUTYLATED HYDROXYANISOLE COW MILK ORANGE JUICE BENZYL ALCOHOL pale orange" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Dosage Adults 12 years & older: 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours. Children 6 to under 12 years: 1/2 adult dose in 8 oz of liquid, up to 3 times daily. Children under 6 years: Consult a doctor." ], "spl_unclassified_section": [ "NATURAL VEGETABLE LAXATIVE ORANGE FLAVOR SUGAR FREE A natural non-irritating bulk-producing dietary fiber which promotes relief of constipation. Contains no chemical stimulants. When recommended by a physician, is useful in the treatment of bowel disorders other than constipation. Approximately 20 calories per dose and less than 0.004 gram of sodium. SUGAR FREE PSYLDEX BRAND OF PSYLLIUM HYDROPHILIC MUCILLOID SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. READ ENTIRE LABEL INCLUDING WARNINGS. DIETARY FIBER SUPLEMENT" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL e5db613b-figure-01" ], "indications_and_usage": [ "Uses Effective in treating occasional constipation and restoring regularity. Contains 100% natural therapeutic fiber." ], "set_id": "7ae02e8c-9385-4fcf-9054-18d2167bc29e", "id": "e5db613b-7f6b-4a9b-ad6b-438f2715b39a", "purpose_table": [ "
**Percent Daily Values (DV) are based on a 2,000 Calorie Diet.
†Daily Value (DV) not established.
Supplement Facts Serving Size 1 rounded teaspoon (5.8g) Servings Per Container 48
Amount Per Serving %DV
Calories 20
Sodium 5 mg <1%**
Total Carbohydrates 5 g 2%**
Dietary Fiber 3 g 12%**
Soluble Fiber 2 g †
Sugars 0 g †
Calcium 7 mg <1%**
Iron 1 mg 4% **
Psyllium Hydrophilic Mucilloid 3.4 g †
" ], "active_ingredient": [ "Active ingredient: Approximately 3.4 g of psyllium husk per dose." ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, microcrystalline cellulose, silicon dioxide" ], "purpose": [ "Purpose Upset stomach reliever/Antidiarrheal" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding , ask a health professional before use." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or 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: Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding , ask a health professional before use." ], "questions": [ "Questions or comments? 1-800-234-1464" ], "spl_product_data_elements": [ "Moore Medical Bismuth BISMUTH SUBSALICYLATE ASPARTAME CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE SILICON DIOXIDE BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID pink ROUND RH;046" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed chew or dissolve in mouth use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets (4,200mg) in 24 hours Adults and children: (12 years and older) Take 2 tablets (524mg) every 1/2 to 1 hour or 4 tablets (1,048mg) every hour as needed 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." ], "spl_unclassified_section": [ "Drug Facts", "Other information phenylketonurics: contains phenylalanine 1.1mg per tablet each tablet contains 73mg elemental calcium store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena." ], "do_not_use": [ "Do not use if you have bloody or black stool an ulcer a bleeding problem" ], "package_label_principal_display_panel": [ "220R MM Bismuth Label moore medical Supporting Health and Care UPN# 0-0607415-82473-5 Moore Brand® Bismuth Tablets 100 Packets/2 Tablets Each Packet Net Wt. 1000 mg Controls diarrhea within 24 hours, relieving associated abdominal cramps; provides soothing relief for: indigestion, upset stomach, heartburn and nausea. Reorder No.: 82473 To Reorder: Call: 1.800.234.1464 Fax: 1.800.944.6667 Online: www.mooremedical.com 220R MM Bismuth Label" ], "indications_and_usage": [ "Uses Temporarily relieves traveler's diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness" ], "set_id": "7bd8398c-7c35-4230-92a4-32945078a25a", "id": "07d364f3-b332-421b-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Bismuth Subsalicylate 262mg" ] }, { "effective_time": "20120914", "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 QC QUALITY CHOICE ® NDC 63868-0157-10 † Compare to the active ingredient in Claritin ® Reditabs ® NON-DROWSY ٭٭ Original Prescription Strength 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; Itchy Throat or Nose 10 Orally Disintegrating Tablets 24 Hour Allergy Relief ٭٭ When taken as directed. See Drug Facts Panel. © DISTRIBUTED BY QUALITY CHOICE 5079372/R0610 This is the 10 count blister carton label for Quality Choice 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": "7cc8edff-b6fb-4a5f-8053-ebfdd0f8e770", "id": "f1415ccc-2075-46be-9778-002df4ea835d", "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": "20121226", "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 use more than directed. Taking more than recommended may cause drowsiness." ], "questions": [ "Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Phenylketonurics : Contains Phenylalanine 8.4 mg per tablet store at 20-25°C (68-77°F) keep in a dry place" ], "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": "7f4ecbce-74f7-4dfe-8c7d-7703458fdbb1", "id": "d8fd80c9-b8a2-4427-8636-6db06d0fc2ee", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
adults and children 6 years and over 1 tablet daily, do not use more than 1 tablet daily
children under 6 ask a doctor
consumers who have liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial & natural flavor, aspartame, citric acid, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate" ], "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 use more than directed. Taking more than recommended 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": [ "Alavert Allergy Loratadine Loratadine Loratadine off white beveled A;24" ], "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 tablet melts in mouth. Can be taken with or without water Age Dose adults and children 6 years and over 1 tablet daily, do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 ©2006 www.alavert.com" ], "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" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 1 Tablet Carton MELTS IN YOUR MOUTH! Same Fresh Mint Flavor! allergy ALAVERT ® Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine Non-Drowsy* Allergy Relief 24 HOUR Relief of Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat Original Flavor 1 Orally Disintegrating Tablet *When taken as directed. See Drug Facts Panel. 1 Orally Disintegrating TABLET THE ORIGINAL Lil' Drug Store ® PRINCIPAL DISPLAY PANEL - 1 Tablet Carton" ] }, { "effective_time": "20140923", "inactive_ingredient": [ "Inactive ingredients aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor" ], "purpose": [ "Purpose Fiber therapy for regularity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away." ], "warnings": [ "Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away." ], "questions": [ "Questions? 1-800-983-4237" ], "spl_product_data_elements": [ "Metamucil Therapy for Regularity Psyllium Husk Metamucil Therapy for Regularity Psyllium Husk Psyllium Husk Psyllium Husk citric acid monohydrate FD&C Yellow No. 6 sucrose Metamucil Therapy for Regularity Psyllium Husk Psyllium Husk Psyllium Husk citric acid monohydrate FD&C Yellow No. 6 sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits persisting for 2 weeks abdominal pain, nausea or vomiting" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 - 72 hours. 6 - 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. New Users Start with 1 dose per day; gradually increase to 3 doses per day as necessary." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These may be signs of a serious condition." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 30 mg; sodium 5 mg PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon store at room temperature tightly closed to protect from humidity see bottom of canister for expiration date contains a 100% natural, therapeutic fiber" ], "do_not_use": [ "Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 1.32 kg Canister Label Sugar-free Not a low calorie product. Metamucil ® MultiHealth Fiber ✔ Helps lower cholesterol to promote heart health* ✔ Promotes digestive health † ✔ Low glycemic index* † ✔ Gluten free (less than 20 ppm gluten)* 100% Natural Psyllium Daily fiber supplement/ Therapy for regularity 228 DOSES 2 x 114 Doses P&G WORLDWIDE PARTNER Orange smooth Psyllium fiber powder/Naturally and artificially flavored NET WT 46.6 OZ (2.8 LBS) 1.32 kg 2 - 114 DOSES (228 DOSES TOTAL) *See back for information about soluble fiber and heart disease and for information about low glycemic index and gluten. PRINCIPAL DISPLAY PANEL - 1.32 kg Canister Label" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "7fb350de-624d-4765-a777-6c7efebd2b28", "id": "f6018149-71dc-460f-8ebd-a787def4cfb6", "active_ingredient": [ "Active ingredient (in each TEASPOON) Psyllium husk approximately 3.4 g" ], "dosage_and_administration_table": [ "
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 - 72 hours.
