{ "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": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 1100 } }, "results": [ { "effective_time": "20130501", "inactive_ingredient": [ "Inactive ingredients benzoic acid , carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, flavors, glycerides (C14-18, mono- and di-), maltitol, methylcellulose, microcrystalline cellulose, polyoxyl 40 stearate, polysorbate 65, purified water, silica gel, sodium benzoate, sodium citrate, xanthan gum" ], "purpose": [ "Purpose Antigas" ], "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 Keep out of reach of children . In case of overdose get medical help or contact a poison control center right away. (1-800-222-1222)" ], "questions": [ "Questions or comments? Call 1-800-222-9435 (English) or 1-888-466-8746 (Spanish)" ], "spl_product_data_elements": [ "Infants MYLICON Simethicone Dimethicone Dimethicone benzoic acid carboxymethylcellulose sodium anhydrous citric acid D&C Red NO. 22 D&C Red NO. 28 maltitol cellulose, microcrystalline polyoxyl 40 stearate water sodium benzoate sodium citrate xanthan gum" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions shake well before using all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids clean dropper well after each use – recap bottle with original cap Age (yr) Weight (lb) Dose Infants under 2 Under 24 0.3 mL Children over 2 Over 24 0.6 mL" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information do not use if printed plastic overwrap or printed neck wrap is missing or broken Store between 20 - 25°C (68 - 77°F do not freeze see bottom panel for lot number and expiration date" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 16837-630-15 Infants' MYLICON ® Simethicone-Antigas Gas Relief Gently breaks down baby's gas bubbles ORIGINAL DROPS #1 BRAND RECOMMENDED BY PEDIATRICIANS & USED BY MOMS Safe enough to use at every feeding* 1/2 FL OZ (15mL) *use as directed Principal Display Panel" ], "indications_and_usage": [ "Uses Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods." ], "set_id": "00738f01-8010-49bd-a903-568d1b134ac0", "id": "86a8ceb6-ca78-438e-8112-ac2e95b24301", "active_ingredient": [ "Active ingredients (in each 0.3mL) Simethicone 20 mg" ], "dosage_and_administration_table": [ "
Age (yr) Weight (lb) Dose
Infants under 2 Under 24 0.3 mL
Children over 2 Over 24 0.6 mL
" ] }, { "effective_time": "20120503", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product: Do not use more than directed." ], "questions": [ "Questions? 877-434-2036" ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing." ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache Temporarily reduces fever" ], "set_id": "00ab90e8-7824-411f-bf4d-a540c2a8a4c3", "id": "3614e44e-8510-4fd2-9762-741b9659323d", "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 5 mL = 1 teaspoon) Acetaminophen 160 mg" ], "dosage_and_administration_table": [ "
Age (yr) Dose (mL or tsp)
tsp. = teaspoon
mL = milliliter
under 6 mos. ask a doctor
6 mos. to under 2 2.5 mL or ½ tsp.
2 to under 4 5 mL or 1 tsp.
4 to under 6 7.5 mL or 1½ tsp.
6 to under 9 10 mL or 2 tsp.
9 to under 11 12.5 mL or 2½ tsp.
11 to under 12 15 mL or 3 tsp.
or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum" ], "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 drug containing acetaminophen (prescription or nonprescription). 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 before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product: Do not use more than directed. 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). Prompt medical attention is critical, even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen Acetaminophen Acetaminophen Citric Acid Monohydrate Corn Syrup FD&C red no. 40 D&C red no. 33 Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium benzoate Sucralose Sorbitol Xanthan Gum" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions This product does not contain directions or complete warnings for adult use. shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose. when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) tsp. = teaspoon mL = milliliter under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC. Palm Beach Gardens, FL 33408" ], "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." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist If your child is allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton Children's ACCUDIAL ® Acetaminophen Oral Suspension Pain Reliever / Fever Reducer For ages 6 mos. to under 12 yrs. or 12-95 lbs. Alcohol Free • Aspirin Free • Ibuprofen Free Compares to the active ingredient in Children's Tylenol ® Oral Suspension. ROTATING LABEL FOR WEIGHT-BASED DOSING Bubblegum Flavor 4 FL.OZ. (120 mL) 80 mg per 1/2 teaspoon (160 mg per 5 mL) NDC 45014-137-04 Principal Display Panel - 120 mL Bottle Carton" ] }, { "effective_time": "20130328", "inactive_ingredient": [ "Inactive ingredients Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose" ], "purpose": [ "Purpose Anti-gas" ], "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 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": [ "Infants Gas Relief Original Formula Dimethicone Dimethicone Dimethicone Sodium Benzoate Citric Acid Monohydrate Hypromelloses Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) Sucralose Vanillin Sodium Citrate Water FD&C Red No. 3 Opaque" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well before using all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids for best results, clean dropper after each use and replace original cap Age (yr) Weight (lb) Dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895" ], "storage_and_handling": [ "Other information do not use if printed foil seal under cap is torn or missing store at room temperature do not freeze see bottom panel for lot number and expiration date" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton CVS pharmacy ® Compare to the active ingredient in Infants' MYLICON ® Drops* Infants' GAS RELIEF ORIGINAL FORMULA SIMETHICONE/ANTIGAS No alcohol No saccharin No artificial flavor 100 Doses 1 FL OZ (30 mL) PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton" ], "indications_and_usage": [ "Uses Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods." ], "set_id": "010e5c7e-1c2c-49ab-a9ca-6e89ae86a6d3", "id": "515304f7-b849-4c1a-8384-ad48f9199777", "active_ingredient": [ "Active ingredient (in each 0.3 mL) Simethicone 20 mg" ], "dosage_and_administration_table": [ "
Age (yr) Weight (lb) Dose
infants under 2 under 24 0.3 mL
children over 2 over 24 0.6 mL
" ] }, { "effective_time": "20121220", "inactive_ingredient": [ "Inactive ingredients Aqua (Water) , C12-15 alkyl benzoate, Octocrylene, Glycerin, Alcohol denat., Dimethicone, Cetearyl olivate, Tribehenin, Methyl methacrylate cross-polymer, Butyrospermum parkii (Shea) butter, Cetearyl alcohol, Sorbitan olivate, Sodium polyacrylate, Salix nigra (Willow) bark extract, Prunus amygdalus dulcis (Sweet almond) oil, Phenoxyethanol, Dimethicone crosspolymer, Caprylyl glycol, Xanthan gum, Citric acid, Dipropylene glycol, Sodium benzoate, Geraniol, Ethylhexylglycerin, Limonene, Tetrasodium EDTA, Linalool, Tocopheryl acetate, Citrus limon (Lemon) peel oil, Juniperus mexicana oil, Citral, Salvia sclarea (Clary) oil, Methyl hydrogenated rosin, Triethyl citrate, Parfum (Fragrance), Artemisia herba-alba oil" ], "purpose": [ "Uses Uses - helps prevent sunburn." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away." ], "spl_product_data_elements": [ "Botanics Mattifying Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER C12-15 ALKYL BENZOATE GLYCERIN DIMETHICONE CETEARYL OLIVATE TRIBEHENIN SHEA BUTTER CETOSTEARYL ALCOHOL SORBITAN OLIVATE SODIUM POLYACRYLATE (8000 MW) SALIX NIGRA BARK ALMOND OIL PHENOXYETHANOL CAPRYLYL GLYCOL XANTHAN GUM CITRIC ACID MONOHYDRATE DIPROPYLENE GLYCOL SODIUM BENZOATE ETHYLHEXYLGLYCERIN EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE JUNIPERUS DEPPEANA WOOD OIL CLARY SAGE OIL TRIETHYL CITRATE" ], "description": [ "Description This lightweight formula absorbs quickly without greasiness to provide balanced hydration and lasting protection from shine. Visibly tightens pores. Non comedogenic. Active plant extract, Willowbark is a natural source of salicylic acid which helps refine skin texture and actively target imperfections. Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.", "Description Directions: Use every morning after cleansing" ], "warnings_and_cautions": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove", "Warnings Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately." ], "ask_doctor": [ "Ask a doctor Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "2", "storage_and_handling": [ "Storage Other information - protect the product in this container from excessive heat and direct sun" ], "information_for_patients": [ "Information Made in the UK. The Boots Company PLC Nottingham England NG2 3AA Dist. in the USA by Boots Retain USA Inc. Norwalk CT 06851 USA www.boots.com", "Information The Boots Company PLC Notingham England NG2 3AA Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA Made in the UK www.boots.com" ], "package_label_principal_display_panel": [ "Carton Carton label Carton" ], "indications_and_usage": [ "Directions Directions for sunscreen use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "set_id": "013e5a63-2074-44b6-aef4-acc954177c7f", "id": "edb33106-2fa3-4db8-afd1-f8e3ae50606c", "active_ingredient": [ "Carton Active Ingredients Section Active Ingredients Avobenzone 3% Octisalate 3% Octocrylene 5% Purpose Sunscreen", "Jar label Boots Botanics The Power of Plants Mattifying Day Cream Sunscreen Broad Spectrum SPF 15 50ml e 1.69 US Fl. Oz. Active ingredients: Avobenzone 3%, Octisalate 3%, Octocrylene 5%" ] }, { "effective_time": "20121203", "inactive_ingredient": [ "Inactive Ingredients: Alcohol, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, C13-14 Isoparaffin, Cyclomethicone, Glyceryl Stearate, Laureth-7, PEG-100 Stearate, Polyacrylamide, Citrullus Lanatus (Watermelon) Fruit Extract, Steareth-21, Synthetic Beeswax, Dimethicone, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Lentinus Edodes (Shiitake Mushroom) Extract, Macrocystis Pyrifera (Kelp) Extract, Pisum Sativum (Pea) Extract, Caprylyl Glycol, Castor Oil Phosphate, Sodium Benzoate, Potassium Sorbate, Annatto, Dipotassium Glycyrrhizinate, Disodium EDTA, Ferulic Acid, Maltodextrin, Phyllanthus Emblica Fruit Extract, Sodium Hyaluronate, Tetrahydro Curcuminoids, Sorbic Acid, Tetrahexyldecyl Ascorbate, Phospholipids, Retinyl Palmitate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol, Sodium Dehydroacetate, Phenoxyethanol, water." ], "purpose": [ "Purpose: Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings: For external use only Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Ingenue Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF ALKYL (C12-15) BENZOATE GLYCERIN C13-14 ISOPARAFFIN CYCLOMETHICONE GLYCERYL MONOSTEARATE LAURETH-7 PEG-100 STEARATE POLYACRYLAMIDE (10000 MW) WATERMELON STEARETH-21 SYNTHETIC WAX (1800 MW) DIMETHICONE OLIVE OIL SUNFLOWER OIL GREEN TEA LEAF CHAMOMILE CUCUMBER CARROT GLYCYRRHIZA GLABRA LENTINULA EDODES MYCELIUM MACROCYSTIS PYRIFERA PEA CAPRYLYL GLYCOL CASTOR OIL SODIUM BENZOATE POTASSIUM SORBATE ANNATTO GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM FERULIC ACID MALTODEXTRIN PHYLLANTHUS EMBLICA FRUIT HYALURONATE SODIUM TETRAHYDRODIFERULOYLMETHANE SORBIC ACID TETRAHEXYLDECYL ASCORBATE ASCORBYL PALMITATE TOCOPHEROL SODIUM DEHYDROACETATE PHENOXYETHANOL WATER ALCOHOL CYCLOMETHICONE 5 CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN SOYBEAN EGG PHOSPHOLIPIDS TRIETHOXYCAPRYLYLSILANE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: ask a doctor Sun protection measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses." ], "package_label_principal_display_panel": [ "image" ], "indications_and_usage": [ "Uses: Helps prevent sunburn" ], "set_id": "018c7150-ac31-4376-a769-d35ea7456bcd", "id": "78c157ec-598d-4916-9cf2-7e9619f26ca0", "active_ingredient": [ "Active Ingredient: Zinc Oxide 14.5%" ] }, { "effective_time": "20110526", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Citric acid, Demineralized water, Glycerin, Sodium benzoate." ], "purpose": [ "INDICATIONS: For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle." ], "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: 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. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place." ], "questions": [ "Distributed by: BIOACTIVE NUTRITIONAL Melbourne, FL 32935 For Nutritional Information write: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935" ], "spl_product_data_elements": [ "Melatonin Forte Niacin, Melatonin, Nadidum, Pyridoxinum hydrochloricum, Zincum sulphuricum, Hypothalamus, Lithium carbonicum, Magnesia carbonica, Pineal, Pituitary, NIACIN NIACIN MELATONIN MELATONIN NADIDE NADIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE ZINC SULFATE HEPTAHYDRATE ZINC CATION SUS SCROFA HYPOTHALAMUS SUS SCROFA HYPOTHALAMUS LITHIUM CARBONATE LITHIUM CATION MAGNESIUM CARBONATE MAGNESIUM CATION SUS SCROFA PINEAL GLAND SUS SCROFA PINEAL GLAND SUS SCROFA PITUITARY GLAND SUS SCROFA PITUITARY GLAND GLYCERIN SODIUM BENZOATE CITRIC ACID MONOHYDRATE WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS: Three sprays per day. Hold in mouth for two minutes. Consult a physician for use in children under 12 years of age." ], "package_label_principal_display_panel": [ "BioActive Homeopathic MELATONIN FORTE 1 FL OZ (30 ML) Melatonin Forte" ], "indications_and_usage": [ "INDICATIONS: For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle." ], "set_id": "019075cf-3fd1-487d-87c0-9a51310f6015", "id": "ceb09115-7968-4595-bc80-787707e656a2", "active_ingredient": [ "ACTIVE INGREDIENTS: Niacin 3X, Melatonin 6X, Nadidum 6X, Pyridoxinum hydrochloricum 6X, Zincum sulphuricum 6X, Hypothalamus 8X, Lithium carbonicum 89X, Magnesia carbonica 8X, Pineal 8X, Pituitary 8X." ] }, { "effective_time": "20140506", "inactive_ingredient": [ "Other ingredients water, decyl glucoside, lauryl glucoside, pyroligeneous acid purified (USP), glycerine (USP), xanthan gum, potassium sorbate, sodium benzoate" ], "purpose": [ "NON-TOXIC Professional Formula X-PEL PURE Anti-Lice Shampoo & Conditioner Eliminates Lice Works in Just 10 Minutes Stops Itching Eases Egg Removal Leaves Hair Soft, Shiny & Tangle-Free Repels Lice Pediatrician and Dermatologist Approved 6 fl. oz. (177 mL)" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only. Avoid contact with eyes. If eye contact occurs, rinse with clear water. Keep out of reach of children. Safe for ragweed sufferers." ], "spl_product_data_elements": [ "X-PEL PURE Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre APIS MELLIFERA APIS MELLIFERA PHENOL PHENOL LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG WATER DECYL GLUCOSIDE PYROLIGNEOUS ACID LAURYL GLUCOSIDE GLYCERIN XANTHAN GUM POTASSIUM SORBATE SODIUM BENZOATE" ], "other_safety_information": [ "Cruelty Free Testing Environmentally Safe Homeopathic Formula Distributed By: Dermedics Laboratories 3900 Park Avenue, Suite 8-S, Bridgeport, CT 06604" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions SHAKE WELL BEFORE USE 1. Wet hair with warm water. 