6 - 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily
Under 6 yrs. Consult a doctor
" ] }, { "spl_product_data_elements": [ "Diabetic Maximum Strength Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACESULFAME POTASSIUM ASPARTAME BENZOIC ACID HYPROMELLOSE 2910 (4000 MPA.S) METHYLPARABEN PROPYLENE GLYCOL ANHYDROUS CITRIC ACID WATER strawberry flavor" ], "active_ingredient": [ "Active Ingredient: Guaifenesin 200 mg (in each 5 mL) Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL)" ], "purpose": [ "Purpose of Guaifenesin: Expectorant Purpose of Dextromethorphan Hydrobromide: Cough Suppressant" ], "indications_and_usage": [ "Uses ■ temporarily relieves cough due to minor throat and bronchial irritation ■ helps loosen phlegm (mucus) ■ thin bronchial secretions to make coughs more productive" ], "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 ■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema ■ cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if ■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition ■ hypersensitive to any ingredients 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." ], "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." ], "ask_doctor": [ "Ask a doctor before use if you have ■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema ■ cough accompanied by excessive phlegm (mucus)" ], "stop_use": [ "Stop use and ask a doctor if ■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition ■ hypersensitive to any ingredients" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "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." ], "dosage_and_administration": [ "Directions take every 4 hours, or as directed by a doctor, not more than 6 doses in 24 hours Adult and children 12 years and over 2 teaspoonfuls (10 mL) Children under 12 years DO NOT USE" ], "dosage_and_administration_table": [ "
Adult and children 12 years and over 2 teaspoonfuls (10 mL)
Children under 12 years DO NOT USE
" ], "inactive_ingredient": [ "Inactive ingredients Acesulfame-K, aspartame, benzoic acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water. May contain citric acid." ], "spl_unclassified_section": [ "Other information ■ store at room temperature 20°-25°C (68°-77°F) ■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)" ], "questions": [ "Questions 888-974-5279 *This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributor of Robitussin®-DM. Manufactured by: Silarx Pharmaceuticals, Inc 1033 Stoneleigh Ave. Carmel, NY 10512 USA" ], "package_label_principal_display_panel": [ "Container Label" ], "set_id": "80b0a591-7e5b-4e47-b96e-8aa888ea1c76", "id": "f4311b8a-2123-47f0-8089-16ad5e0db3c8", "effective_time": "20140627", "version": "14", "openfda": {} }, { "effective_time": "20141114", "inactive_ingredient": [ "Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, microcrystalline cellulose, silicon dioxide" ], "purpose": [ "Purpose Upset stomach reliever/antidiarrheal" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or 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: Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena." ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "Medique Diotame BISMUTH SUBSALICYLATE ASPARTAME CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE SILICON DIOXIDE BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID pink ROUND RH;046" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed chew or dissolve in mouth use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets (4,200mg) in 24 hours Adults and children: (12 years and older) Take 2 tablets (525mg) every 1/2 to 1 hour or 4 tablets (1,050mg) every hour as needed 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." ], "spl_unclassified_section": [ "Drug Facts", "Other information phenylketonurics: contains phenylalanine 1.1mg per tablet each tablet contains 73mg elemental calcium store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. If pregnant or breast-feeding, ask a health professional before use." ], "do_not_use": [ "Do not use if you have bloody or black stool an ulcer a bleeding problem" ], "package_label_principal_display_panel": [ "220R Medique Diotame Label Medique ® Diotame Bismuth Subsalicylate Indigestion •Upset Stomach •Heartburn Diarrhea •Nausea Pull To Open Chewable Tablets 100 Tablets (50 x 2) Tamper Evident Unit Dose Packets 220R Medique Diotame Label" ], "indications_and_usage": [ "Uses Temporarily relieves traveler's diarrhea diarrhea upset stomach reliever due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness" ], "set_id": "812bf7a4-0d90-4935-aaef-58b2f7e27059", "id": "07d585ce-389d-349a-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Bismuth Subsalicylate 262 mg" ] }, { "effective_time": "20100716", "purpose": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg 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." ], "when_using": [ "When using this product do not exceed recommended dosage may cause marked drowsiness 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" ], "questions": [ "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not 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." ], "storage_and_handling": [ "Other information each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet store at room temperature. Avoid excessive heat." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains sinus congestion and pressure sore throat headache cough nasal congestion runny nose sneezing temporarily reduces fever" ], "set_id": "836c1bf4-7aec-4541-94ee-921659192cb3", "id": "297274bc-2bce-44ae-ad25-291ab2b9bbe9", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "warnings": [ "Warnings Reye's syndrome Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. 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 to sedate children. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning) diabetes gout arthritis taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness 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 Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not 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. 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": [ "Alka-Seltzer Plus Night Cold Medicine Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide Aspirin Aspirin Doxylamine succinate Doxylamine Phenylephrine bitartrate Phenylephrine Dextromethorphan hydrobromide Dextromethorphan A;S;NT" ], "ask_doctor": [ "Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back bleeding problems ulcers asthma heart disease high blood pressure diabetes thyroid disease glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain, cough, 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs" ], "do_not_use": [ "Do not use to sedate children.", "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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. in children under 12 years of age" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipper Label ALKA-SELTZER PLUS ® NIGHT COLD FORMULA 3200 TABLETS 1600 PIECES SHIPPER CODE 1 00 16500 54213 8 MADE IN MEXICO PRODUCT CODE 82411594 STORE AT ROOM TEMPERATURE. AVOID EXCESSIVE HEAT Bayer HealthCare LLC Consumer Care P.O. Box 1910, Morristown, NJ 07962-1910 USA Principal Display Panel – Shipper Label" ], "purpose_table": [ "
Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant
" ] }, { "effective_time": "20140824", "inactive_ingredient": [ "INACTIVE INGREDIENT acesulfame potassium, aspartame, citric acid anhydrous, color ponceau 4r, isopropyl alcohol, mannitol, orange flavor, pvp k-30, Simethicone, sodium benzoate, sodium bicarbonate, sodium saccharin, tween 80." ], "purpose": [ "Purpose pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than recommended dose (overdose) may cause liver damage. 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." ], "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 maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children. do not use: with any other drug containing acetaminophen (prescription or not prescription). 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 Thyroid disease Diabetes High blood pressure Glaucoma Cough with excessive phlegm (mucus) A breathing problem such as emphysema or chronic bronchitis Difficulty in urinating due to enlargement of prostate gland Persistent or chronic cough such as occurs with smoking, asthma or emphysema A sodium restricted diet ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. taking sedative or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedative and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur especially in children Stop use and ask a doctor if pain, cough 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 cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition. Nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use" ], "questions": [ "QUESTIONS Call toll free 1-855-314-1850 Distributed by Velocity Pharma Llc" ], "spl_product_data_elements": [ "Pain Reliever Fever Reducer Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID PONCEAU 4R ISOPROPYL ALCOHOL MANNITOL ORANGE POVIDONE K30 DIMETHICONE SODIUM BENZOATE SODIUM BICARBONATE SACCHARIN SODIUM POLYSORBATE 80" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Direction do not take more than the recommended dose Adults and children 12 years and over: 2 tablets fully dissolved in 4 oz of water every 4 hours, Do not exceed 8 tablets in 24 hours or as directed by a doctor children under 12 years: do not use" ], "spl_unclassified_section": [ "Other Information phenylketonurics: contains phenylalanine 15 mg per tablet store at room temperature , avoid excessive heat. Total sodium : 415 mg/tablet Total potassium: 1mg /tablet" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 76168-021-13 6 tablets 240453b0-figure-01" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to cold or flu: Minor aches and pains Headaches Cough Sore throat Runny nose Sneezing Nasal and sinus congestion Temporarily reduces fever" ], "set_id": "8600db56-a877-4557-ab71-d46b72d642c9", "id": "240453b0-189a-401e-9f2e-2bf977f7aaa6", "active_ingredient": [ "Active Ingredient (in each tablet) Acetaminophen 250 mg Chlorpheniramine Maleate 2mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20120430", "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. (1-800-222-1222)" ], "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" ], "questions": [ "Questions or comments? call 1-800-382-7219" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information Phenylketonurics: contains phenylalanine 0.84 mg per tablet store between 20–25°C (68–77°F) do not use if carton is opened or if blister unit is broken or torn see side panel for lot number and expiration date" ], "indications_and_usage": [ "Use for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness" ], "set_id": "88c564ee-3687-4c5c-8dd1-65857dec3621", "id": "f1dc68e5-01c4-456e-97f0-0776308a78a3", "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" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 2 chewable tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years give ½ to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years give ½ chewable tablet every 6-8 hours do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol" ], "warnings": [ "Warnings Do not use for children under 2 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 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": [ "Dramamine Chewable Formula Dimenhydrinate Dimenhydrinate Dimenhydrinate anhydrous citric acid aspartame FD&C yellow no. 6 aluminum oxide magnesium stearate maltodextrin sorbitol Circular Flat Faced Tablet DRAMAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over take 1 to 2 chewable tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor children 6 to under 12 years give ½ to 1 chewable tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor children 2 to under 6 years give ½ chewable tablet every 6-8 hours do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "do_not_use": [ "Do not use for children under 2 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-310-08 Dimenhydrinate Tablets/Antiemetic Dramamine ® CHEWABLE FORMULA Convenient Chewable Tablets For Children and Adults. 8 ORANGE FLAVOR TABLETS (50 mg EACH) Principal Display Panel" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, silicon dioxide, Sodium Citrate, Starch, Sucrose." ], "purpose": [ "Uses - Temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly." ], "spl_product_data_elements": [ "Well At Walgreens Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon Flavor Caramel color D and C Yellow No. 10" ], "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 occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "- do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - If you are allergic to acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg. - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "8ae4d78c-835e-44e2-bd25-0e49595b0c40", "id": "267a19ca-b39e-05b8-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Multi-Symptom Severe Cold with Green Tea and Honey Lemon flavors Active ingredients (in each packet) Purpose Acetaminophen 500 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ] }, { "effective_time": "20150930", "inactive_ingredient": [ "Also contains aspartame, citric acid, colloidal silicon dioxide, croscarmellose sodium, dextrose, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, sorbitol and stearic acid." ], "contraindications": [ "CONTRAINDICATIONS Hypersensitivity to any of the ingredients." ], "purpose": [ "PINWORM TREATMENT" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a doctor. If you are pregnant or have liver disease, do not take this product unless directed by a doctor." ], "precautions": [ "PRECAUTION Information for Patients Phenylketonurics Pin-X ® Chewable Tablets contain phenylalanine 11.8 mg per tablet." ], "warnings": [ "WARNINGS KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist, consult a doctor. If you are pregnant or have liver disease, do not take this product unless directed by a doctor." ], "spl_product_data_elements": [ "Pin X pyrantel pamoate PYRANTEL PAMOATE PYRANTEL ASPARTAME CITRIC ACID MONOHYDRATE SILICON DIOXIDE CROSCARMELLOSE SODIUM DEXTROSE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN SORBITOL STEARIC ACID PIN;X" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "DIRECTIONS FOR USE Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken one time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See WARNINGS . If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor. This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication. Adults and children 2 years to under 12 years of age: oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight not to exceed 1 gram. Dosage information is summarized on the following schedule: Weight Dosage (taken as a single dose) Less than 25 pounds (11 kg) or under 2 years old Do not use unless directed by a doctor 25 to 37 pounds (11 to 16 kg) 1/2 tablet 38 to 62 pounds (17 to 28 kg) 1 tablet 63 to 87 pounds (29 to 39 kg) 1 1/2 tablets 88 to 112 pounds ( 40 to 50 kg) 2 tablets 113 to 137 pounds (51 to 62 kg) 2 1/2 tablets 138 to 162 pounds (63 to 73 kg) 3 tablets 163 to 187 pounds (74 to 84 kg) 3 1/2 tablets over 187 pounds (over 84 kg) 4 tablets" ], "spl_unclassified_section": [ "Symptoms suggestive of pinworm infestation: Pruritis Ani (itching in the anal area), insomnia, gastrointestinal distress, irritability, enuresis (bed wetting) and secondary infection due to localized scratching are symptoms of pinworms. However, you should make a visual inspection and confirmation of the pinworms before using this product.", "How to find and identify the pinworm: A pinworm is a small round worm that lives in the body of other animals. They are 1/4 to 1/2 inch long and have white bodies and pointed tails. There are several kinds of pinworms, however, only one kind, Enterobius vermicularis, commonly infects human beings. The worms can usually be detected during the hours of sleep when the worm migrates out of the anus onto the surrounding skin.", "The life cycle of the pinworm: The young worms live in the upper part of the large intestine. When they are ready to lay eggs, they crawl down the rectum and out the intestinal opening called the anus, usually at night. They lay eggs on the surrounding skin. This movement causes swelling and severe itching.", "How pinworms are spread and how to avoid spreading: The eggs fall off into the bedding or clothing and may be picked up under the fingernails in scratching. If the eggs are swallowed, they reach the intestine and become adult pinworms. Therefore, to avoid the spreading of pinworms all areas should be as clean as possible.", "Distributed by: QUARTZ SPECIALTY PHARMACEUTICALS, LLC 130 Vintage Drive Huntsville, Alabama 35811 8182505 Rev 12/10 R2" ], "storage_and_handling": [ "Store at 15°-30°C (59°-86°F)." ], "how_supplied": [ "HOW SUPPLIED Pin-X ® Chewable Tablets are supplied as round, flat faced, orange color, orange flavored chewable tablets with “Pin-X” debossed over a score line on one side and plain on the reverse side, in bottles of 12. Store at 15°-30°C (59°-86°F)." ], "information_for_patients": [ "Information for Patients Phenylketonurics Pin-X ® Chewable Tablets contain phenylalanine 11.8 mg per tablet.", "Phenylketonurics Pin-X ® Chewable Tablets contain phenylalanine 11.8 mg per tablet." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image of the Chewable Pin-X Tablets label.", "PRINCIPAL DISPLAY PANEL Image of the Chewable Pin-X Tablets carton." ], "indications_and_usage": [ "INDICATIONS AND USAGE For the treatment of pinworms." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Pin-X ® has demonstrated anthelmintic activity against Enterobius vermicularis (pinworm) and Ascaris lumbricoides (common roundworm). The anthelmintic action is probably due to the neuromuscular blocking property of the drug. Pin-X ® is partially absorbed after an oral dose. Plasma levels of unchanged drug are low. Peak levels (0.05 - 0.13 micrograms per milliliter) are reached in 1-3 hours. Quantities greater than 50% of administered drug are excreted in feces as the unchanged form, whereas only 7% or less of the dose is found in urine as the unchanged form of the drug and its metabolites." ], "set_id": "8c37db7c-a73e-4d99-a8a9-d55da1a74a3e", "id": "b5619010-12c1-48b6-bf7c-ad226688b5de", "active_ingredient": [ "DESCRIPTION Each chewable tablet for oral administration contains: Pyrantel pamoate ..................................720.5 mg (equivalent to 250 mg pyrantel base)" ], "dosage_and_administration_table": [ "
Weight Dosage (taken as a single dose)
Less than 25 pounds (11 kg) or under 2 years old Do not use unless directed by a doctor
25 to 37 pounds (11 to 16 kg) 1/2 tablet
38 to 62 pounds (17 to 28 kg) 1 tablet
63 to 87 pounds (29 to 39 kg) 1 1/2 tablets
88 to 112 pounds ( 40 to 50 kg) 2 tablets
113 to 137 pounds (51 to 62 kg) 2 1/2 tablets
138 to 162 pounds (63 to 73 kg) 3 tablets
163 to 187 pounds (74 to 84 kg) 3 1/2 tablets
over 187 pounds (over 84 kg) 4 tablets