2. Apply X-PEL™ liberally and massage into wet hair until a thick lather forms. 3. Leave lather on hair for 10 minutes. Do not rinse. 4. Divide hair into sections and comb with the NitPro-II™ comb to remove lice and eggs. Rinse comb after each stroke. For instructions on how to use the comb read the insert inside the box. 5. Rinse hair with warm water. Repeat steps 2-4. 6. Finally, rinse the hair with warm water, towel dry and inspect for and comb out any remaining eggs. Clean comb with hot water and store for future use." ], "package_label_principal_display_panel": [ "label image" ], "indications_and_usage": [ "Indications For treatment of pediculosis. Eliminates Lice Makes eggs easy to remove Stops itching caused by lice bites" ], "set_id": "01b92e9e-2b1f-41f7-8188-4b15e81aade8", "id": "96a3db88-ce84-4a4b-b3d5-9151e7c16ca7", "active_ingredient": [ "Active Ingredients Apis Mellifica 15x Carbolicum Acidum 15x Ledum Palustre 15x" ] }, { "effective_time": "20140612", "inactive_ingredient": [ "Inactive ingredients Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate." ], "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" ], "spl_product_data_elements": [ "Broncomar SF Guaifenesin GUAIFENESIN GUAIFENESIN CAULOPHYLLUM THALICTROIDES ROOT ANHYDROUS CITRIC ACID ECHINACEA, UNSPECIFIED EUCALYPTUS CAMALDULENSIS LEAF OIL GINKGO BILOBA WHOLE GOLDENSEAL HOREHOUND LICORICE MENTHOL MULLEIN LEAF MYRRH POTASSIUM SORBATE ULMUS RUBRA BARK SODIUM BENZOATE PROPYLENE GLYCOL WATER SODIUM CHLORIDE SUCRALOSE PRUNUS SEROTINA BARK ZINC SULFATE GLYCERIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not take more than 6 doses in any 24-hour period Shake well before use Age Dose Adults and children 12 years and over 10 mL (2 tsps) every 4 hours Children 6 to under 12 years of age. 5 mL (1 tsps) every 4 hours Children under 6 years of age Do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask the doctor if Nervoisness, dizziness or sleeplessness occurs. Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition" ], "do_not_use": [ "Do not use if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor Ask the 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" ], "package_label_principal_display_panel": [ "BroncomarSF" ], "indications_and_usage": [ "Uses Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive." ], "set_id": "01bae271-502b-4345-b114-0072c39b4dba", "id": "1f890f7c-0ae0-4746-ad5e-de73ba503801", "active_ingredient": [ "Acvtive ingredients: (in each 5ml) Purpose Guaifenesin 100 mg ................................... Expectorant" ] }, { "effective_time": "20130913", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-289-8343" ], "spl_product_data_elements": [ "HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE D&C YELLOW NO. 10 FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE, GINGIVITIS." ], "set_id": "022f3b76-997a-43c1-b116-52f75bf92a00", "id": "ce7e359e-f064-4874-a5a2-b9782f4b384e", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20130605", "inactive_ingredient": [ "Inactive ingredients alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution" ], "purpose": [ "Purpose Cough suppressant 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" ], "when_using": [ "When using this product constipation may occur or be aggravated" ], "spl_product_data_elements": [ "Cheratussin AC codeine phosphate and guaifenesin CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN ALCOHOL CARAMEL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years consult a doctor children under 2 years do not use Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 11/09 R6 8081202 1075" ], "storage_and_handling": [ "Other information store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 ." ], "do_not_use": [ "Do not use in a child under 2 years of age if you or your child has a chronic pulmonary disease or shortness of breath if your child is taking other drugs, unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-3146-0 Relabeled by: A-S Medication Solutions Libertyville, IL 60048 3146-0.jpg" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive calms the cough control center and relieves coughing" ], "set_id": "0232c4cd-379d-4cf9-ad61-ec3cadaab132", "id": "ec13b5cb-c30f-4a40-b095-fae58eb90fb1", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 tsp) Codeine phosphate, USP 10 mg Guaifenesin, USP 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 10 mL (2 tsp)
children 6 years to under 12 years take 5 mL (1 tsp)
children 2 years to under 6 years consult a doctor
children under 2 years do not use
" ] }, { "effective_time": "20150519", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: WATER, CYCLOPENTASILOXANE, GLYCERIN,ETHYLHEXYL PALMITATE,CYCLOHEXASILOXANE,4-METHYLBENZYLIDENE CAMPHOR,NIACINAMIDE,NEOPENTYL GLYCOL DIHEPTANOATE,BUTYLENE GLYCOL, SILICA,CETEARYL ALCOHOL,GLYCERYL STEARATE,PEG-100 STEARATE,TRICETEARETH-4 PHOSPHATE,GLYCOL STEARATE,SORBITAN SESQUIOLEATE,POTASSIUM CETYL PHOSPHATE,PEG-2 STEARATE,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,FRAGRANCE(PARFUM),TROMETHAMINE,GLYCERYL CAPRYLATE,PHENOXYETHANOL,CAPRYLYL GLYCOL,DIMETHICONE,ADENOSINE,XANTHAN GUM,IRON OXIDES (CI 77492),DISODIUM EDTA,CALENDULA OFFICINALIS FLOWER EXTRACT,IRON OXIDES (CI 77491),ANTHEMIS NOBILIS FLOWER WATER,SODIUM BENZOATE,CITRIC ACID,POTASSIUM SORBATE" ], "purpose": [ "PURPOSE Purpose: Sunscreen [UV Protection]" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "CAUTIONS CAUTIONS: 1. For external use only. 2. Discontinue use if signs of irritation or rashes appear. 3. Keep out of reach of children 4. Replace the cap after use." ], "spl_product_data_elements": [ "PROVENCE CALENDULA DAILY SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER" ], "description": [ "HOW TO USE HOW TO USE: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays." ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "set_id": "023dfed8-9787-459d-90dd-1c6b0c6d6d18", "id": "be783590-147c-4f5b-a242-d88c33f08679", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 7.50%, TITANIUM DIOXIDE (CI 77891) 5.95%, BUTYL METHOXYDIBENZOYLMETHANE 2.50%, ETHYLHEXYL SALICYLATE 2.00%, OCTOCRYLENE 2.00%" ] }, { "effective_time": "20120213", "inactive_ingredient": [ "Inactive ingredients citric acid, fragrance, glycol stearate, hydroxyethylcellulose, lanolin alcohol, lauramide DEA, mineral oil, PEG-80 hydrogenated glyceryl palmate, petrolatum, sodium benzoate, sodium hydroxide, sulfonate 200, water." ], "purpose": [ "Purpose Surgical Hand Scrub" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only. Do not use if redness or irritation occurs. When using this product avoid contact with eyes. Stop use and ask a doctor if severe adverse reactions occur. Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product avoid contact with eyes." ], "questions": [ "Questions? 1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. M5T" ], "spl_product_data_elements": [ "BD E-Z Scrub Choroxylenol Chloroxylenol Chloroxylenol citric acid monohydrate glycol stearate hydroxyethyl cellulose (2000 MPA.S at 1%) lanolin alcohols lauric diethanolamide mineral oil hydrogenated palm glycerides petrolatum sodium benzoate sodium hydroxide entsufon sodium water" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Clean under nails with nail pick Wet hands and forearms Scrub thoroughly for 3 minutes paying particular attention to the nails, cuticles and interdigital spaces Rinse thoroughly Repeat scrub for 3 more minutes Rinse thoroughly" ], "spl_unclassified_section": [ "Drug Facts", "Other information avoid excessive heat 40°C (104°F) discard after single use." ], "stop_use": [ "Stop use and ask a doctor if severe adverse reactions occur." ], "do_not_use": [ "Do not use if redness or irritation occurs." ], "package_label_principal_display_panel": [ "Principal Display Panel – Box Label BD BD E-Z Scrub ™ 408 Surgical Scrub Brush/Sponge With 3% Chloroxylenol, Emollients and Nail Cleaner Ultradex ™ CONTAINS: 30 NOTE: SEE BACK PANEL FOR EASY INSTRUCTIONS Remove to check level of contents Reorder When Brushes Reach This Level. REF 374081 NDC 17271-408-10 REMOVE FOR CONVENIENT DISPENSING OF PRODUCT SEE REVERSE SIDE FOR EASY MOUNTING INSTRUCTIONS Principal Display Panel – Box Label" ], "indications_and_usage": [ "Use preoperative cleaning of healthcare personnel arms and hands. Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery." ], "set_id": "02431db6-a501-4608-938a-4b35323cc96e", "id": "eb35a5d9-ba77-4ddb-8099-5f7a4b9c5f54", "active_ingredient": [ "Active ingredient 3% (525mg) Chloroxylenol (PCMX) w/w" ] }, { "effective_time": "20111111", "inactive_ingredient": [ "inactive ingredient: silicon dioxide, triclosan, glycerin, d-sorbitol, polyethylene glycol, chitosan oligosaccharide, carboxymethylcellulose sodium, propolis extract, xylitol, sacccharin sodium hydroate, peppermint oil, l-menthol, sodium benzoate, ascorbic acid, tocopherol, purified water" ], "purpose": [ "■ prevention of gingival disease" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "if irritation occurs when using this product, discontinue use" ], "spl_product_data_elements": [ "NBF Gingival SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SILICON DIOXIDE TRICLOSAN GLYCERIN SORBITOL CHITOSAN OLIGOSACCHARIDE CARBOXYMETHYLCELLULOSE SODIUM PROPOLIS WAX XYLITOL SACCHARIN SODIUM MENTHA PIPERITA MENTHOL SODIUM BENZOATE ASCORBIC ACID TOCOPHEROL WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "■ apply three times a day after meals" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "apply toothpast on soft bristle toothbrush and brush" ], "set_id": "028fbb3a-87f4-4f82-88e5-346f5a17753c", "id": "c9d5436a-b2fe-4e0f-aaa9-4a584fbd59e9", "active_ingredient": [ "active ingredient: sodium monofluorophosphate" ] }, { "effective_time": "20120604", "inactive_ingredient": [ "Inactive Ingredients: Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, dimethicone, cetyl alcohol, cocamide MEA, sodium chloride, fragrance, guar hydroxypropyltrimonium chloride, hydrogenated polydecene, sodium citrate, sodium benzoate, polyquaternium 10, PEG-7M, trimethylolpropane tricaprylate/tricaprate, citric acid, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, ammonium xylene sulfonate, Yellow 10, Blue 1." ], "purpose": [ "Purpose: Anti-Dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warning: For external use only" ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions or Comments? 1-800-487-7273 www.pertplus.com Idelle Labs, Ltd. All rights reserved Made in Canada. Distributed by Idelle Labs, Ltd., El Paso, TX 79912" ], "spl_product_data_elements": [ "Pert Plus 2 in 1 Shampoo and Conditioner Anti-Dandruff Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC WATER AMMONIUM LAURETH-5 SULFATE AMMONIUM LAURYL SULFATE GLYCOL DISTEARATE DIMETHICONE CETYL ALCOHOL COCO MONOETHANOLAMIDE SODIUM CHLORIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) HYDROGENATED POLYDECENE (550 MW) SODIUM CITRATE SODIUM BENZOATE POLYQUATERNIUM-10 (400 CPS AT 2%) POLYETHYLENE GLYCOL 7000 TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE CITRIC ACID MONOHYDRATE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE AMMONIUM XYLENESULFONATE FD&C BLUE NO. 1 D&C YELLOW NO. 10" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: For best results, use at least twice a week or as directed by a doctor. Gently massage into wet hair, lather and rinse. Repeat if desired." ], "spl_unclassified_section": [ "Pert Plus 2 in 1 Shampoo and Conditioner Anti-Dandruff for flake-free hair Great hair should be simple Use daily: 1. Wet 2. Lather 3. Rinse. MM1" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "label principal display panel" ], "indications_and_usage": [ "Uses Controls the symptoms of dandruff." ], "set_id": "02b5ae60-97b4-4c00-8fc9-ea5181a6f15d", "id": "02b5ae60-97b4-4c00-8fc9-ea5181a6f15d", "active_ingredient": [ "Active Ingredient Active Ingredient Pyrithione Zinc 1.0%" ] }, { "effective_time": "20150122", "inactive_ingredient": [ "purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext" ], "purpose": [ "for dental care" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "do not swallow" ], "spl_product_data_elements": [ "The Gargle SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION ALLANTOIN XYLITOL CITRIC ACID MONOHYDRATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "for oral administration" ], "package_label_principal_display_panel": [ "package insert" ], "indications_and_usage": [ "① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) and put into mouth. ② Goggle it thoroughly all over the inner mouth about 10 seconds. ③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out" ], "set_id": "03042aa5-fb3b-4057-855b-84b7237eaeb1", "id": "665bdafc-72a5-4341-a4c2-2cf98175c1bd", "active_ingredient": [ "sodium fluoride" ] }, { "effective_time": "20091111", "purpose": [ "Active ingredients (in each 5 mL tsp) Purposes Chlorpheniramine maleate, USP 1 mg Antihistamine Dextromethorphan HBr, USP 7.5 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions? 877-434-2036" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each teaspoon contains: sodium 2 mg store at 20°-25°C (68°-77°F)" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold 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": "03401433-923e-4577-ba58-9087515c8053", "id": "3c3797ea-03dd-41d3-8f2d-bcd80ee1c040", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each 5 mL tsp) Purposes Chlorpheniramine maleate, USP 1 mg Antihistamine Dextromethorphan HBr, USP 7.5 mg Cough suppressant" ], "dosage_and_administration_table": [ "
age dose
under 6 years do not use
6 to under 12 years 1-2 tsp. (5-10 mL) every 6 hours
" ], "inactive_ingredient": [ "Inactive ingredients artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose." ], "warnings": [ "Warnings Do not use to sedate a child or to make a child sleepy 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 the child has trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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": [ "Cough and Cold Chlorpheniramine Maleate and Dextromethorphan Hydrobromide Chlorpheniramine Maleate Chlorpheniramine Dextromethorphan Hydrobromide Dextromethorphan Fruit Citric Acid Monohydrate FD&C RED NO. 40 Glycerin Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose Reddish-Pink" ], "ask_doctor": [ "Ask a doctor before use if the child has trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 4 doses in any 24-hour period to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device age dose under 6 years do not use 6 to under 12 years 1-2 tsp. (5-10 mL) every 6 hours" ], "spl_unclassified_section": [ "COUGH & COLD LONG-ACTING Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use to sedate a child or to make a child sleepy 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 tsp) Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Carton CHILDREN'S ACCU DIAL ROTATING DOSING LABEL Cough & Cold Long-Acting ACCURATE DOSING BY WEIGHT Chlorpheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) RELIEVES Cough: Up to 8 Hours Runny Nose For Ages 6 to under 12 Compares to Children's Robitussin ® Cough & Cold Long-Acting. FRUIT PUNCH FLAVOR 4 FL. OZ. (118 mL) NDC 45014-151-04 Principal Display Panel - 118 mL Carton" ], "purpose_table": [ "