" ] }, { "effective_time": "20130321", "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 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 SHOPKO ® † Compare to the Active Ingredient of Claritin ® RediTabs ® Original Prescription Strength Allergy Relief Loratadine Orally Disintegrating Tablets, USP 10 mg Antihistamine Non-Drowsy * Indoor & Outdoor Allergies 24 Hour Allergy Relief For Adults and Children six years and older! Relief of: Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose • No Water Needed • Melts in Your Mouth * When taken as directed. See Drug Facts Panel. Manufactured by: Ohm Laboratories Inc. 5093689/R0512 30's blister 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": "8d7cedb3-6edc-4e9d-9f18-08158d176fdd", "id": "03adedd8-1cda-4e10-a2a2-5680a260809e", "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": "20120126", "inactive_ingredient": [ "Inactive ingredients aspartame*, corn starch*, croscarmellose sodium*, D&C yellow #10*, FD&C blue #1*, magnesium stearate, mint flavor, silicon dioxide*, sorbitol*, starch*, sucrose* *may contain" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "warnings": [ "Warnings Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet Stop using this product and ask a doctor if symptoms last more than 2 weeks Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "questions": [ "Questions or comments Call 1-800-835-2263" ], "spl_product_data_elements": [ "Physicians Care Antacid calcium carbonate Calcium Carbonate Calcium Cation Carbonate Ion D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE SILICON DIOXIDE STARCH, CORN SUCROSE white ROUND FR8 MINT" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 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 physician. Children under 12 years: Do not give to children under 12 years of age." ], "spl_unclassified_section": [ "Drug Facts", "Other information Phenylketonurics: contains phenylalanine 1.5 mg per tablet each tablet contains 168 mg of elemental calcium store at room temperature 59º-86º F (15º-30º C) in a dry place tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using this product and ask a doctor if symptoms last more than 2 weeks" ], "package_label_principal_display_panel": [ "Principal Display Panel - 101R Physicians Care Antacid Label Physicians Care® Antacid Calcium Carbonate Pull To Open Chewable Tablets Compare active ingredient to: TUMS® Registered Trademark of GlaxoSmithKline Consumer Healthcare, LP Tamper-Evident Packets of 2 Tablets Physicians Care® Registered trademark of Acme United Corporation 50 Packets (2 Tablets 420 Mg Each) Principal Display Panel - 101R Physicians Care Antacid Label" ], "indications_and_usage": [ "Uses For the relief of the following symptoms associated with acid indigestion sour stomach heartburn upset stomach" ], "set_id": "8ec8db2e-ffe3-4f3d-8b90-3e4fca7dc9be", "id": "d025c656-b253-4f0a-b4c9-e08d408a7ddb", "ask_doctor_or_pharmacist": [ "Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet" ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium Carbonate 420 mg" ] }, { "effective_time": "20120910", "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 mouth or throat burning may occur; give with food or water 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? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information phenylketonurics: contains phenylalanine 2.8 mg per tablet store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "96d674d8-c4d2-49a4-b372-95a7f4ffe9ea", "id": "2073e5a2-1419-4bfe-b888-866a82703e6a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Tablets
under 24 under 2 ask a doctor
24 - 35 2 - 3 1
36 - 47 4 - 5 1 1/2
48 - 59 6 - 8 2
60 - 71 9 - 10 2 1/2
72 - 95 11 3
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C red #7 calcium lake, D&C red #30 aluminum lake, FD&C blue #1 aluminum lake, flavor, fumaric acid, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate" ], "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 your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has 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 your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product mouth or throat burning may occur; give with food or water 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 child experience any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear 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": [ "Motrin Junior Strength Ibuprofen Ibuprofen ibuprofen acesulfame potassium anhydrous citric acid aspartame D&C red no. 30 FD&C blue no. 1 aluminum oxide fumaric acid hypromelloses magnesium stearate mannitol cellulose, microcrystalline povidones sodium lauryl sulfate Sodium Starch Glycolate Type A Potato MO;100" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24 - 35 2 - 3 1 36 - 47 4 - 5 1 1/2 48 - 59 6 - 8 2 60 - 71 9 - 10 2 1/2 72 - 95 11 3" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experience any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has 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 See New Warnings Information NDC 50580-909-24 Motrin ® Junior Strength For Ages 2 to 11 Lasts up to 8 hours contains Ibuprofen Tablets (NSAID), 100 mg Pain Reliever / Fever Reducer 24 Grape-Flavored Chewable Tablets PRINCIPAL DISPLAY PANEL" ] }, { "effective_time": "20120831", "inactive_ingredient": [ "Inactive ingredients: acesulfame potassium, aspartame, citric acid, docusate sodium, mannitol, povidone, sodium benzoate, sodium bicarbonate" ], "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." ], "purpose": [ "Fast Relief of: Nasal Congetion, Runny Nose, Sneezing, Headache, Sinus Pain and Pressure" ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert: Aspirin may cause a server allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock 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 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. 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." ], "when_using": [ "When using this product : - do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor. - do not use more than directed - you may get drowsy - avoid alcoholic drinks - 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": [ "Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE ASPIRIN ASPIRIN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE BITARTRATE PHENYLEPHRINE ACESULFAME POTASSIUM ASPARTAME CITRIC ACID MONOHYDRATE DOCUSATE SODIUM MANNITOL POVIDONE K30 SODIUM BENZOATE SODIUM BICARBONATE N&A Lemon Lime Flavor FAKP193 CF" ], "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 - glaucome - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis - you are taking a diuretic - been placed on a sodium-restricted diet." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions - do not use more than directed (see overdose warning) - adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours - do not take more than 8 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. It is especially important not 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." ], "adverse_reactions": [ "Adverse Event Reporting: Serious side effects associated with the use of this product can be reported to the following address or by calling the following telephone number." ], "stop_use": [ "Sto p use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody stools - have stomach pain that does not get better - an allergic reaction occurs, seek medical help right away. - pain or nasal congestion gets worse or lasts more than 7 days. - fever gets worse or lasts more than 3 days. - new symptoms occur - redness or swelling is present - ringing in the ears or loss of hearing occurs - nervousness, dizziness or sleeplessness occurs." ], "do_not_use": [ "Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - 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": [ "image of carton" ], "indications_and_usage": [ "Uses: temporarily relieves these symptoms of the common cold: - fever - sneezing - nasal congestion - sore throat - headache - minor aches and pains - runny nose - sinus congestion and pressure" ], "set_id": "9b1ec246-aec2-4279-baf5-43e63e3c0be1", "id": "b3d1e541-da02-4735-81be-b4a45f045c7b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are: - presently taking a prescription drug. - taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis." ], "active_ingredient": [ "Active Ingredients (in each effervescent tablet) Purpose Aspirin 325 mg NSAID *.......................................... Pain reliever/fever reducer Chlorpheniramine maleate 2 mg ............................... Antihistamine Phenylephrine Bitartrate 7.8 mg ............................... Nasal decongestant *Nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100308", "inactive_ingredient": [ "Ascorbic Acid, Aspartame, Colorants Red No. 40, Eucalyptus Oil, Hyssop, Large leaf Geiger Tree, Lesser Galangal, Licorice, Liquid Glucose, Long Pepper, Malabar Nut, Strawberry Flavor, Sweet Violet" ], "purpose": [ "Cough Suppresant, Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly. These may be serious." ], "questions": [ "Questions or comments: 1-888-654-3724 Monday thru Friday, 9am-5pm or visit www.Herbion.com" ], "spl_product_data_elements": [ "Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol MENTHOL MENTHOL NONE" ], "description": [ "Other Information: store in a cool, dry place, below 25 degrees C Protect from heat and light Diabetic patients should not use linkus lozenges without the advice of physician and they should monitor glucose levels closely while taking lozenges as it may alter blood glucose levels Manufactured for: Herbion USA Inc. Williamsville NY 14221 1-888-(OK-HERBION)-654-3724 info.us@herbion.com www.herbion.com" ], "ask_doctor": [ "Ask a doctor before use if you have: A persistent or chronic cough such as occurs with smoking, asthma, emphysema A cough that is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and over Take 1-2 lozenges every 2 to 3 hours not more than 8 lozenges in 24 hours Children 6 years to under 12 years Take 1 lozenge every 5 to 6 hours not more than 4 lozenges in 24 hours Children under 6 years of age Consult your 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: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persisted headache. These could be signs of a serious condition Sore throat symptoms do not improve in 7 days Irritation, pain or redness persists or worsens" ], "package_label_principal_display_panel": [ "Linkus Lozenges Sugar Free Cough Suppresant Oral Anesthetic Relieves Cough and Soothes Sore Throat Strawberry Linkus Lozenges Strawberry Front Label Linkus Lozenges Strawberry Back Label" ], "indications_and_usage": [ "Uses: Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold For temporary relief of occasional minor irritation, pain, sore mouth and sore throat" ], "set_id": "9c7a960f-89c5-4bf3-9dc0-2e49591079c5", "id": "47e38c86-dbbe-4aa1-bf0d-403f4ece2c49", "active_ingredient": [ "Menthol 5.2mg" ] }, { "effective_time": "20151216", "inactive_ingredient": [ "Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Western Family Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon Flavor Natural Honey and Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - If you are now taking a prescription monoamine oxidase (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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "9e2768ef-1ae2-470e-b338-40e6fdc1a01d", "id": "2706fa88-618e-25ff-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant." ] }, { "effective_time": "20140520", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "TopCare Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL Acetaminophen Acetaminophen DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Phenylephrine Hydrochloride Phenylephrine Acesulfame Aspartame Citric acid monohydrate Maltodextrin Sodium Citrate Sucrose Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "9e85a8ac-c0b6-4940-9408-9a551fe45a2b", "id": "24ff6c4a-adc0-4e85-837b-b84398d2b133", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20150504", "inactive_ingredient": [ "Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide." ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately." ], "purpose": [ "" ], "warnings": [ "WARNINGS Reye’s Syndrome : Children and teenagers who have or are recovering from chicken pox or 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 : Contains salicylate. Do not take if you are ■ allergic to salicylates (including aspirin) ■ taking other salicylate products Do Not Use if you have ■ bloody or black stool ■ an ulcer ■ a bleeding problem Ask a Doctor before use if you have ■ fever ■ mucus in the stool Ask a Doctor/Pharmacist before use if you are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis Stop Use and ask a doctor if ■ symptoms get worse ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. If pregnant or breast-feeding, ask a health professional before use. Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ Adults and Children 12 years and over: 525 mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hour as needed ■ do not exceed 4200 mg (16 tablets) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ Children under 12 years: ask a doctor Other information ■ save carton for full directions and warnings ■ store at room temperature 59°- 86°F (15°-30°C) ■ do not use if cellophane unit is torn ■ Phenylketonurics: contains phenylalanine 1.1 mg per tablet ■ Calcium content per tablet: 73 mg Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide." ], "when_using": [ "When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur." ], "spl_product_data_elements": [ "Bismuth Subsalicylate Bismuth Subsalicylate BISMUTH SUBSALICYLATE SALICYLIC ACID ASPARTAME CALCIUM CARBONATE D&C RED NO. 27 MAGNESIUM STEARATE AZ046" ], "ask_doctor": [ "Ask a Doctor before use if you have ■ fever ■ mucus in the stool" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ Adults and Children 12 years and over: 525 mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hour as needed ■ do not exceed 4200 mg (16 tablets) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ 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 get worse ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days" ], "do_not_use": [ "Do Not Use if you have ■ bloody or black stool ■ an ulcer ■ a bleeding problem" ], "package_label_principal_display_panel": [ "DISPLAY PANEL AZPBISMUTH12.jpg" ], "indications_and_usage": [ "USES ■ controls diarrhea ■ relives heartburn, indigestion, nausea and upset stomach without constipating" ], "set_id": "9eef79e6-3655-4b9b-93c0-b32c6e7ae0ba", "id": "4ce5c14a-4fd5-4006-9d32-338c277bc424", "ask_doctor_or_pharmacist": [ "Ask a Doctor/Pharmacist before use if you are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis" ], "active_ingredient": [ "" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Inactive ingredients aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose* * may contain" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "warnings": [ "Warnings Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet Stop using this product and ask a doctor if symptoms last more than 2 weeks Do not exceed recommended dosage. Keep out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "questions": [ "Questions or comments? Call 1-800-869-6970" ], "spl_product_data_elements": [ "Green Guard Stomach Relief calcium carbonate ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN MINERAL OIL SORBITOL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION white ROUND AZ;036" ], "ask_doctor": [ "Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 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 physician. Children under 12 years: Do not give to children under 12 years of age." ], "spl_unclassified_section": [ "Drug Facts", "Other information Phenylketonurics: contains phenylalanine 1.5 mg per tablet each tablet contains 168 mg of elemental calcium store at room temperature 59-86ºF (15-30ºC) in a dry place tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using this product and ask a doctor if symptoms last more than 2 weeks Do not exceed recommended dosage." ], "package_label_principal_display_panel": [ "101R Green Guard Stomach Relief Label Stomach relief Green Guard® Pull Out Calcium Carbonate 420 mg Carbonato de Calcio 420mg 125 Packets of 2 Tablets 250 Tablets Order #2220 Distributed by Green Guard®, St Louis, MO 63045 101R Green Guard Stomach Relief Label" ], "indications_and_usage": [ "Uses For the relief of the following symptoms associated with acid indigestion sour stomach heartburn upset stomach" ], "set_id": "a5986fb3-c5c4-489c-8e8a-9e115c9a9b0d", "id": "0cc7da33-86df-521b-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient (in each tablet) Calcium Carbonate 420 mg" ] }, { "spl_product_data_elements": [ "Diabetic Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACESULFAME POTASSIUM ASPARTAME BENZOIC ACID HYPROMELLOSE 2910 (4000 MPA.S) METHYLPARABEN PROPYLENE GLYCOL WATER ANHYDROUS CITRIC ACID strawberry flavor" ], "active_ingredient": [ "Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoonful)(TSP)) Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoonful)(TSP))" ], "purpose": [ "Purpose of Guaifenesin: Expectorant Purpose of Dextromethorphan Hydrobromide: Cough Suppressant" ], "indications_and_usage": [ "Uses ■ temporarily relieves cough due to minor throat and bronchial irritation ■ helps loosen phlegm (mucus) ■ thin bronchial secretions to make coughs more productive" ], "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 ■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema ■ cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if ■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition ■ hypersensitive to any ingredients 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." ], "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." ], "ask_doctor": [ "Ask a doctor before use if you have ■ persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema ■ cough accompanied by excessive phlegm (mucus)" ], "stop_use": [ "Stop use and ask a doctor if ■ cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition ■ hypersensitive to any ingredients" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "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." ], "dosage_and_administration": [ "Directions take every 4 hours, or as directed by a doctor, and not more than 6 doses in 24 hours. This adult product is not intended for use in children under 12 years of age. Adult and children 12 years and over 2 teaspoonfuls (TSP) Children under 12 years DO NOT USE Other information ■ store at room temperature 20°-25°C (68° - 77°F) ■ Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)" ], "dosage_and_administration_table": [ "
Adult and children 12 years and over 2 teaspoonfuls (TSP)
Children under 12 years DO NOT USE