Active ingredients (in each 5 mL tsp) Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
" ] }, { "effective_time": "20121109", "purpose": [ "PURPOSES Pain reliever/Fever reducer Antihistamine Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "QUESTIONS OR COMMENTS? Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "OTHER INFORMATION each teaspoon contains: sodium 2 mg store at 20 -25°C (68 -77°F) dosage cup provided" ], "indications_and_usage": [ "USES temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headache nasal congestion sore throat fever cough minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0374b3cf-2742-c082-6eb2-3333531e940c", "id": "4f681cb1-403b-45e1-9361-1f7f23951653", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if user is taking any other pain reliever/fever reducer taking sedatives or tranquilizers" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH 5 ML TSP) Acetaminophen, USP 160 mg Chlorpheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 5 mg Phenylephrine HCl, USP 2.5 mg" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 4 teaspoons every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous citric acid, artificial & natural flavors, FD&C red no. 40, glycerin, lactic acid, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose" ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if user takes more than 5 doses 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 to sedate a child or to make a child sleepy if user is 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. with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if user is taking any other pain reliever/fever reducer taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur 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. 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": [ "ROBITUSSIN NIGHT TIME COUGH, COLD AND FLU acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Red liquid" ], "ask_doctor": [ "Ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS do not take more than 5 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 4 teaspoons every 4 hours children under 12 years do not use" ], "spl_unclassified_section": [ "DRUG FACTS" ], "stop_use": [ "Stop use and ask a doctor if user gets nervous, dizzy, or sleepless pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur" ], "do_not_use": [ "Do not use to sedate a child or to make a child sleepy if user is 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. with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure." ], "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. See New Dosing Information Adult Robitussin Night Time Cough, Cold, and Flu Acetaminophen >> Pain reliever/Fever reducer Chlorpheniramine maleate >> Antihistamine Dextromethorphan HBr >> Cough suppressant Phenylephrine HCl >> Nasal decongestant RELIEVES: Cough Body Aches/Fever Headache Sore Throat Stuffy Nose Runny Nose Sneezing For Ages 12 & Over Alcohol-Free 4 FL OZ (118 mL) Robitussin Knows Choosing the right product is important. Robitussin has different products for adults and children. GREEN Boxes – Ages 12 & Over RED Boxes – Ages Under 12 Use as directed. DOSAGE CUP INCLUDED Wyeth Consumer Healthcare Madison, NJ 07940 U.S.A. ©2009 Wyeth For most recent product information, visit www.robitussin.com PARENTS: Learn about teen medicine abuse – www.StopMedicineAbuse.org Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. Robitussin Night Time Cough, Cold & Flu Packaging" ] }, { "effective_time": "20130513", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (26.9%), BENZOIC ACID, POLOXAMER 407, SODIUM BENZOATE, CARAMEL." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-842-7886" ], "spl_product_data_elements": [ "SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL BENZOIC ACID POLOXAMER 407 SODIUM BENZOATE CARAMEL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS" ], "set_id": "03d2b7f9-6bd8-4aba-a4ed-f80be9a83469", "id": "7ccbff24-3c70-4df1-89fd-1a66895f36af", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20151230", "inactive_ingredient": [ "INACTIVE INGREDIENTS: SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT." ], "keep_out_of_reach_of_children": [ "WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD." ], "purpose": [ "PURPOSE: ANTICAVITY" ], "warnings": [ "WARNINGS: IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "spl_product_data_elements": [ "Go Smile PM SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM BENZOATE SACCHARIN SODIUM VALERIAN" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "DIRECTIONS: ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR." ], "package_label_principal_display_panel": [ "GO SMiLE PM 1.0 ozTube_V5_7_11 GO SMiLE PM 3.5 ozTube_V4_7_11" ], "indications_and_usage": [ "PURPOSE: ANTICAVITY" ], "set_id": "03eb5f93-d683-4a7c-9946-051a8960804e", "id": "a301581f-f1c8-4739-9992-80d9096e3604", "active_ingredient": [ "ACTIVE INGREDIENTS: SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE 2 IN 1 DANDRUFF GREEN APPLE PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE DIMETHICONE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE SODIUM XYLENESULFONATE CETYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) SODIUM CHLORIDE MAGNESIUM SULFATE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL ALMOND OIL CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "040315ce-0bd9-4ad9-85a7-048879ff4381", "id": "b27e7eff-8fd5-47e1-bdb8-3ff137ff1e8c", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20091105", "inactive_ingredient": [ "Inactive Ingredients Sorbitol, Silica, Water, Glycerin, Sodium Laurel Sulphate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carrageenan, Mica, FDC Blue No. 1." ], "purpose": [ "Use: Helps protect against cavities." ], "warnings": [ "As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact the Poison Control Center immediately." ], "spl_product_data_elements": [ "Walgreens Anticavity and Antigingivits Whitening Fluoride Toothpaste Anticavity and Antigingivitis Whitening Fluoride Sodium Fluoride FLUORIDE ION Sorbitol SILICON DIOXIDE Water Glycerin SODIUM LAURYL SULFATE Zinc Citrate Titanium Dioxide CROSCARMELLOSE SODIUM SODIUM BENZOATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM HYDROXIDE Carrageenan FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children 6 years or older Brush Teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist. Do not swallow Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 6 years Ask a dentist or physician." ], "package_label_principal_display_panel": [ "Principal Display Panel Anticavity and Antigingivitis Compare to Colgate WHITENING Fluoride Toothpaste Fights Tartar Build-up NET WT 6.4 oz (181.4 g) Whitens Teeth image of container" ], "set_id": "0434b3a5-cb47-4b39-9173-abe28c6433c8", "id": "57b1a2f3-8c90-4b32-8533-894237cf293d", "active_ingredient": [ "ACTIVE INGREDIENTS Sodium Fluoride 0.234% (0.15% w/v fluoride ion..........................Anticavity toothpaste" ], "dosage_and_administration_table": [ "
Adults and children 6 years or older Brush Teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist. Do not swallow
Children between 6 and 12 years To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
Children under 6 years Ask a dentist or physician.
" ] }, { "effective_time": "20110218", "inactive_ingredient": [ "Inactive Ingredients Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose gum, Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin" ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. Stop and ask a dentist if problem persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children ." ], "spl_product_data_elements": [ "Western Family Sensitive Whitening Fluoride Potassium Nitrate and Sodium Fluoride POTASSIUM NITRATE POTASSIUM CATION SORBITOL SILICON DIOXIDE WATER SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM BENZOATE SODIUM PHOSPHATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM FLUORIDE FLUORIDE ION" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children Brush teeth for at least one minute, preferably after 12 years and older each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas. Children under Consult a dentist or doctor. 12 years of age Other information Store in a cool, dry place." ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "USE builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact aids in the prevention of dental cavities" ], "set_id": "046dd282-fcd6-4fce-b636-5d6f576d6e72", "id": "63096f4e-6f42-4006-9252-5b2330b6912f", "active_ingredient": [ "Active Ingredient Potassium Nitrate 5%..................Antihypersensitivity Sodium Fluoride 0.243% (0.15% w/v fluoride ion).......Anticavity Toothpaste" ] }, { "effective_time": "20131203", "inactive_ingredient": [ "Inactive ingredients Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose" ], "purpose": [ "Purpose Anti-gas" ], "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 Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "questions": [ "Questions or comments? 1-800-Walgreens (1-800-925-4733)" ], "spl_product_data_elements": [ "Infants Gas Relief Non-Staining Formula DIMETHICONE DIMETHICONE DIMETHICONE SODIUM BENZOATE CITRIC ACID MONOHYDRATE HYPROMELLOSES CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) SUCRALOSE VANILLIN SODIUM CITRATE WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well before using all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle and dispense liquid slowly into baby's mouth, toward the inner cheek. dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids for best results, clean syringe after each use and replace original cap Age (yr) Weight (lb) Dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY: WALGREEN CO. 200 WILMOT ROAD DEERFIELD, IL 60015" ], "storage_and_handling": [ "Other information Do not use if preprinted seal around the bottle is torn or missing store at room temperature do not freeze see bottom panel for lot number and expiration date" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 2-Bottle Carton TWIN PACK X 1 FL OZ = 2 FL OZ Well at Walgreens WALGREENS PHARMACIST RECOMMENDED ‡ Infants' Gas Relief Simethicone 20 mg/Dose Anti-Gas • Nonstaining formula • No alcohol • No saccharin • No artificial flavor • New dosing syringe design 200 DOSES Compare to Infants' Mylicon ® Drops active ingredient ‡‡ 2-1 FL OZ (30 mL) BOTTLES TOTAL 2 FL OZ (60 mL) Principal Display Panel - 2-Bottle Carton" ], "indications_and_usage": [ "Uses Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods." ], "set_id": "049dbb4c-39b3-49aa-ae63-468693309793", "id": "e88ebb97-08d3-46d7-921c-9812a1a65360", "active_ingredient": [ "Active ingredient (in each 0.3 mL) Simethicone 20 mg" ], "dosage_and_administration_table": [ "
Age (yr) Weight (lb) Dose
infants under 2 under 24 0.3 mL
children over 2 over 24 0.6 mL
" ] }, { "effective_time": "20150604", "inactive_ingredient": [ "INACTIVE INGREDIENT INACTIVE INGREDIENTS: Water, Glycerin, Cyclopentasiloxane, Butylene Glycol, Niacinamide, PEG/PPG-17/6 Copolymer, Ethylhexyl Palmitate, 1,2-Hexandiol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-20 Methyl Glucose Sesquistearate, Carbomer, Tromethamine, Titanium Dioxide (CI 77891), Phexnoyethanol, Cetearyl Alcohol, Polysorbate 60, Dimethiconol, Mica (CI 77019), Fragrance, Xanthan Gum, Caprylyl Glycol, Silica, Dipotassium Glycyrrhizate, Ethylhexylglcerin, Calcium Aluminum Borosilicate, Disodium EDTA, Anthemis Nobilis Flower Water, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Nelumbo Nucifera Flower Extract, JAsminum Officinale (Jasmine) Flower/Leaf Extract, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Rose Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Tin Oxide (CI 77861), Ceratonia Siliqua (Carob) Seed Extract, Robinia Pseudoacacia Flower Extract, Benzyl Alcohol, Sodium Benzoate, Dehydroacetic Acid, Citric Acid" ], "purpose": [ "PURPOSE PURPOSE: Skin Protectant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes." ], "spl_product_data_elements": [ "it Radiant Brightening Eye Dimethicone Dimethicone DIMETHICONE Water Glycerin" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Apply sparingly around eye area with fingertips, using a gentle patting motion." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS & USAGE Apply sparingly around eye area with fingertips, using a gentle patting motion." ], "set_id": "04c19d15-5aea-4e57-8e8b-6ac37ed99c20", "id": "9c28e4f9-b61d-492e-b272-ad5bf4e32271", "active_ingredient": [ "ACTIVE INGREDIENT ACTIVE INGREDIENT: Dimethicone (1.0%)" ] }, { "effective_time": "20121219", "inactive_ingredient": [ "Inactive ingredients 1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time" ], "spl_product_data_elements": [ "NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE CYCLOMETHICONE 5 WATER PEG-10 DIMETHICONE (600 CST) PENTYLENE GLYCOL STEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER PHENYL TRIMETHICONE PEG-40 STEARATE SODIUM DIHYDROXYCETYL PHOSPHATE HYDROGENATED PALM GLYCERIDES CITRIC ACID MONOHYDRATE CETOSTEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL TROPOLONE CHLORPHENESIN XANTHAN GUM POTASSIUM SORBATE SODIUM BENZOATE TETRAHEXYLDECYL ASCORBATE UBIDECARENONE EDETATE DISODIUM METHYLISOTHIAZOLINONE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SQUALANE POLYSORBATE 60" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m.; wear long-sleeved shirts, pants, hats, and sunglasses." ], "stop_use": [ "Stop use and ask a doctor if rash occurs." ], "spl_unclassified_section": [ "Distributed by OMP, Inc., Long Beach, CA 90806" ], "storage_and_handling": [ "Other information Store at controlled room temperature: 15°C–25°C (59°F–77°F). Protect this product from excessive heat and direct sun." ], "do_not_use": [ "Do not use on damaged or broken skin." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 85 g Tube Label OBAGI NU-DERM ® Sun Shield MATTE Broad Spectrum SPF 50 Sunscreen Lotion PA+++ Net wt. 3 oz. (85 g.) PRINCIPAL DISPLAY PANEL - 85 g Tube Label" ], "indications_and_usage": [ "Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "04ca07d8-46dc-469c-8482-ffcb3d5bc943", "id": "c9ef85c0-cdaa-43ff-8ea3-803e30fb1bb4", "active_ingredient": [ "Active ingredients Octinoxate 7.5%, Zinc Oxide 10.5%" ] }, { "effective_time": "20140822", "inactive_ingredient": [ "Inactive Ingredients Alcohol, carbomer, equisetum arvense extract, FD&C Blue No. 1, limonene, linalool, malaleuca leucadendron cajaput oil, potassium sorbate, PPG-1-PEG-9 lauryl glycol esther, rosmarinus officinals malaleuca, sodium benzoate, sodium hydroxide, thymus vulgaris, water." ], "purpose": [ "Active Ingredients Purpose Camphor 3% Pain Reliever Menthol 2.2% Pain Reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately." ], "warnings": [ "Warnings For external use only Do not use on wounds, damaged skin or irritated areas a heating pad on treated area When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days conditions clear up and occur again within a few days. If pregnant or breast-feeding ask a healthcare professional before use. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately." ], "when_using": [ "When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly" ], "spl_product_data_elements": [ "One Gel Sport Pain relieving Camphor (Synthetic) and Menthol Camphor (Synthetic) Camphor (Synthetic) Menthol Menthol Alcohol equisetum arvense branch fd&c blue no. 1 linalool, (+/-)- potassium sorbate sodium benzoate sodium hydroxide water" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and Children 7 years of age and older: apply to the affected area up to 3 times daily, as needed." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a healthcare professional before use." ], "spl_unclassified_section": [ "Phyto Creativ Drug Facts", "Distributed by One Gel USA Inc. Lighthouse Point, FL 33064" ], "stop_use": [ "Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days conditions clear up and occur again within a few days." ], "do_not_use": [ "Do not use on wounds, damaged skin or irritated areas a heating pad on treated area" ], "active_ingredient_table": [ "