" ], "inactive_ingredient": [ "Inactive ingredients Acesulfame-K, aspartame, benzoic acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water. May contain citric acid." ], "questions": [ "Questions 888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc 1033 Stoneleigh Ave. Carmel, NY 10512 USA" ], "package_label_principal_display_panel": [ "Container label" ], "set_id": "a8f1f959-28e1-4589-93c7-ce1878bdbd7b", "id": "ade148af-6251-4b44-922c-6a53d16d935b", "effective_time": "20140627", "version": "14", "openfda": {} }, { "effective_time": "20121002", "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 select brand ® NDC 15127-979-10 NON-DROWSY * Original Prescription Strength Allergy Relief Tablets Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine 24 Hour Allergy Relief Indoor & Outdoor Allergies No Water Needed Melts in Your Mouth Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose For Adults & Children six years & older! 10 Orally Disintegrating Tablets ٭ Compare to the active ingredient of Claritin ® RediTabs ® * When taken as directed. See Drug Facts Panel. Distributed by: SELECT BRAND ® DISTRIBUTORS 5079375/R0610 This is the 10 count blister carton label for Select Brand 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": "abeae0a6-7f41-45e3-b2ae-145a2e633bc7", "id": "a90cd258-ffa6-44e9-aaa0-04bdae94487e", "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": "20150602", "inactive_ingredient": [ "Inactive ingredients aspartame*, corn starch*, croscarmellose sodium*, D&C yellow #10*, FD&C blue #1*, magnesium stearate, mint flavor, silicon dioxide*, sorbitol*, starch*, sucrose* *may contain" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "warnings": [ "Warnings Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet Stop using this product and ask a doctor if symptoms last more than 2 weeks Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." ], "questions": [ "Questions or comments Call 1-800-634-7680" ], "spl_product_data_elements": [ "Medi First Antacid calcium carbonate ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SORBITOL CALCIUM CARBONATE CARBONATE ION CALCIUM CATION white ROUND AZ;036 MINT Medi First Plus Antacid calcium carbonate ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SORBITOL CALCIUM CARBONATE CARBONATE ION CALCIUM CATION white ROUND AZ;036 MINT Medique Alcalak calcium carbonate ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SORBITOL CALCIUM CARBONATE CARBONATE ION CALCIUM CATION white ROUND AZ;036 MINT" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 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 physician. Children under 12 years: Do not give to children under 12 years of age." ], "spl_unclassified_section": [ "Drug Facts", "Other information Phenylketonurics: contains phenylalanine 1.5 mg per tablet each tablet contains 168 mg of elemental calcium store at room temperature 59º-86º F (15º-30º C) in a dry place tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using this product and ask a doctor if symptoms last more than 2 weeks" ], "package_label_principal_display_panel": [ "Principle Display Panel - 101R MF Antacid Label 250 Tablets (125 x 2) Medi-First® Antacid Calcium Carbonate Antiacido Carbonato de Calcio Pull to Open Tire Para Abrir Calcium Rich Chewable Tablets Tabletas Masticbles, Ricas en Calcio Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias Compare active ingredient to: Compare el ingrediente activo con: Tums® Registered Trademark of Smithkline-Beecham Marca Registrada de Smithkline-Beecham Principle Display Panel - 101R MF Antacid Label", "Principle Display Panel - 101R MFP Antacid Label 100 Tablets (50 x 2's) Medi-First® Plus Antacid Calcium Carbonate Pull to Open Tire Para Abrir Calcium Rich Chewable Tablets Tabletas Masticbles, Ricas en Calcio Tamper Evident Unit Dose Packets Empaquetado con sellado evidente en dosis unitarias Compare active ingredient to: Tums® Registered Trademark of Smithkline-Beecham Principle Display Panel - 101R MFP Antacid Label", "Principle Display Panel - 101R Medique Alcalak Label Medique ® Alcalak Collect MediBucks See inside flap for more details Calcium-Rich Chewable Tablets Tabletas Masticables, Ricasen Calcio Heartburn, Indigestion • Calcium Carbonate 420 mg las agruras, la indigstion • Carbonato de Calcio 420 mg Pull to Open Tire Para Abrir Mint Flavor Sabor de la menta 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado consellado evidente en dosis unitarias 101R Medique Alcalak Label" ], "indications_and_usage": [ "Uses For the relief of the following symptoms associated with acid indigestion sour stomach heartburn upset stomach" ], "set_id": "ae037bb3-122d-4a14-92a1-08a17a5f2a1b", "id": "178c38cb-b5ab-6918-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or health professional before use if you have been taking a prescription drug. Antacids may interact with certain prescription drugs. kidney stones a calcium-restricted diet" ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium Carbonate 420 mg" ] }, { "effective_time": "20111111", "inactive_ingredient": [ "Inactive Ingredients aspartame, bittermask, citric acid, glycerin, ethyl maltol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, FD&C red #40, strawberry cream flavor, and sucrose." ], "purpose": [ "Purpose Expectorant Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not use if you are now takin g 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." ], "questions": [ "Questions? Comments? Call 1-866-934-6025" ], "spl_product_data_elements": [ "GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ASPARTAME CITRIC ACID MONOHYDRATE GLYCERIN ETHYL MALTOL METHYLPARABEN POTASSIUM CITRATE POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER FD&C RED NO. 40 SUCROSE strawberry-cream" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 12 years of age and over: 10 mL every 4 hours, not to exceed 6 doses in 24 hours. Children 6 to under 12 years of age: 5 mL every 4 hours, not to exceed 6 doses in 24 hours. Children 2 to under 6 years of age: 2.5 mL every 4 hours, not to exceed 6 doses in 24 hours. Children under 2 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 Store at 20°-25°C (68°-77°F)." ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive. Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis). Temporarily relieves nasal stuffiness. Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure." ], "set_id": "ae76bdc6-430b-44a7-8610-90366c7a4daa", "id": "b18b590d-5c2e-4309-9496-67b306af040c", "active_ingredient": [ "Active Ingredients (each 5 mL) Guaifenesin 200 mg Phenylephrine hydrochloride 5 mg" ] }, { "effective_time": "20100308", "inactive_ingredient": [ "Ascorbic Acid, Aspartame, Citric Acid, Cherry Flavor, Colorants Red No. 40, Eucalyptus Oil, Hyssop, Large leaf Geiger Tree, Lesser Galangal, Licorice, Liquid Glucose, Long Pepper, Malabar Nut, Sweet Violet" ], "purpose": [ "Cough Suppresant, Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly. These may be serious." ], "questions": [ "Questions or comments: 1-888-654-3724 Monday thru Friday, 9am-5pm or visit www.Herbion.com" ], "spl_product_data_elements": [ "Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol MENTHOL MENTHOL NONE" ], "description": [ "Other Information: store in a cool, dry place, below 25 degrees C Protect from heat and light Diabetic patients should not use linkus lozenges without the advice of physician and they should monitor glucose levels closely while taking lozenges as it may alter blood glucose levels Manufactured for: Herbion USA Inc. Williamsville NY 14221 1-888-(OK-HERBION)-654-3724 info.us@herbion.com www.herbion.com" ], "ask_doctor": [ "Ask a doctor before use if you have: A persistent or chronic cough such as occurs with smoking, asthma, emphysema A cough that is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and over Take 1-2 lozenges every 2 to 3 hours not more than 8 lozenges in 24 hours Children 6 years to under 12 years Take 1 lozenge every 5 to 6 hours not more than 4 lozenges in 24 hours Children under 6 years of age Consult your 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: Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persisted headache. These could be signs of a serious condition Sore throat symptoms do not improve in 7 days Irritation, pain or redness persists or worsens" ], "package_label_principal_display_panel": [ "Linkus Lozenges Sugar Free Cough Suppresant Oral Anesthetic Relieves Cough and Soothes Sore Throat Cherry Linkus Lozenges CherryFront Label Linkus Lozenges Cherry Back Label" ], "indications_and_usage": [ "Uses: Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold For temporary relief of occasional minor irritation, pain, sore mouth and sore throat" ], "set_id": "aeef7a65-144f-460c-a88c-7b26a84345f0", "id": "86d55ddc-81be-4418-a0b0-bc7c6286aaa7", "active_ingredient": [ "Menthol 5.2mg" ] }, { "effective_time": "20090629", "inactive_ingredient": [ "Other Ingredients: ACACIA ACESULFAME POTASSIUM ASPARTAME MANNITOL MENTHOL PHENYLALANINE TITANIUM DIOXIDE XYLITOL" ], "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 12 pieces in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor. Stop use and ask a doctor if symptoms last for more than two weeks. Keep out of reach of children" ], "when_using": [ "When using this product do not take more than 12 pieces in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor." ], "questions": [ "Questions ? Call 1-800-344-7239 or write to Consumer Affairs at address below." ], "spl_product_data_elements": [ "Chooz Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION XYLITOL MANNITOL ACACIA MENTHOL TITANIUM DIOXIDE ACESULFAME POTASSIUM ASPARTAME PHENYLALANINE" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 12 years of age and older, chew 1 piece every 2 to 4 hours, or as directed by a doctor. children under 12 years of age, consult a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749 Visit us at www.insightpharma.com" ], "stop_use": [ "Stop use and ask a doctor if symptoms last for more than two weeks." ], "storage_and_handling": [ "Other Information Each piece contains calcium 200 mg. Store at room temperature between 20°C – 25°C (68°F – 77°F)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 12 pc. Carton CHOOZ ® ANTACID/CALCIUM SUPPLEMENT CALCIUM CARBONATE Works fast to relieve acid indigestion, sour stomach, heartburn and upset stomach SAFETY SEALED: Do not use if foil imprinted with \"Chooz\" is torn or missing. Great Tasting Calcium Rich Sugar Free Formula 12 Mint Gum Pieces PRINCIPAL DISPLAY PANEL - 12 pc. Carton" ], "indications_and_usage": [ "Uses For relief of: acid indigestion heartburn sour stomach upset stomach associated with these symptoms" ], "set_id": "b2dd2047-e00b-410f-a7ee-74e9c365d4a8", "id": "c8c235bc-b50b-48ed-8379-19d1faed3d53", "active_ingredient": [ "Active Ingredient (Per Gum Piece) Calcium Carbonate 500 mg" ] }, { "effective_time": "20140417", "inactive_ingredient": [ "Inactive Ingredients Aspartame (contains phenylalanine) Beta Carotene, carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol" ], "purpose": [ "Purpose Cough Suppressant, Oral Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious." ], "when_using": [ "When using this product •do not exceed recommended dosage" ], "spl_product_data_elements": [ "Bentasil SUGAR FREE BLACKCURRANT SOFT Texture Menthol MENTHOL MENTHOL ASPARTAME BETA CAROTENE CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL PALM KERNEL OIL ACACIA MALTITOL SORBITOL XYLITOL Blackcurrant and Menthol Lozenge NONE Dark Purple" ], "ask_doctor": [ "Ask a doctor before use if you have •persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions •adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. •children under 5 years: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if •cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens" ], "spl_unclassified_section": [ "Other Information • Phenylketonurics: Contains Phenylalanine (0.9) mg per drop. • 3.7 calories per drop" ], "package_label_principal_display_panel": [ "Product Label image description" ], "indications_and_usage": [ "Uses •for the temporary relief of minor sore throat •for the temporary relief of coughs due to a cold" ], "set_id": "b4930fbe-452f-4f96-a2cd-768bc51c1f49", "id": "2356095f-b006-411f-8de0-7d4c867368c2", "active_ingredient": [ "Active Ingredient Menthol 5mg" ] }, { "effective_time": "20151204", "inactive_ingredient": [ "Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "WinCo Foods Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon Flavor Natural Honey and Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "b5466a08-755a-4d43-8e32-43cec9de9472", "id": "26195b21-eba9-6a11-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant." ] }, { "effective_time": "20120919", "inactive_ingredient": [ "Inactive ingredients aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide. DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING" ], "purpose": [ "Purpose Bulk-forming laxative" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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 the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake" ], "spl_product_data_elements": [ "Sunmark fiber Smooth Texture psyllium husk PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary adults and children 12 years and over 1 rounded teaspoon 6 to under 12 years 1/2 teaspoon under 6 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Fiber Supplement Information Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program. Warnings Read entire label, including warnings in Drug Facts Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz of liquid 3 times daily. Children under 12 years : Consult a doctor. NOTICE : Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you havbe difficulty swallowing. See choking warning." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 30 mg and sodium 5 mg Phenylketonurics: contains phenylalanine 25 mg per teaspoon store at (20 o -25 o C) 68 o -77 o F" ], "package_label_principal_display_panel": [ "PDP Sunmark Compare to the active ingredient in Metamucil ® fiber Smooth Texture Sugar Free Bulk-forming laxative and Dietary fiber supplement 100% Natural Psyllium Seed Husk Fiber Orange Flavor Naturally and Artificially Flavored net wt 10 oz (283 g) 48 teaspoon doses sugar free smooth texture" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "bbdff158-9ea9-4ee0-bdaf-c3cfbf7348d4", "id": "733836c8-642d-460f-9414-be13e1534fc2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (per each rounded teaspoon=5.8 g) psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 rounded teaspoon
6 to under 12 years 1/2 teaspoon
under 6 years ask a doctor
" ] }, { "effective_time": "20131204", "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 Do not take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "QUESTIONS? Call 1-877-932-7948" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, Ask a health professional before use." ], "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": "bc253aa7-686c-40e6-affa-a585b465046a", "id": "35af7285-9558-4f37-a826-594676f46763", "ask_doctor_or_pharmacist": [ "" ], "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 Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor" ], "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)." ], "spl_product_data_elements": [ "Loratadine Loratadine LORATADINE LORATADINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL SODIUM STEARYL FUMARATE White to Off-White flat face, beveled edged 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" ], "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 equaline ® compare to Claritin ® RediTabs ® active ingredient ** NDC 41163-528-69 original prescription strength melts in your mouth allergy relief loratadine orally disintegrating tablets, USP 10 mg antihistamine no water needed indoor and outdoor allergies non-drowsy* 24 hour relief of: runny nose itchy, watery eyes sneezing itchy throat or nose 10 orally disintegrating tablets * When taken as directed. See Drug Facts Panel. DISTRIBUTED BY SUPERVALU INC. 5105058/ R0913 equalinelabel" ] }, { "effective_time": "20150609", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg 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. Prompt 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" ], "questions": [ "Questions or Comments? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "bc32a4fa-498a-4912-a4f1-f8e5057ab6af", "id": "6e7d4f42-d756-4787-8b8a-13d40b0692a2", "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 packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 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 in a child under 4 years of age if you are allergic to acetaminophen 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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 care professional before use. Keep out of reach of children. 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": [ "Daytime Flu and Severe Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid FD&C blue No. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "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 occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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 in a child under 4 years of age if you are allergic to acetaminophen 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." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton NDC 51672-2112-7 Compare to the active ingredients in Theraflu ® Daytime Severe Cold & Cough* See New Warnings Information & Directions Daytime Flu & Severe Cold & Cough Acetaminophen - Pain reliever/fever reducer Dextromethorphan HBr - Cough suppressant Phenylephrine HCl - Nasal decongestant Nasal & Sinus Congestion Sore Throat Pain Cough Headache Body Ache Fever Berry Infused with Menthol & Green Tea Flavors 6 Packets Principal Display Panel - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20151216", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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." ], "spl_product_data_elements": [ "Best Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "c687a990-a306-494b-9193-115987ff4679", "id": "270a6b5f-39d8-0bf5-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "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." ], "active_ingredient": [ "Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20150504", "inactive_ingredient": [ "Inactive ingredients aspartame, croscarmellose sodium, D&C red #7, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose." ], "purpose": [ "PURPOSE Analgesic/Antipyretic" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning : This product contains acetaminophen. Severe liver damage may occur if ■ your child takes more than 5 doses in 24 hours ■ taken 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 Ask a Doctor before use if your child has liver disease Ask a Doctor/Pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050 Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems" ], "spl_product_data_elements": [ "Children Acetaminophen Grape Flavored Chewable Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ASPARTAME CROSCARMELLOSE SODIUM D&C RED NO. 7 MANNITOL FD&C BLUE NO. 1 AZ023" ], "ask_doctor": [ "Ask a Doctor before use if your child has liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS ■ this product does not contain directions or complete warnings for adult use ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age. Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 Age (yrs) Under 2 2-3 4-5 6-8 9-10 11 Tablets Consult a doctor 2 3 4 5 6 Other information ■ Phenylketonurics: contains phenylalanine 2.8 mg per tablet ■ store at room temperature ■ protect from excessive moisture ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients aspartame, croscarmellose sodium, D&C red #7, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose." ], "stop_use": [ "Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050" ], "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" ], "package_label_principal_display_panel": [ "DISPLAY PANEL picture of carton" ], "indications_and_usage": [ "USES Temporary relief of minor aches and pains associated with ■ common cold and flu ■ headache ■ toothache ■ sore throat ■ immunizations ■ and reduction of fever" ], "set_id": "ca3d0d80-7d7e-478d-b0c2-ecc9bdb1dd1e", "id": "90120c6b-e5da-48c8-8c0d-8edf43cb90a1", "ask_doctor_or_pharmacist": [ "Ask a Doctor/Pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95
Age (yrs) Under 2 2-3 4-5 6-8 9-10 11
Tablets Consult a doctor 2 3 4 5 6