Active Ingredients Purpose
Camphor 3% Pain Reliever
Menthol 2.2% Pain Reliever
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label one gel Sport TWIST CAP TO OPEN Laboratoires Phyto Creativ USA Paraben free Phenoxyethanol free Essential oils ①™ one gel Sport Pain Relieving Gel NET WT : 3.38 oz. (100 ml) Principal Display Panel - 100 ml Bottle Label" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains of muscles and joints" ], "set_id": "04d9d757-6c99-480c-bab3-eb38ab1992a4", "id": "5ac0eadd-ce2d-47df-9f86-9513defd288e", "purpose_table": [ "
Active Ingredients Purpose
Camphor 3% Pain Reliever
Menthol 2.2% Pain Reliever
" ], "active_ingredient": [ "Active Ingredients Purpose Camphor 3% Pain Reliever Menthol 2.2% Pain Reliever" ] }, { "effective_time": "20110321", "inactive_ingredient": [ "Inactive Ingredients: Sorbitol, Hydrated Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Sodium Saccharin" ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Western Family Cavity Control Sodium Fluoride Sodium Fluoride Fluoride Ion SORBITOL SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 300 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE TITANIUM DIOXIDE SODIUM PYROPHOSPHATE SACCHARIN SODIUM Cool Fresh Paste" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children Brush teeth throughly, preferably after 2 years and older each meal, or at least twice a day, or as directed by your dentist. Do not swallow. Children under To minimize swallowing, use a pea-sized 6 years of age amount and supervise brushing until good habits are established. Children under 2 years Ask a dentist or physician." ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "Helps protect against cavities." ], "set_id": "04de1ef4-3212-4998-bd5e-f2fb556637b3", "id": "62798515-110d-472f-a027-11cc75387654", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste" ] }, { "effective_time": "20110826", "inactive_ingredient": [ "Inactive Ingredients anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose" ], "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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in 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 sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children" ], "questions": [ "Questions? Adverse drug event call (888) 933-3222" ], "spl_product_data_elements": [ "Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Citric Acid Monohydrate Sodium Benzoate Glycerin polyethylene glycols sodium citrate sodium chloride" ], "ask_doctor": [ "Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. take every 4 to 6 hours do not take more than 6 doses in 24 hours children under 2 years: do not use children 2 to 5 years: do not use unless directed by a doctor children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information each teaspoon contains: sodium 14 mg store between 20 to 25°C (68 to 77°F) protect from light store in outer carton until contents sused." ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton Children's ALLERGY RELIEF Health Select ® Diphenhydramine HCl Antihistamine For Temporary Relief of: Itchy, Watery Eyes Itchy Throat Runny Nose Sneezing For Ages 12 and Older Alcohol Free NET 4 FL OZ (118 ML) NDC 49743-3001-1 Principal Display Panel" ], "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": "04e38dab-16b1-4848-9dcb-92e9f67e6119", "id": "dfcebe7c-7215-47cf-9e2c-9822439eb207", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each 5 mL tsp) Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20090827", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ). Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients ). Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ).", "Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers )." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "0505fe62-ac59-475e-8c94-1933398be580", "id": "30004e84-7a7b-46ac-b6fe-bd1835dd9fcf", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.", "Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients )." ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate CODEINE PHOSPHATE CODEINE PROMETHAZINE HYDROCHLORIDE PROMETHAZINE ALCOHOL ASCORBIC ACID CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181652 R1/09-R4 Relabeling of \"Additional Barcode label\" by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "how_supplied": [ "HOW SUPPLIED Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in: 4 fluid ounce (118 mL) NDC 54868-1029-1 , 8 fluid ounce (237 mL) NDC 54868-1029-0 . and pint (473 mL) NDC 54868-1029-2 ." ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Promethazine with Codeine Syrup This is an image of the label for Promethazine with Codiene Syrup." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames." ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps" ], "spl_product_data_elements": [ "Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Temporary Relief of Occasional Constipation Compare to the Active Ingredient of Ducolax®* Gentle Laxative Bisacodyl Stimulant Laxative 25 Tablets 5 mg each TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF00000 50844 REV0510B32765 Our Family 44-327-56 Product Label" ], "indications_and_usage": [ "Use(s) relieves occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "050780d6-b1bd-4717-b517-527b86bb9dfa", "id": "aa329d94-d60c-4a9b-aebd-d707ba6bedb1", "active_ingredient": [ "Active ingredient Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20130110", "purpose": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning )" ], "questions": [ "Questions or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if bottle wrap, or foil inner seal imprinted \"Safety Seal®\" is broken or missing see bottom panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever" ], "set_id": "050f7ef8-60fc-4e8f-ae9c-3a7c5682f96f", "id": "82781d0a-7f2e-45c7-9c18-2c688b587f14", "active_ingredient": [ "Active ingredients (in each 5 mL = 1 teaspoon) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 years do not use
36-47 4 to 5 years 1 tsp or 5 mL
48-95 6 to 11 years 2 tsp or 10 mL
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, xanthan gum" ], "warnings": [ "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 vomiting, consult a doctor promptly. Do not use with any other product containing acetaminophen in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "CHILDRENS TYLENOL PLUS COUGH and SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide Acetaminophen acetaminophen Dextromethorphan Hydrobromide dextromethorphan acesulfame potassium anhydrous citric acid D&C Red no. 33 FD&C Red no. 40 glycerin high fructose corn syrup cellulose, microcrystalline carboxymethylcellulose sodium water sodium benzoate sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if the child has a persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not give more than directed (see overdose warning ) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tsp or mL) under 36 under 4 years do not use 36-47 4 to 5 years 1 tsp or 5 mL 48-95 6 to 11 years 2 tsp or 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other product containing acetaminophen in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Dextromethorphan HBr 5 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Directions NDC 50580-247-04 Children's TYLENOL ® Fever Reducer, Pain Reliever, Cough Suppressant Plus COUGH & SORE THROAT CONTAINS 2 INGREDIENTS: • Fever & Sore Throat Acetaminophen • Cough Dextromethorphan HBr CHERRY FLAVOR 4 FL OZ (120mL) ORAL SUSPENSION Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each 5 mL = 1 teaspoon) Purpose
Acetaminophen 160 mg Pain reliever/fever reducer
Dextromethorphan HBr 5 mg Cough suppressant
" ] }, { "effective_time": "20130819", "inactive_ingredient": [ "INACTIVE INGREDIENT WATER/AQUA/EAU, ISOHEXADECANE, HEXYL LAURATE, MICA, GLYCERIN, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, ASCORBYL PALMITATE, BETAINE, CARBOMER, GLYCERYL STEARATE, HYDROLYZED VEGETABLE PROTEIN, LECITHIN, MAGNESIUM ALUMINUM SILICATE, PEG-100 STEARATE, POLYGLYCERYL-10 MYRISTATE, SODIUM HYDROXIDE, TOCOPHERYL ACETATE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM DEHYDROACETATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891)." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children." ], "purpose": [ "OTC - PURPOSE Provides SPF 15 sun protection." ], "warnings": [ "WARNINGS For external use only" ], "when_using": [ "OTC - WHEN USING keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE NATURAL OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER ISOHEXADECANE HEXYL LAURATE MICA GLYCERIN POLYGLYCERYL-4 ISOSTEARATE POTASSIUM CETYL PHOSPHATE ASCORBYL PALMITATE BETAINE MAGNESIUM ALUMINUM SILICATE PEG-100 STEARATE SODIUM HYDROXIDE CHLORPHENESIN PHENOXYETHANOL POTASSIUM SORBATE SODIUM BENZOATE SODIUM DEHYDROACETATE LIGHT BEIGE" ], "description": [ "DESCRIPTION Makeup that feels like your own skin, only better. Light, breathable formula smooths on seamlessly for a naturally luminous look that lasts all day. Minimizes the look of pores and imperfections immediately and over time with continued use. Hydro-pigment color technology, vitamins and antioxidants protect and perfect, so skin looks beautifully even-toned and flawless." ], "openfda": {}, "version": "1", "stop_use": [ "OTC - STOP USE Stop use and ask a doctor if rash occurs" ], "do_not_use": [ "OTC - DO NOT USE Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "FLAWLESS FINISH PERFECTLY NUDE MAKEUP SPF 15" ], "indications_and_usage": [ "INDICATIONS & USAGE smooth onto face." ], "set_id": "05429de7-a473-4124-92eb-b85788e096a8", "id": "b9daf843-0207-496b-bdf7-5695b4499540", "active_ingredient": [ "OTC - ACTIVE INGREDIENT OCTINOXATE 4.00%..............Sunscreen TITANIUM DIOXIDE 1.26%....Sunscreen" ] }, { "effective_time": "20140924", "purpose": [ "Active ingredients (in each tablet) Purpose Chlorpheniramine maleate 4 mg Antihistamine Dextromethorphan hydrobromide 30 mg Cough suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury." ], "when_using": [ "When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? Call 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time, Monday through Friday" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) protect from excessive moisture" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold" ], "set_id": "055b29f1-7e07-4787-9342-ab5629905e4a", "id": "97d99cb7-94b5-48c7-bbf5-4d8da9ad3645", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purpose Chlorpheniramine maleate 4 mg Antihistamine Dextromethorphan hydrobromide 30 mg Cough suppressant" ], "inactive_ingredient": [ "Inactive ingredients acacia, calcium sulfate, carnauba wax, croscarmellose sodium, D&C red No. 27 aluminum lake, FD&C yellow No. 6 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical ink, povidone, sodium benzoate, sugar, talc, titanium dioxide, white wax" ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury." ], "spl_product_data_elements": [ "Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine Chlorpheniramine maleate and Dextromethorphan hydrobromide Chlorpheniramine maleate Chlorpheniramine Dextromethorphan hydrobromide Dextromethorphan acacia calcium sulfate carnauba wax croscarmellose sodium D&C red no. 27 FD&C yellow no. 6 aluminum oxide lactose magnesium stearate cellulose, microcrystalline povidones sodium benzoate sucrose talc titanium dioxide white wax CC" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not exceed recommended dose adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours children under 12 years of age: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by MSD Consumer Care, Inc. PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg Antihistamine
Dextromethorphan hydrobromide 30 mg Cough suppressant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 16 Tablet Carton NDC 11523-3601-1 Coricidin ® HBP Decongestant-free COLD RELIEF for people with HIGH BLOOD PRESSURE Cough Suppressant, Antihistamine COUGH & COLD Relieves: Cough Runny Nose Sneezing 16 TABLETS American Heart Association Health Information Enclosed PRINCIPAL DISPLAY PANEL - 16 Tablet Carton" ], "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Chlorpheniramine maleate 4 mg Antihistamine
Dextromethorphan hydrobromide 30 mg Cough suppressant