" ] }, { "effective_time": "20130705", "inactive_ingredient": [ "Nighttime Inactive Ingredient Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.", "Daytime Inactive Ingredient Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Purpose Nighttime Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever.", "Purpose Daytime Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Keep out of reach of children. 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." ], "warnings": [ "Nighttime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Daytime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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": [ "CVS Pharmacy Daytime Nighttime Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr CVS Pharmacy Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE Natural Honey and Lemon flavor Natural Honey and Lemon flavor Caramel color D and C Yellow 10 CVS Pharmacy Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE Berry infused with menthol and green tea flavors Menthol FD and C Red No 40 FD and C Blue No 1" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "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, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Nighttime Dosage & Administration Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.", "Daytime Dosage & Administration Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "do_not_use": [ "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - 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 a 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 - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "information_for_patients": [ "Nighttime Information for Patients Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.", "Daytime Information for Patients Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "carton.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "set_id": "ce1b51d0-25b3-43d9-924d-293b3b5eaeb2", "id": "41524cba-b79a-4f94-81e5-0ad3bb843918", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. 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." ], "overdosage": [ "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.", "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." ], "active_ingredient": [ "Active Ingredients for Nighttime Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.", "Active Ingredients for Daytime Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20100623", "inactive_ingredient": [ "Inactive ingredients aspartame, carboxymethylcellulose sodium, citric acid, flavor, high fructose corn syrup, honey flavor, menthol flavor, polyethylene oxide, polysorbate 60, potassium acesulfame, propylene glycol, purified water, sodium benzoate, sodium citrate" ], "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 a sodium restricted diet 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 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." ], "questions": [ "Questions? 1-800-344-7490" ], "spl_product_data_elements": [ "Vicks Casero Chest Congestion Relief Guaifenesin Guaifenesin Guaifenesin" ], "ask_doctor": [ "Ask a doctor before use if you have a sodium restricted diet persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well before using use dose cup (12.5 ml = 2½ tsp) do not exceed 6 doses per 24 hours adults and children 12 years and over 12.5 ml every 4 hours children 6 to under 12 years 6.25 ml every 4 hours children 4 to under 6 years 3.12 ml every 4 hours children under 4 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distr. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each 12.5 ml dose contains sodium 32 mg phenylketonurics: contains phenylalanine 5.5 mg per adult dose store at room temperature keep dose cup for accurate dosing" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 240 ml Bottle Label VICKS ® Casero ® CHEST CONGESTION RELIEF Guaifenesin...Expectorant Honey / Menthol 8 FL OZ (240 ml) See Drug Facts Principal Display Panel - 240 ml Bottle Label" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus" ], "set_id": "ceb8d0a8-6c08-4ee7-9e39-b3699410ca5f", "id": "43d7484f-3909-4f77-8bdc-c1d2367439fc", "active_ingredient": [ "Active ingredient (in each 6.25 ml dose) Guaifenesin 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 12.5 ml every 4 hours
children 6 to under 12 years 6.25 ml every 4 hours
children 4 to under 6 years 3.12 ml every 4 hours
children under 4 years do not use
" ] }, { "effective_time": "20140112", "inactive_ingredient": [ "Inactive Ingredients aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor" ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Other Information phenylketonurics: each tablet contains: phenylalanine 0.28mg 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 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 IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Rugby® Duluth, Georgia 30097 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880" ], "spl_product_data_elements": [ "Meclizine HCl Meclizine HCl MECLIZINE HYDROCHLORIDE MECLIZINE CROSCARMELLOSE SODIUM ASPARTAME MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SUCROSE DEXTROSE FD&C RED NO. 40 RASPBERRY AP;115" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: 1-2 tablets once daily children under 12 years: ask a doctor" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Meclizine HCl COMPARE TO ACTIVE INGREDIENT IN BONINE Meclizine HCl 25 mg (ANTIEMETIC) NDC 33261-0413-30 30 CHEWABLE TABLETS Contains Aspartame Rugby Duluth, Georgia 30097 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 IMAGE LABEL" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting, or dizziness due to motion sickness" ], "set_id": "cf1332f0-8662-45ed-a76f-3e620f60f05b", "id": "433935fb-4377-4c68-9fd8-b127bf281095", "active_ingredient": [ "Active Ingredient (in each tablet) Meclizine HCl 25 mg" ] }, { "effective_time": "20130403", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive ingredients: Magnesium hydroxide, L-menthol, Aspartame, Sugar, Povidone, Lactose Hydrate, Spirulina color, Mint flavor, Calcium carboxymethylcellulose, Magnesium stearate" ], "purpose": [ "PURPOSE Effective for: Relieves:Heartburn, Sour stomach, Acid indigestion, Upset stomach associated with these symptoms" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS 1. The following people must consult a doctor, dentist or pharmacist before administering the drug. (1) Patients with kidney disorders (2) Patients taking other drugs 2. Patients must immediately stop adminstration of the drug and consult a doctor, dentist or pharmacist if the following symptoms are observed. Carry these instructions when visiting. (1) If symptoms of constipation or diarrhea occur while administering this drug (2) When no improvement is detected after 2 weeks of administration 3. Other precautions when administering this drug (1) Follow the given instructions and dosages (2) When administering to children, it must be administered under the supervision of a parent or guardian 4. Storage directions (1) Store in places out of the reach of children (2) Keep away from direct sunlight and store sealed in cool places with low humidity. (3) Do not store in different containers in order to prevent misuse and preserve quality (Only store in container if it has been specifically labelled and is not open to misuse)" ], "spl_product_data_elements": [ "HIS ULC MINT BLUE Calcium carbonate Calcium carbonate CALCIUM CATION magnesium hydroxide Aspartame SSPN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime Taking a melt in your mouth and chew." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime Taking a melt in your mouth and chew." ], "set_id": "d2b9e29f-7cc8-470b-9546-9614f8eda199", "id": "b1cce823-c1c1-4653-8047-fbc087977c58", "active_ingredient": [ "ACTIVE INGREDIENT Active ingredient: Calcium carbonate 350mg" ] }, { "effective_time": "20140122", "inactive_ingredient": [ "Inactive ingredients aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide. DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING" ], "purpose": [ "Purpose Bulk-forming laxative" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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 the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. 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": [ "Guardian psyllium husk PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary adults and children 12 years and over 1 rounded teaspoon 6 to under 12 years 1/2 teaspoon under 6 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Fiber Supplement Information Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program. Warnings Read entire label, including warnings in Drug Facts Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz of liquid 3 times daily. Children under 12 years : Consult a doctor. NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you havbe difficulty swallowing. See choking warning." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 30 mg and sodium 5 mg Phenylketonurics : contains phenylalanine 25 mg per teaspoon store at (20 o -25 o C) 68 o -77 o F" ], "package_label_principal_display_panel": [ "PDP Guardian Compare to the active ingredient in Metamucil ® Sugar Free Natural Fiber Orange Flavor Psyllium Husk Bulk-forming laxative Fiber Laxative Dietary Supplement Relieves Constipation Restores Regularity 114 TEASPOON DOSES Net wt 23.3oz 1.4 LBS (660 g) GDC405 MM1" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "d7655c03-8a47-4349-940c-f51c876ebeef", "id": "1787aec2-b365-4d67-80a6-fc0fe1f781d1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "active_ingredient": [ "Active ingredient (per each rounded teaspoon=5.8 g) psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 rounded teaspoon
6 to under 12 years 1/2 teaspoon
under 6 years ask a doctor
" ] } ] }