" ] }, { "effective_time": "20141014", "inactive_ingredient": [ "Water, Caprylic Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes,Polyglyceryl-2 Sesquioleate, Glycerin, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica Seed Oil, Aloe Barbadensis Leaf Juice(1), Polyhydroxystearic Acid, Echinacea Purpurea Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Camilla Sinensis Leaf Extract (1), Ginkgo Biloba Leaf Extract (1), Brassica Campestris (Rapeseed) Seed Oil, Alumina, Coco-Caprylate/Caprate, Magnesium Sulfate, Sodium Chloride, Sorbitan Sesquioleate, Stearic Acid, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Alba Mineral Sunscreen Sport SPF45 Broad Spectrum Zinc Oxide, Titanium Dioxide ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL POTASSIUM SORBATE SODIUM BENZOATE ALOE VERA LEAF TITANIUM DIOXIDE TITANIUM DIOXIDE ISOAMYL LAURATE COCONUT ALKANES GLYCERIN POLYGLYCERYL-3 RICINOLEATE CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL WATER POLYGONUM AVICULARE TOP SHEA BUTTER GREEN TEA LEAF GINKGO BRASSICA RAPA SUBSP. OLEIFERA OIL ALUMINUM OXIDE COCO-CAPRYLATE/CAPRATE MAGNESIUM SULFATE SODIUM CHLORIDE SORBITAN SESQUIOLEATE STEARIC ACID ECHINACEA PURPUREA ROOT POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Cream. Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If uses as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "05680826-a5ee-6685-e054-00144ff88e88", "id": "05680826-a5ef-6685-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Zinc Oxide 9.0% Titanium Dioxide 7.0%" ] }, { "effective_time": "20140623", "inactive_ingredient": [ "Inactive ingredients Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose" ], "purpose": [ "Purpose Analgesic Cough Suppressant Expectorant Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed recommended dosage Liver warning: This product contains Acetaminophen. Sever liver damage may occur if Adult takes more than 6 doses in 24 hours, which is the maximum daily amount Child takes more than 5 doses in 24 hours Taken with other drugs containing Acetaminophen Adult has 3 or more alcoholic drinks everyday while using this product Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician" ], "spl_product_data_elements": [ "Broncomar Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALOE VERA WHOLE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 HYDROXYMETHYL CELLULOSE WATER SODIUM BENZOATE SORBITOL SUCRALOSE PROPYLENE GLYCOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not take more than 6 doses in any 24-hour period Age Dose Adults and children 12 years and over 10 mL (2 tsps) every 6 hours Children 6 to under 12 years of age. 5 mL (1 tsps) every 6 hours Children under 6 years of age Do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask the doctor if Nervoisness, dizziness or sleeplessness occurs. Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition" ], "do_not_use": [ "Do not use If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor avoid alcoholic beverages while you are taking this product do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist. Ask the 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 heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland. The user has liver disease The user is taking the blood thinning drug Warfarin." ], "package_label_principal_display_panel": [ "BroncomarEx" ], "indications_and_usage": [ "Uses For temporary relief of bronchial and nasal congestion Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive. Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold" ], "set_id": "058cdaf3-ed98-44b2-9ecc-fd810dcac12e", "id": "c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae", "active_ingredient": [ "Acvtive ingredients: (in 10 ml) Purpose Acetaminophen 200 mg ............................. Analgesic Dextromethorphan HBr 13.33 mg ................... Cough Suppressant Guaifenesin 200 mg ................................... Expectorant Phenylephrine HCl 5 mg ............................. Decongestant" ] }, { "effective_time": "20131004", "inactive_ingredient": [ "Inactive Ingredients Calcium Carbonate, Sorbitol, Demineralized Water, Sodium Lauryl Sulphate, Hydrated Silica, Sod. CMC, Flavor, Sodium Silicate, Sodium Benzoate, Sodium Saccharin" ], "purpose": [ "Purpose AntiCavity Toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately" ], "warnings": [ "Warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately" ], "spl_product_data_elements": [ "Smarth Extra Strength Minty Fresh Sodium monofluorophosphate Sodium monofluorophosphate Fluoride ion Calcium Carbonate Sorbitol Water Sodium Lauryl Sulfate Hydrated Silica Sodium Silicate Sodium Benzoate Saccharin Sodium Carboxymethylcellulose Sodium" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor Children under 6 years of age: Do not use unless directed by a doctor or dentist" ], "spl_unclassified_section": [ "Drug Facts" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 181g Tube Carton SMARTH ™ Extra Strength Fluoride Toothpaste MINTY FRESH NET WT 6.4 Oz [181g] Principal Display Panel - 181g Tube Carton" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "0599719b-ea4b-42b5-8f6b-182e39ddefa3", "id": "8cd7c69c-0b93-4bd4-9643-ec63c386d89f", "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)" ] }, { "effective_time": "20120830", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Glycerin, Silica, Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dimethyl Capramide, Hydrogenated Palm Glycerides, Polysiloxane 11, Dimethylmethoxy Chromanol, Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Diaminopropionoyl Tripeptide-33, Caprylyl Glycol, Disodium EDTA, Xanthan Gum, Methylisothiazolinone, Hexylene Glycol, Isohexadecane, Polysorbate 80, Vitis Vinifera Fruit Cell Extract, Isomalt, Prunus Armeniaca (Apricot) Fruit Extract, Lecithin, Sodium Benzoate, Aniba Rosaeodora (Rosewood) Wood Extract, Citrus Aurantifolia (Lime) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Vanilla Planifolia Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Cocos Nucifera (Coconut) Oil" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free (800) 630-4710" ], "spl_product_data_elements": [ "Light Day Sunscreen Broad Spectrum SPF 37 Avobenzone, Octinoxate and Octocrylene AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE WATER ALKYL (C12-15) BENZOATE GLYCERIN SILICON DIOXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE POTASSIUM CETYL PHOSPHATE DIMETHICONE CYCLOMETHICONE 5 CYCLOMETHICONE 6 DIMETHYL CAPRAMIDE HYDROGENATED PALM GLYCERIDES SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) CAPRYLYL GLYCOL EDETATE DISODIUM XANTHAN GUM METHYLISOTHIAZOLINONE HEXYLENE GLYCOL ISOHEXADECANE POLYSORBATE 80 ISOMALT APRICOT SODIUM BENZOATE ANIBA ROSAEODORA WOOD LIME PEEL ORANGE PEEL VANILLA CITRUS MAXIMA FRUIT RIND COCONUT OIL EGG PHOSPHOLIPIDS WINE GRAPE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally to skin 15 minutes before sun exposure and as needed. use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirt, pants, hats, and sunglasses" ], "spl_unclassified_section": [ "Other Information protect this product from excessive heat and direct sun." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Light Day Sunscreen for face & neck Broad Spectrum SPF37 Advanced Professional Skincare 2 fl oz (59 ml) Circadia by Dr. Pugliese, Inc. 8371 Route 183 Bethel, PA 19507 Circadia.com Bottle Label Bottle Label" ], "indications_and_usage": [ "Uses Helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "05a63c49-1974-4b26-b070-b32813cb0852", "id": "05a63c49-1974-4b26-b070-b32813cb0852", "active_ingredient": [ "Active ingredient Avobenzone 3.0% Octinoxate 7.5% Octocrylene 2.8%" ] }, { "effective_time": "20130503", "inactive_ingredient": [ "INACTIVE INGREDIENTS / INGREDIENTS INACTIFS: Water/Eau, Cyclopentasiloxane, Isododecane, Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, Polymethylsilsesquioxane, Glycerin, HDI/Trimethylol Hexyllactone, Crosspolymer, Propanediol,Dimethicone, Hydrogenated Castor Oil, Magnesium Sulfate, Ribose, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Alaria Esculenta Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Extract Marrubium Vulgare Extract, Hexapeptide-10, Tocopheryl Acetate, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Aminobutyric Acid, Caprylic/Capric Triglyceride, Sodium Hyaluronate, Sodium Chloride,Ethylhexylglycerin, Caprylyl Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate. MAY CONTAIN / PEUT CONTENIR: Titanium Dioxide (CI77891), Iron Oxides (CI77491, CI77492, CI77499)" ], "purpose": [ "Purpose: Makeup with SPF15. Gives sunburn protection." ], "warnings": [ "Directions: Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if signs of skin irritation develop or increase. If irritation persists, consult a health care practitioner. If swallowed, get medical help or contact a Poison Control Center right away. For external use only. Keep out of reach of children." ], "spl_product_data_elements": [ "Perfecting Liquid Foundation Golden Beige SPF 15 Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MAGNESIUM SULFATE, UNSPECIFIED SODIUM CHLORIDE GLYCERIN GREEN TEA LEAF HYALURONATE SODIUM THYME MARRUBIUM VULGARE POTASSIUM SORBATE SODIUM BENZOATE .GAMMA.-AMINOBUTYRIC ACID ETHYLHEXYLGLYCERIN OAT CAPRYLYL GLYCOL ISODODECANE DIMETHICONE ALPHA-TOCOPHEROL ACETATE HYDROGENATED CASTOR OIL TETRAHEXYLDECYL ASCORBATE VITAMIN A PALMITATE MAGNESIUM OXIDE MEDIUM-CHAIN TRIGLYCERIDES TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE" ], "description": [ "Multitasking liquid foundation with skin-firming properties helps lift the appearance of facial contours, smooth and even skin tone, while providing sun protection." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: Apply prior to sun exposure. Dispense foundation and apply to entire face. Blend well with fingertips or sponge." ], "package_label_principal_display_panel": [ "PERFECTING LIQUID FOUNDATION WITH SPF 15 FOND DE TEINT PERFECTEUR LIQUIDE AVEC FPS 15 ARBONNE 1 fl. oz./30ml NPN:80014990 Arbonne Foundation Carton" ], "set_id": "05e7e2e1-12f0-4ac5-872a-0fd3db1da751", "id": "3b2b1823-fe4b-4b4a-8150-69feb5f94689", "active_ingredient": [ "ACTIVE INGREDIENT / INGREDIENT ACTIF: Zinc Oxide 10% / Oxyde de zinc a 10%" ] }, { "effective_time": "20120604", "inactive_ingredient": [ "Inactive Ingredients Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Glycol Distearate, Dimethicone, Fragrance, Melaleuca Alternifolia (tea tree) leaf oil, Carthamus Tinctorius (safflower) seed oil, Mentha Arvensis (wild mint) leaf extract, Cetyl Alcohol, Cocamide MEA, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Hydrogenated Polydecene, Sodium Citrate, Sodium Benzoate, Polyquaternium 10, PEG 7M, Trimethylolpropane Tricaprylate Tricaprate, Citric Acid, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Ammonium Xylenesulfonate, D and C Yellow No. 10, FD and C Blue No. 1." ], "purpose": [ "Purpose Anti-Dandruff" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Warnings For external use only" ], "when_using": [ "When using this product When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions? Questions? 1-800-436-7378 or visit us at www.pertplus.com Made in Canada Distributed by Innovative Brands, LLC under license from Procter and Gamble. Phoenix, AZ 85050 2009" ], "spl_product_data_elements": [ "Pert Plus Dandruff Dismissed Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC Water Ammonium lauryl sulfate Glycol stearate Dimethicone Cetyl Alcohol Sodium Citrate Sodium Benzoate Polyethylene Glycol 7000 Benzyl Alcohol Sodium Chloride CITRIC ACID MONOHYDRATE Methylisothiazolinone FD&C BLUE NO. 1 D&C Yellow No. 10 TEA TREE OIL SAFFLOWER OIL MINT" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: For best results, use at least twice a week or as directed by a doctor. Gently massage into wet hair, lather and rinse. Repeat if desired." ], "stop_use": [ "Stop use Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "Pert Plus Dandruff Dismissed Shampoo plus Conditioner with tea tree oil and wild mint for dandruff control MM1 image of front label" ], "indications_and_usage": [ "Uses Controls the symptoms of dandruff." ], "set_id": "06213c20-4930-41f1-9809-9fdba6fe449a", "id": "0191d839-afc7-4e73-86e7-c8397e4e352a", "active_ingredient": [ "Active Ingredient Active Ingredient Zinc Pyrithione 0.45%" ] }, { "effective_time": "20110510", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water." ], "purpose": [ "Purpose of Brompheniramine maleate: Antihistamine Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant Purpose of Dextromethorphan hydrobromide: Cough Suppressant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsines be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. 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 marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsines be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions Made in USA for Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811" ], "spl_product_data_elements": [ "Q-Tapp DM Elixir Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide Brompheniramine maleate Brompheniramine Pseudoephedrine hydrochloride Pseudoephedrine Dextromethorphan hydrobromide Dextromethorphan anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 glycerin propylene glycol saccharin sodium sodium benzoate sodium citrate sorbitol water grape flavor" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than 4 doses in any 24-hour Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours Children under 6 years DO NOT USE Other information each tsp contains: sodium 2 mg Store at room temperature 20°-25°C (68°-77°F)." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "container label" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis temporarily relieves symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose" ], "set_id": "0654b093-2067-492f-a0bc-647dac430bde", "id": "6c130ae2-6aca-4264-95e3-dc820abb311c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL = 1 tsp) Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL = 1 tsp) Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL = 1 tsp)" ], "dosage_and_administration_table": [ "
Adults and children 12 years and over 20 mL (4 tsp) every 4 to 6 hours
Children 6 years to under 12 years 10 mL (2 tsp) every 4 to 6 hours
Children under 6 years DO NOT USE
" ] }, { "effective_time": "20110126", "inactive_ingredient": [ "Cherry Flavor,Citric Acid,Menthol,Polyethylene Glycol,Propylene Glycol,Purified Water, Sodium Benzoate,Sodium Saccharin,Sorbitol. image of carton" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children, In case of overdose, get medical help or contact a Poison Center immediately" ], "purpose": [ "Purpose Dextromethorphan Hydrobromide Cough Suppressant Guaifenesin Expectorant" ], "warnings": [ "Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product" ], "spl_product_data_elements": [ "Double Tussin Intense Cough Reliever DM Dextromethorphan Hydrobromide / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Guaifenesin POLYETHYLENE GLYCOL SODIUM BENZOATE SORBITOL" ], "ask_doctor": [ "Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma cough is accompanied by excessive phlegm (mucous)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed • Children under 6 years of age: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor Other information store at 15'- 30' C (59'- 86'F)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use" ], "stop_use": [ "Stop use and ask doctor if Symptoms are accompanied by fever, rash or persistent headache cough persists for more than 1 week or tends to recur A persistent cough may be a sign of a serious condition" ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses. temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus • helps make coughs more productive" ], "set_id": "067210f8-03bc-415c-9ec5-cdad04bfb07d", "id": "bea99183-3189-4191-8d09-0c3cb986abc9", "active_ingredient": [ "Active ingredient per 5ml teaspoon Dextromethorphan Hydrobromide 20mg Cough Suppressant Guaifenesin 300mg Expectorant" ] }, { "effective_time": "20130128", "inactive_ingredient": [ "INGREDIENTS CYCLOPENTASILOXANE, WATER, CUCUMIS SATIVUS (CUCUMBER) FRUIT WATER, GLYCERIN, DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, NIACINAMIDE, DIETHYLHEXYL CARBONATE, TALC, PROPYLENE GLYCOL, PEG/PPG-18/18 DIMETHICONE, SIMMONDSIA CHINENSIS (JOJOBA) SEED WAX, ROSA CANINA FRUIT EXTRACT, HIPPOPHAE RHAMNOIDES FRUIT JUICE, PANTHENOL, TOCOPHERYL ACETATE, ALLANTOIN, DIMETHICONE, METHICONE, ALUMINUM HYDROXIDE, FRAGRANCE, TRIDECETH-9, BISABOLOL, LACTIC ACID, PEG-10 DIMETHICONE CROSSPOLYMER, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, BENZYL ALCOHOL, PHENOXYETHANOL. MAY CONTAIN : IRON OXIDES, TITANIUM DIOXIDE." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "WARNING AVOID EYE CONTACT. NOT TO BE SWALLOWED. STOP USE AND CONSULT DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS. KEEP OUT OF REACH OF CHILDREN." ], "when_using": [ "AVOID EYE CONTACT. NOT TO BE SWALLOWED." ], "spl_product_data_elements": [ "Covergirl Natureluxe Silk Foundation SPF10 - 325 Sandstone Titanium Dioxide and Octinoxate Titanium Dioxide Titanium Dioxide Octinoxate Octinoxate CYCLOMETHICONE 5 WATER CUCUMBER FRUIT OIL GLYCERIN SODIUM CHLORIDE NIACINAMIDE DIETHYLHEXYL CARBONATE TALC PROPYLENE GLYCOL SIMMONDSIA CHINENSIS SEED WAX ROSA CANINA FRUIT HIPPOPHAE RHAMNOIDES FRUIT JUICE PANTHENOL ALLANTOIN DIMETHICONE ALUMINUM HYDROXIDE TRIDECETH-9 LEVOMENOL LACTIC ACID CITRIC ACID MONOHYDRATE SODIUM BENZOATE POTASSIUM SORBATE BENZYL ALCOHOL PHENOXYETHANOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS APPLY BEFORE SUN EXPOSURE." ], "stop_use": [ "STOP USE AND CONSULT DOCTOR IF RASH OR IRRITATION DEVELOPS OR LASTS." ], "spl_unclassified_section": [ "PROCTER & GAMBLE, DISTR., HUNT VALLEY, MD 21030" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 ml Tube Label COVERGIRL nature luxe ™ luxury touched by nature SPF 10 sunscreen 325 liquid silk foundation 30 ml (1 fl oz liq.) DIN 02339633 Principal Display Panel - 30 ml Tube Label" ], "set_id": "068d8497-63e0-4e71-a6f0-02e283b16cdf", "id": "b81b9bb4-6e19-4a5f-bb0d-cbae5ce6f99e", "active_ingredient": [ "ACTIVE INGREDIENTS TITANIUM DIOXIDE 2.6%, OCTINOXATE 2%" ] }, { "effective_time": "20150924", "inactive_ingredient": [ "Inactive ingredients Water, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate 20, Allantoin, Disodium EDTA, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Fragrance, Citric Acid, Simethicone" ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Do not use on • deep or puncture wounds • animal bites • serious burns When using this product • do not get into eyes Stop use and ask a doctor if • irritation or redness develops • conditions persist for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product • do not get into eyes" ], "spl_product_data_elements": [ "CVS Triple-Thick Antibacterial Washcloths Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM ALLANTOIN ALOE VERA LEAF ANHYDROUS CITRIC ACID COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE EDETATE DISODIUM LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE POLYSORBATE 20 DIMETHICONE SODIUM BENZOATE WATER" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Washcloths can be used at room temperature or heated in a microwave for extra comfort. Heating instructions: • Place full package in microwave and heat for 45 seconds, then follow washing instructions • If heating a partial package (2 or more cloths), heat for 15 seconds and test temperature to avoid burning skin. Washing instructions: • Gently pull label tab until package opening is exposed • Remove cloths one at a time to cleanse body parts in this order: • Face • Neck and abdomen • Right arm • Left arm • Right leg • Left leg • Back • Groin and buttocks • Allow skin to dry • Dispose of cloth in waste receptacle • Do not flush cloths in toilet" ], "stop_use": [ "Stop use and ask a doctor if • irritation or redness develops • conditions persist for more than 72 hours" ], "storage_and_handling": [ "Other information • Avoid excessive heat. Protect from freezing. • Washcloth: rayon / polyester" ], "do_not_use": [ "Do not use on • deep or puncture wounds • animal bites • serious burns" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel CVS Health NDC: 59779-005-76 Triple-thick ANTIBACTERIAL WASHCLOTHS FOR PERSONAL CLEANSING • Hypoallergenic • Moisturizes & conditions 8 Washcloths 8 in x 8 in (20.3 cm x 20.3 cm) CVS HEALTH ANTIBACTERIAL WASHCLOTHS PDP", "Package Label - Drug Facts Box CVS HEALTH ANTIBACTERIAL WASHCLOTHS DRUG FACTS" ], "indications_and_usage": [ "Uses • helps reduce germs that can potentially cause infection" ], "set_id": "06f2870a-3030-4c56-953f-6fea4bd9024a", "id": "62e5d8ce-3f92-4898-afe4-73c7cd9e947a", "active_ingredient": [ "Active ingredient Benzalkonium Chloride 0.12%" ] }, { "effective_time": "20141106", "inactive_ingredient": [ "Water, Lauryl Glucoside,Glycerin, Sodium Cococ-Silfate, Sodium Lauroyl Glutamate, Acer Saccharum (Sugar Maple) Extract, Aloe Barbadensis Leaf Juice(1), Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract (1), Citrus Limon (Lemon) Fruit Extract, Fragaria Vesca (Strawberry) Fruit Extract (1), Macrocystis Pyrifera Extract, Panax Ginseng Root Extract, Purys Malus (Apple) Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract (1), Vitis Vinifera(Grape) Fruit Extract, Vaccinium Myrtillus Fruit Extract, Citrus Aurantifolia (Lime) Oil (2), Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Grandis (Grapefruit) Peel Oil (2), Citrus Limon (Lemon) Peel Oil (2), Citrus Nobilis (Mandarin Orange) Peel Oil (2), Prunus Amygdalus Dulcis (Sweet Almond) Oil (2), Citric Acid, Decyl Glucoside, Glyceryl Oleate, Sodium Sulfate, Alcohol (1), Phenoxyethanol, Sodium Benzoate, Potassium Sorbate. (1) Certified Organicf Ingredient; (2) For scent only" ], "purpose": [ "Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. I contact occurs, flush throughly with water." ], "spl_product_data_elements": [ "Alba Good and Clean Gentle Acne Wash Salicylic Acid ALPINE STRAWBERRY MACROCYSTIS PYRIFERA ASIAN GINSENG APPLE SALIX ALBA BARK WINE GRAPE LEMON LAURYL GLUCOSIDE SALICYLIC ACID SALICYLIC ACID WATER GLYCERIN SODIUM COCO-SULFATE COCO GLUCOSIDE SODIUM LAUROYL GLUTAMATE ACER SACCHARUM BARK/SAP ALOE VERA LEAF ORANGE PUMMELO BLACKBERRY SUGARCANE BILBERRY CITRUS MAXIMA FRUIT RIND OIL LIME OIL ORANGE OIL LEMON OIL MANDARIN OIL ALMOND OIL CITRIC ACID MONOHYDRATE DECYL GLUCOSIDE GLYCERYL OLEATE SODIUM SULFATE ALCOHOL PHENOXYETHANOL POTASSIUM SORBATE SODIUM BENZOATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Rinse face and neck with water. Squeze cleanser into palm, work into a foamy lather and then massage over the skin. Rinse clean." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "For the treatment of acne." ], "set_id": "07364a19-a71b-23c9-e054-00144ff88e88", "id": "07364a19-a71c-23c9-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Salicylic Acid 1.0%" ] }, { "effective_time": "20150803", "purpose": [ "Purpose Stool softener Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "dosage_forms_and_strengths": [ "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor" ], "dosage_forms_and_strengths_table": [ "
age starting dosage maximum dosage
adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
" ], "indications_and_usage": [ "Drug Facts" ], "set_id": "07653724-015c-4403-a606-b9b8e4582b6d", "id": "b172d975-7f46-41f6-a182-b3938bc88952", "active_ingredient": [ "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients dicalcium phosphate,D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, lecithin, magnesium stearate ,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide ©2012, Purdue Products L.P. Manufactured for: Purdue Products L.P. Stamford, CT 06901-3431 By: Purdue Pharma 575 Granite Court Pickering, ON L1W 3W8, Canada 302887-0A" ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "Senokot-S standardized senna concentrate and docusate sodium SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS D&C YELLOW NO. 10 FD&C YELLOW NO. 6 EGG PHOSPHOLIPIDS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL STARCH, CORN SODIUM BENZOATE TALC TITANIUM DIOXIDE P" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks" ], "warnings_and_cautions": [ "" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "how_supplied": [ "Other information each tablet contains: calcium 10 mg, sodium 4 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)" ], "do_not_use": [ "Do not use if you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Image of Label Image of Label" ] }, { "effective_time": "20141111", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba VE Sunscreen Sport SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide ETHYLHEXYLGLYCERIN ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE GREEN TEA LEAF CHAMOMILE XANTHAN GUM CETOSTEARYL ALCOHOL LAVANDULA ANGUSTIFOLIA FLOWERING TOP HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES CALENDULA OFFICINALIS FLOWER GINKGO ASIAN GINSENG CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "079daeb4-5326-5458-e054-00144ff88e88", "id": "079ce9f7-406e-28cd-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Homosalate - 10.0% Octocrylene - 10.0% Ethyl Methoxycinnamate - 7.5 Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 2.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20151223", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Dicalcium Phosphate, FD&C Yellow #5,Lake, FD&C Yellow #6 Lake, Hydroxypropylmethylcellulose, Magensium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic cid and Titanium Dioxide." ], "purpose": [ "Purpose" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poision Control Center right away." ], "warnings": [ "Warnings Do not use for longer than one week, when abdominal pain, nausea or vomiting are present." ], "spl_product_data_elements": [ "Senna Plus Senna Plus CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM ALUMINUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CPC490" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Take preferably at bedtime or as directed by a doctor, if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable age starting dose maximum dose adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding, you fail to have a bowel movement after use of this product, may indicate a serious condition. You may report side effects to FDA at 1-800-FDA-1088." ], "storage_and_handling": [ "Store at controlled room temperature 20°C to 25°C (68°-77°F), excursions permitted to 15°C to 30°C (598°-86°F). Mfg by Contract Pharmacal Corp Hauppauge, NY 11788 USA www.CPCHealth.com" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Plus Carton Label" ], "indications_and_usage": [ "Uses For the short term relief of constipation, produce bowel movement in 6 to 12 hours." ], "set_id": "07beb7c7-af12-48a3-ae0f-fce96ce1fca8", "id": "2794d704-947c-195f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks" ], "active_ingredient": [ "Active ingredient Sennosides form Senna Concentrate 8.6mg Sodium Dioctylsulfosuccinate 50 mg" ], "dosage_and_administration_table": [ "
age starting dose maximum dose
adults and children over 12 years 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor
" ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba VE Sunscreen SPF30 Fragrance Free Homosalate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide ETHYLHEXYLGLYCERIN ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE GREEN TEA LEAF CHAMOMILE XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES GINKGO ASIAN GINSENG CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "07d72e69-4178-3268-e054-00144ff88e88", "id": "07d72e69-417a-3268-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Homosalate - 7.5% Octocrylene -7.5% Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Lavandula Angustifolia (Lavender) Extract (1), Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba Hawaiian Sunscreen Green Tea SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide ETHYLHEXYLGLYCERIN ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE GREEN TEA LEAF CHAMOMILE XANTHAN GUM CETOSTEARYL ALCOHOL LAVANDULA ANGUSTIFOLIA FLOWERING TOP HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CALENDULA OFFICINALIS FLOWER GINKGO CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "07da8cea-100a-7195-e054-00144ff8d46c", "id": "07da8cea-100b-7195-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Homosalate - 10.0% Octocrylene - 10.0% Ethyl Methoxycinnamate - 7.5 Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 2.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20110207", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "koala pals berrylicious Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID GLYCERIN HYDRATED SILICA POTASSIUM SORBATE SODIUM BENZOATE SODIUM BICARBONATE SODIUM LAUROYL SARCOSINATE SORBITOL WATER XANTHAN GUM XYLITOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal, or at least twice a day or as directed by a dentist or doctor children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years of age: ask a dentist or doctor" ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "Use aids in the prevention of cavities" ], "set_id": "0806173e-6a90-44ee-ae90-b18a021647f7", "id": "888a65ac-6a06-4065-abf3-0491e586aaf6", "active_ingredient": [ "Active ingredient Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)" ] }, { "effective_time": "20130509", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, ZINC CHLORIDE, SUCRALOSE, SODIUM BENZOATE, YELLOW 6 (CI 15985), RED 40 (CI 16035)." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-842-7886" ], "spl_product_data_elements": [ "SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID ZINC CHLORIDE SUCRALOSE SODIUM BENZOATE FD&C YELLOW NO. 6 FD&C RED NO. 40" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS." ], "set_id": "080e149c-f044-4662-81d6-d13f5132df70", "id": "72219800-a4dd-4dc7-a0ad-9ce266237e39", "active_ingredient": [ "ACTIVE INGREDIENTS EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "080f0e07-6004-40fe-868f-4e4da7fcf1f1", "id": "1fcccdd5-4dd6-43fd-a8f3-0c32bb897587", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20141118", "inactive_ingredient": [ "Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate,, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient; (2) For scent only" ], "purpose": [ "Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water." ], "spl_product_data_elements": [ "Alba Acnedote Clean Treat Towelette Salicylic Acid SODIUM CETOSTEARYL SULFATE POTASSIUM SORBATE GLYCYRRHIZA GLABRA BERGAMOT OIL SALIX ALBA BARK WATER GLYCERIN ALOE VERA LEAF ORANGE OIL PROPANEDIOL MEDIUM-CHAIN TRIGLYCERIDES C14-22 ALCOHOLS PEPPERMINT OIL HAMAMELIS VIRGINIANA TOP WATER PARSLEY CHAMOMILE MELISSA OFFICINALIS LEAF C12-20 ALKYL GLUCOSIDE CETOSTEARYL ALCOHOL ANHYDROUS CITRIC ACID SALICYLIC ACID SALICYLIC ACID POTASSIUM HYDROXIDE XANTHAN GUM BENZOIC ACID PHENOXYETHANOL SODIUM BENZOATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application." ], "package_label_principal_display_panel": [ "pouch label" ], "indications_and_usage": [ "For the treatment of acne." ], "set_id": "082758ac-3e50-11fd-e054-00144ff88e88", "id": "082758ac-3e51-11fd-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Salicylic Acid 2.0%" ] }, { "effective_time": "20110110", "inactive_ingredient": [ "Inactive Ingredients: Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carageenan, Mica, FDC Blue No.1." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Western Family Complete Whitening Sodium Fluoride Sodium Fluoride Fluoride Ion SORBITOL SILICON DIOXIDE WATER GLYCERIN SODIUM LAURYL SULFATE ZINC CITRATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM HYDROXIDE CARRAGEENAN MICA FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children Brush teeth throughly, preferably after 6 years and older each meal, or at least twice a day, or as directed by your dentist. Do not swallow. Children between To minimize swallowing, use a pea-sized 6 and 12 years amount and supervise brushing until good habits are established. Children under 6 years Ask a dentist or physician." ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "Helps protect against cavities." ], "set_id": "082d3822-cd16-4394-9aca-e4753fd8e610", "id": "e9de92b1-628f-4d40-b8f9-e4957827d8c7", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste" ] }, { "effective_time": "20141121", "inactive_ingredient": [ "Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient; (2) For scent only" ], "purpose": [ "Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water." ], "spl_product_data_elements": [ "Alba Acnedote Clean Treat Cleansing Towelette Salicylic Acid SODIUM CETOSTEARYL SULFATE POTASSIUM SORBATE GLYCYRRHIZA GLABRA BERGAMOT OIL SALIX ALBA BARK WATER GLYCERIN ALOE VERA LEAF ORANGE OIL PROPANEDIOL MEDIUM-CHAIN TRIGLYCERIDES C14-22 ALCOHOLS PEPPERMINT OIL HAMAMELIS VIRGINIANA TOP WATER PARSLEY CHAMOMILE MELISSA OFFICINALIS LEAF C12-20 ALKYL GLUCOSIDE CETOSTEARYL ALCOHOL ANHYDROUS CITRIC ACID POTASSIUM HYDROXIDE XANTHAN GUM BENZOIC ACID PHENOXYETHANOL SODIUM BENZOATE SALICYLIC ACID SALICYLIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application." ], "package_label_principal_display_panel": [ "pouch label" ], "indications_and_usage": [ "For the treatment of acne." ], "set_id": "0863929c-3a29-576c-e054-00144ff88e88", "id": "0863929c-3a2a-576c-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Salicylic Acid 2.0%" ] }, { "effective_time": "20131217", "inactive_ingredient": [ "Inactive ingredients Ginger Lime flavor, glycerin, purified water, saccharin sodium, sodium benzoate" ], "purpose": [ "Purpose Saline laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Dosage warning Taking more than the recommended dose in 24 hours can be harmful. Do not use • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities • in children under 5 years of age • for bowel cleansing Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • kidney disease • heart problems • a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than a week • a dehydration condition Ask a doctor or pharmacist before use if you are • on a sodium restricted diet • under a doctor’s care for any medical condition • taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you • have any rectal bleeding • do not have a bowel movement within 6 hours • have any symptoms that your body is losing more fluid than you are drinking • have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions 1-800-633-5463" ], "spl_product_data_elements": [ "Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate SODIUM PHOSPHATE, DIBASIC PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE" ], "ask_doctor": [ "Ask a doctor before use if you have • abdominal pain, nausea, or vomiting • kidney disease • heart problems • a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than a week • a dehydration condition" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • use as a laxative for relief of occasional constipation • dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use. • Do not use for bowel cleansing. • Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon. Ages (Years) Dosage Maximum Dose 12 & Older 3 Teaspoons 6 or 9 Teaspoons* 10 & 11 3 Teaspoons* 3 Teaspoons* 5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons* under 5 Do Not Use Do Not Use *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you • have any rectal bleeding • do not have a bowel movement within 6 hours • have any symptoms that your body is losing more fluid than you are drinking • have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting. These symptoms may indicate a serious condition." ], "storage_and_handling": [ "Other information • Each Teaspoon contains: sodium 556 mg • Saline laxatives increase retention of water in the intestine, promoting bowel movements. • this product generally produces a bowel movement in 30 minutes to 6 hours • this product is sugar free • do not freeze • store at room temperature TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use." ], "do_not_use": [ "Do not use • if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities • in children under 5 years of age • for bowel cleansing" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 0363-0126-12 Well at Walgreens SUGAR FREE SINGLE DOSE Oral Saline Laxative Phosphate • For relief of occasional constipation Sugare Free 1.5 fl oz (45 mL) GINGER LIME FLAVOR Walgreens Phosphate Oral Saline Laxative principal display panel", "Drug Facts 1 Walgreens Oral Saline Drug Facts 1", "Drug Facts 2 Walgreens Oral Saline Drug Facts 2" ], "indications_and_usage": [ "Use • for relief of occasional constipation" ], "set_id": "086fba92-75d0-4c2b-abcd-72ba10b86574", "id": "086fba92-75d0-4c2b-abcd-72ba10b86574", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • on a sodium restricted diet • under a doctor’s care for any medical condition • taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablespoon) Dibasic sodium phosphate .9 g Monobasic sodium phosphate 2.4 g" ], "dosage_and_administration_table": [ "
Ages (Years) Dosage Maximum Dose
12 & Older 3 Teaspoons 6 or 9 Teaspoons*
10 & 11 3 Teaspoons* 3 Teaspoons*
5 to 9 1 1/2 Teaspoons* 1 1/2 Teaspoons*
under 5 Do Not Use Do Not Use
" ] }, { "effective_time": "20141125", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Calendula Officinalis Flower Extract (1), Myrtus Communis Leaf Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract,Vitis Vinifera (Grape) Seed Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba VE Facial Sunscreen SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide VITIS VINIFERA SEED MYRTUS COMMUNIS LEAF ETHYLHEXYLGLYCERIN ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE GREEN TEA LEAF CHAMOMILE XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CALENDULA OFFICINALIS FLOWER GINKGO ASIAN GINSENG CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "08b403aa-fc47-2ac7-e054-00144ff8d46c", "id": "08b403aa-fc48-2ac7-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Homosalate - 7.5% Octocrylene - 7.5% Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20141125", "inactive_ingredient": [ "Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Blue 1, Red 33" ], "instructions_for_use": [ "Directions pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Antibacterial", "Uses - For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only" ], "when_using": [ "When using this product - Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Benzethonium Chloride Solution Dial Spring Water Antibacterial Hand Soap BENZETHONIUM CHLORIDE BENZETHONIUM LAURAMIDOPROPYLAMINE OXIDE LAURAMINE OXIDE PEG-120 METHYL GLUCOSE DIOLEATE GLYCERIN CETRIMONIUM CHLORIDE EDETATE SODIUM SODIUM BENZOATE D&C RED NO. 33 FD&C BLUE NO. 1 SODIUM CHLORIDE COCO MONOETHANOLAMIDE CITRIC ACID MONOHYDRATE" ], "ask_doctor": [ "Stop use and ask a doctor if irritation and redness develops" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical Liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "Visit our web site at www.dialsoap.com © 2013 THE DIAL CORPORATION, A (HENKEL) COMPANY SCOTTSDALE, AZ 85255 MADE IN USA The distinctive design and elements of this package are proprietary and owned by The Dial Corporation, A Henkel Company." ], "package_label_principal_display_panel": [ "KILLS 99.9% OF GERMS* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial® Total Clean Formula Dial Spring Water® Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) SW 32 oz SW 9.375 oz SW 5.5 oz SW 7.5 oz SW 52 oz" ], "indications_and_usage": [ "For handwashing to decrease bacteria on skin" ], "set_id": "08b5fc7a-ac58-006c-e054-00144ff8d46c", "id": "08b5fc7a-ac59-006c-e054-00144ff8d46c", "active_ingredient": [ "Benzethonium Chloride 0.10%" ] }, { "effective_time": "20111109", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis juice powder, ascorbyl palmitate, camellia sinensis leaf extract, chondurs crispus (carrageenan), commiphora myrrha oil, flavor, glycerin, hydrated sisica, melaleuca alternifolia (tea tree) leaf oil, papain, poloxamer 407, potassium acesulfame, sodium alkyl sulfate, sodium benzoate, sorbitol, tetrapotassium pyrophosphate, tetrasodium pyrphosphate, titanium dioxide, tocopheryl acetate, water, xanthan gum, xylitol, zinc citrate" ], "purpose": [ "Purpose Antisensitivity Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "precautions": [ "Other information This product contains papain, which may cause allergic reactions" ], "warnings": [ "Warnings When using this product do not use longer than four weeks unless recommended by a dentist" ], "spl_product_data_elements": [ "Sensitive Tooth Polish Potassium Nitrate and Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE POTASSIUM CATION ACESULFAME POTASSIUM ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE ASCORBYL PALMITATE CARRAGEENAN GLYCERIN GREEN TEA LEAF HYDRATED SILICA MYRRH OIL PAPAIN POLOXAMER 407 POTASSIUM PYROPHOSPHATE SODIUM BENZOATE SODIUM LAURYL SULFATE SODIUM PYROPHOSPHATE SORBITOL TEA TREE OIL TITANIUM DIOXIDE WATER XANTHAN GUM XYLITOL ZINC CITRATE Clean Mint" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or physician" ], "stop_use": [ "Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care." ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "Uses when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact aids in the prevention of cavities" ], "set_id": "08c1c9b1-ac5d-4e77-8bc3-778cb5cf3446", "id": "8b6e3ddd-a186-451d-9325-33955d161a7c", "active_ingredient": [ "Active ingredients Potassium nitrate (5.0% w/w) Sodium fluoride (0.243% w/w)" ] }, { "effective_time": "20141126", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Ananas Sativus (Pineapple) Fruit Extract (1), Carica Papaya (Papaya) Fruit Extract (1), Hibiscus Sabdariffa Flower Extract (1), Magnifera Induca (Mango) Fruit Extract (1), Passiflora Incarnata Flower Extract (1), Psidium Guajava Fruit Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organicf Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Alba HW Sunscreen Soothing Aloe Vera SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide ETHYLHEXYLGLYCERIN ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE GREEN TEA LEAF XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE TITANIUM DIOXIDE TITANIUM DIOXIDE PINEAPPLE PAPAYA HIBISCUS SABDARIFFA FLOWER MANGO PASSIFLORA INCARNATA FLOWER GUAVA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "08c86fc6-47a3-288b-e054-00144ff88e88", "id": "08c86fc6-47a4-288b-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Homosalate - 7.5% Octocrylene - 7.5% Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water." ], "purpose": [ "Purpose: Fever reducer/pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away, (1-800-222-1222). Quick 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, 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." ], "when_using": [ "When using this product do not exceed recommended dosage. (see overdose warning)" ], "questions": [ "Comments 1-888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West St. Spring Valley , NY 10977 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "spl_product_data_elements": [ "Infants Silapap Acetaminophen Acetaminophen Acetaminophen anhydrous citric acid FD&C yellow no. 6 methylparaben saccharin sodium sodium benzoate sodium citrate propylene glycol water wild cherry" ], "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 (see overdose warning) ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1.6 mL (0.8 + 0.8 mL) For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Other information Store between 20° - 25°C (68° - 77°F)" ], "stop_use": [ "Stop use and ask a doctor if ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition." ], "do_not_use": [ "Do not use with any other product containing acetaminophen (prescription or nonprescription). 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." ], "package_label_principal_display_panel": [ "Acetaminophen 80mg/0.8ml" ], "indications_and_usage": [ "Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches" ], "set_id": "0924758b-9d8c-490a-a8b3-56b5aee12962", "id": "0924758b-9d8c-490a-a8b3-56b5aee12962", "active_ingredient": [ "Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1.6 mL (0.8 + 0.8 mL)
" ] }, { "effective_time": "20120912", "inactive_ingredient": [ "INACTIVE INGREDIENTS Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax" ], "purpose": [ "PURPOSES Pain reliever/Fever reducer Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days redness or swelling is present in the painful area If pregnant or breast-feeding Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride IBUPROFEN IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GUAR GUM TRISTEARIN HYDROXYPROPYL CELLULOSE FERROSOFERRIC OXIDE KAOLIN POLYETHYLENE GLYCOLS POWDERED CELLULOSE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX 423 Caplets" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days redness or swelling is present in the painful area" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25 ○ C (68 - 77 ○ F). Avoid excessive heat above 40 ○ C (104 ○ F). read all warnings and directions before use. Keep carton. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to 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 right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL QC QUALITY CHOICE ® NDC 63868-453-20 * Compare to the active ingredients in Advil ® Cold & Sinus NON-DROWSY IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP Cold & Sinus Formula Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID) ٭ Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant FOR RELIEF OF: Sinus Pressure Nasal Congestion Fever 20 COATED CAPLETS † ( † Oval-Shaped Tablets) ٭ nonsteroidal anti-inflammatory drug © DISTRIBUTED BY QUALITY CHOICE 5089124/R0811 This is the 20 count blister carton label for Quality Choice Ibuprofen and Pseudoephedrine HCl Tablets, USP." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms associated with the common cold or flu: fever sinus pressure nasal congestion headache minor body aches and pains" ], "set_id": "093e6388-54f2-4d04-ba55-8f7c9c182a0e", "id": "9b971e5f-98b5-4030-96d0-2b8aa5c03609", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH CAPLET) Ibuprofen, USP 200 mg (NSAID) * Pseudoephedrine HCl, USP 30 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141210", "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Yellow 5, Red 4" ], "instructions_for_use": [ "Directions pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Purpose Antibacterial", "Uses For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Dial Antibacterial Hand Wash Dial Gold Antibacterial Hand Soap SODIUM CHLORIDE FD&C YELLOW NO. 5 Benzethonium Chloride Benzethonium LAURAMINE OXIDE COCO MONOETHANOLAMIDE PEG-120 METHYL GLUCOSE DIOLEATE GLYCERIN EDETATE SODIUM SODIUM BENZOATE CITRIC ACID MONOHYDRATE FD&C RED NO. 4 CETRIMONIUM CHLORIDE LAURAMIDOPROPYLAMINE OXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical Liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "Visit our website at www.dialsoap.com MADE IN USA ©2014 & Distributed by THE DIAL CORPORATION a Henkel COMPANY SCOTTSDALE, AZ 85255 The distinctive design and elements of this package are propriatary and owned by The Dial Corporation, A Henkel Company" ], "stop_use": [ "Stop use and ask a doctor Stop use and ask a doctor if irritation and redness develops" ], "package_label_principal_display_panel": [ "Kills 99.9% of Germs* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial© Total Clean Formula DIAL Gold Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) 7.5 oz size 5.5 oz size 9.375 oz size 32 oz size 52 oz size 128 oz size" ], "indications_and_usage": [ "For handwashing to decrease bacteria on the skin" ], "set_id": "09dfccfb-74da-7180-e054-00144ff8d46c", "id": "09dfccfb-74db-7180-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Benzethonium Chloride 0.1%" ] }, { "effective_time": "20141216", "inactive_ingredient": [ "Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Yellow 6, Red 40" ], "instructions_for_use": [ "pump into hands, wet as needed later vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Antibacterial", "Uses - For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "For external use only" ], "when_using": [ "When using this product - Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Dial Antibacterial Hand Wash Dial Pomegranite and Tangerine Antibacterial Hand Soap with Moisturizer COCO MONOETHANOLAMIDE Lauramine Oxide Benzethonium Chloride Benzethonium GLYCERIN CETRIMONIUM CHLORIDE D&C RED NO. 33 Sodium Chloride Lauramidopropylamine Oxide PEG-120 Methyl Glucose Dioleate EDETATE SODIUM Sodium Benzoate CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 FD&C RED NO. 40" ], "ask_doctor": [ "Stop use and ask doctor if irritation and redness develops" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "Visit our website at www.dialsoap.com MADE IN USA ©2014 & Distributed by THE DIAL CORPORATION a Henkel COMPANY SCOTTSDALE, AZ 85255 The distinctive design and elements of this package are propriatary and owned by The Dial Corporation, A Henkel Company" ], "package_label_principal_display_panel": [ "Front label Kills 99.9% of Germs* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial© Total Clean Formula DIAL Pomegranite and Tangerine Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) 9.375 oz size 7.5 oz size 32 oz size 52 oz size 128 oz size" ], "indications_and_usage": [ "For handwashing to decrease bacteria on skin" ], "set_id": "0a5bd1ce-bc9d-5490-e054-00144ff88e88", "id": "0a5bd1ce-bc9e-5490-e054-00144ff88e88", "active_ingredient": [ "Benzethonium Chloride 0.10%" ] }, { "effective_time": "20141216", "inactive_ingredient": [ "Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, Camellia Sinensis (White Tea) Leaf Extract, Tocopheryl Acetate, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Blue 1, Red 33" ], "instructions_for_use": [ "Directions pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Antibacterial", "Uses - For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product - Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Dial Antibacterial Hand Wash Dial White Tea and Vitamin E Antibacterial Hand soap with Moisturizer EDETATE SODIUM Citric Acid Monohydrate D&C RED NO. 33 Sodium Chloride CETRIMONIUM CHLORIDE Sodium Benzoate FD&C BLUE NO. 1 .ALPHA.-TOCOPHEROL ACETATE GREEN TEA LEAF GLYCERIN Benzethonium Chloride Benzethonium Lauramine Oxide Lauramidopropylamine Oxide COCO MONOETHANOLAMIDE PEG-120 Methyl Glucose Dioleate" ], "ask_doctor": [ "Stop use and ask a doctor if irritation and redness develops" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical Liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "Visit our website at www.dialsoap.com MADE IN USA ©2014 & Distributed by THE DIAL CORPORATION a Henkel COMPANY SCOTTSDALE, AZ 85255 The distinctive design and elements of this package are propriatary and owned by The dial Corporation, A Henkel Company" ], "package_label_principal_display_panel": [ "Kills 99.9% of Germs* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial© Total Clean Formula DIAL White Tea and Vitamin E Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) 7.5 oz size", "9.375 oz size", "52 oz size" ], "indications_and_usage": [ "For handwashing to decrease bacteria on the skin" ], "set_id": "0a5e322f-6740-28be-e054-00144ff88e88", "id": "0a5e322f-6741-28be-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Benzethonium Chloride 0.10%" ] }, { "effective_time": "20141217", "inactive_ingredient": [ "Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, Glycol Distearate, Steareth-4, Aloe Barbadensis Leaf Juice, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Yellow 5, Blue 1" ], "instructions_for_use": [ "Directions Pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Antibacterial", "Uses - For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only" ], "when_using": [ "When using this product - Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Benzethonium Chloride Solution Dial Aloe Antibacterial Hand Soap with Moisturizer PEG-120 METHYL GLUCOSE DIOLEATE EDETATE SODIUM COCO MONOETHANOLAMIDE CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 5 FD&C BLUE NO. 1 SODIUM CHLORIDE ALOE VERA LEAF GLYCOL DISTEARATE STEARETH-4 LAURAMINE OXIDE GLYCERIN CETRIMONIUM CHLORIDE SODIUM BENZOATE BENZETHONIUM CHLORIDE BENZETHONIUM LAURAMIDOPROPYLAMINE OXIDE" ], "ask_doctor": [ "Stop use and ask a doctor if irritation and redness develops" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "Visit our web site at www.dialsoap.com © 2014 Distributed by THE DIAL CORPORATION, A (HENKEL) COMPANY SCOTTSDALE, AZ 85255 MADE IN USA The distinctive design elements of this package are proprietary and owned by The Dial Corporation, a Henkel Company" ], "package_label_principal_display_panel": [ "KILLS 99.9% OF GERMS* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial® Total Clean Formula Dial Aloe Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) Aloe 9.375 oz Aloe 7.5 oz" ], "indications_and_usage": [ "For handwashing to decrease bacteria on skin" ], "set_id": "0a6c9eee-ddbf-5cf5-e054-00144ff8d46c", "id": "0a6c9eee-ddc0-5cf5-e054-00144ff8d46c", "active_ingredient": [ "Benzethonium Chloride 0.10%" ] }, { "effective_time": "20150917", "inactive_ingredient": [ "Inactive ingredients AQUA/WATER - GLYCERIN - OCTY;DODECYL MYRISTATE - PENTYLENE GLYCOL - DIMETHICONE - POLY-METHYL METHACRYLATE - COCO-CAPRYLATE/CAPR-ATE - CETEARYL ALCOHOL - CYCLOMETHICONE - GLYCERYL STEARATE - PEG-100 STEARATE - CETYL PALMITATE - PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL - PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT - PRUNUS AMY-GDALUS DULCIS (SWEET ALMOND) LEAF CELL EXTRACT - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - CETYL ALCOHOL - CETEARETH-33 - SODIUM BENZOATE - DIMETHICONOL - XANTHAN GUM - TOCOPHEROL - DISODIUM EDTA - SORBITAN ISOSTEARATE - POLY-SORBATE 60 - 1,2-HEXANEDIOL - CAPRYLYL GLYCOL - PARFUM/FRAGRANCE - BENZYL SALICYLATE - LINALOOL - CITRONELLOL - GERANIOL - LIMONENE." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings ​For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? Call toll free 1 888 623 2880" ], "spl_product_data_elements": [ "L Occitane Youthful Hand with Almond Tree Native Cells Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE WATER GLYCERIN OCTYLDODECYL MYRISTATE PENTYLENE GLYCOL DIMETHICONE METHYL METHACRYLATE CETOSTEARYL ALCOHOL CYCLOMETHICONE GLYCERYL MONOSTEARATE PEG-100 STEARATE CETYL PALMITATE ALMOND OIL ALMOND SUNFLOWER OIL CETYL ALCOHOL CETEARETH-33 SODIUM BENZOATE XANTHAN GUM TOCOPHEROL EDETATE DISODIUM SORBITAN ISOSTEARATE POLYSORBATE 60 1,2-HEXANEDIOL CAPRYLYL GLYCOL BENZYL SALICYLATE LINALOOL, (+/-)- .BETA.-CITRONELLOL, (R)- GERANIOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating ​Sun Protection Measures. ​spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, espeially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Other Information Protect the product in this container from excessive heat and direct sun." ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "Product Label Tube Carton" ], "indications_and_usage": [ "Uses helps prevent sunburn if used as directed with other sun protection measures (see ​Directions ​), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0a77da4a-f283-468c-8097-efec9dd809b7", "id": "088e9c8d-9f0a-4897-aae2-ea870201d2cb", "active_ingredient": [ "Active Ingredients Butyl Methoxydibenzoylmethane / Avobenzone 3% Homosalate 5% Ethylhexyl Methoxycinnamate / Octinoxate 7.5% Ethylhexyl Salicylate / Octisalate 5%" ] }, { "effective_time": "20150108", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Euterpe Olearacea Fruit Extract, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Citric Acid, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Jason Sun Sport Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide ACAI CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "0af9fecf-1dca-4944-e054-00144ff88e88", "id": "0c2b8c34-67b7-3ae9-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Homosalate - 10.0% Octocrylene - 7.0% Ethyl Methoxycinnamate - 7.5 Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20111102", "inactive_ingredient": [ "Inactive Ingredients: Calcium Carbonate, Water, Sorbitol, Sodium Lauryl Sulfate, Silica, Carboxymethyl Cellulose, Flavor, Potassium Nitrate, Sodium benzoate, Sodium saccharin, menthol" ], "purpose": [ "Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "If more than is used for brushing is accidentally swallowed, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "MEDICHOICE ANTICAVITY FLUORIDE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SODIUM LAURYL SULFATE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE POTASSIUM NITRATE SODIUM BENZOATE SACCHARIN SODIUM MENTHOL" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions: Adults and children 2 yrs and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 yrs: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician. If more than is used for brushing is accidentally swallowed, seek professional help or contact a Poison Control Center immediately. Keep out of reach of children." ], "spl_unclassified_section": [ "Expiration Date: Expiration Date and Batch No. on crimp of Tube", "E.c No.: DD/COS/DD/C/52 Made in India MediChoice Reorder: 2002PC7385 Distributed by: Owens and Minor Mechanicsville, VA 23116 804.723.7000" ], "package_label_principal_display_panel": [ "tube", "MEDICHOICE Reorder: 2002PC7385 Anticavity Fluoride Toothpast 0.85 oz Contents: 144/bx Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "box", "Medichoice Reorder: 2002PC7385 Anticavity Fluoride Toothpaste 0.85 oz Contents: 144/bx, 5 boxes/cs, 720 cs Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "case" ], "indications_and_usage": [ "Use: Aids in the prevention of dental cavities." ], "set_id": "0b5a2788-ae38-44ca-bfc8-fb3c74ea95c9", "id": "fd3f54a2-301d-4b04-ae8c-13dc9b212848", "active_ingredient": [ "DRUG FACTS Active Ingredient: Purpose Sodium Fluoride 0.22% Anticavity Anticavity" ] }, { "effective_time": "20150107", "inactive_ingredient": [ "Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Blue 1, Red 33" ], "instructions_for_use": [ "Directions pump into hands, wet as needed lather vigorously for at least 15 seconds wash skin, rinse thoroughly and dry" ], "purpose": [ "Antibacterial", "Uses - For handwashing to decrease bacteria on the skin" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only" ], "when_using": [ "When using this product - Avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL (3425)" ], "spl_product_data_elements": [ "Benzethonium Chloride Solution Dial Lavender and Twilight Jasmine Antibacterial Hand Soap with Moisturizer D&C RED NO. 33 BENZETHONIUM CHLORIDE BENZETHONIUM LAURAMINE OXIDE LAURAMIDOPROPYLAMINE OXIDE COCO MONOETHANOLAMIDE PEG-120 METHYL GLUCOSE DIOLEATE GLYCERIN CETRIMONIUM CHLORIDE EDETATE SODIUM SODIUM BENZOATE CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1" ], "ask_doctor": [ "Stop use and ask a doctor if irritation and redness develops." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Topical liquid" ], "spl_unclassified_section": [ "Drug Facts", "* Encountered in household settings", "© 2014 & Distributed by THE DIAL CORPORATION a Henkel COMPANY SCOTTSDALE, AZ 85255 Made in USA The distinctive design and elements of this package are proprietary and owned by The Dial Corporation, A Henkel Company Patent Pending" ], "package_label_principal_display_panel": [ "KILLS 99.9% OF GERMS* New Active! TOTAL CLEAN FORMULA Refill ONLY with Dial® Total Clean Formula Dial Lavender and Twilight Jasmine Hand Soap with Moisturizer Antibacterial 7.5 FL OZ (221 mL) LTJ 9.375 oz LTJ 7.5 oz" ], "indications_and_usage": [ "For handwashing to decrease bacteria on skin" ], "set_id": "0c182e6c-dd05-09b7-e054-00144ff88e88", "id": "0c182e6c-dd06-09b7-e054-00144ff88e88", "active_ingredient": [ "Benzethonium Chloride 0.10%" ] }, { "effective_time": "20140423", "inactive_ingredient": [ "Inactive Ingredients Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose." ], "purpose": [ "Active Ingredients (in each 5 mL, teaspoonful) Purpose Guaifenesin 50 mg Expectorant Dextromethorphan HBr 5 mg Cough Suppressant Pseudoephedrine HCI 15 mg Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children ." ], "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. Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. A persistent cough may be the 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 asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately . Keep this and all drugs out of the reach of children ." ], "spl_product_data_elements": [ "G-Tuss-NL Ped Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Sucralose Propylene Glycol Water" ], "ask_doctor": [ "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 the 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." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not take more than 6 doses in any 24-hour period. Children 6 to under 12 years of age 2 teaspoonfuls (10 mL) every 4 hours Children 2 to under 6 years of age 1 teaspoonful (5 mL) every 4 hours Children under 2 years of age Consult a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other Information Store at 20°-25°C (68°-77°F) Tamper evident by seal under cap. Do not use if the seal is broken or missing." ], "do_not_use": [ "Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.", "Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor." ], "active_ingredient_table": [ "
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Guaifenesin 50 mg Expectorant
Dextromethorphan HBr 5 mg Cough Suppressant
Pseudoephedrine HCI 15 mg Nasal Decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC-43913-406-16 G-Tuss-NL Ped Cough Suppressant, Expectorant & Nasal Decongestant Sugar Free • Dye Free • Alcohol Free • Phenylalanine Free Grape Flavor 16 FL OZ (473 mL) Multiple Dose Unit Package For Dispensing Under Pharmaceutical Supervision Only McLaren Medical Principal Display Panel - 473 mL Bottle Label" ], "indications_and_usage": [ "Indications For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis). Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Temporarily helps you cough less." ], "set_id": "0c2632f4-edbc-47d4-94ef-af3512520596", "id": "bdcee84a-2613-400a-a813-8ba860ed66c0", "purpose_table": [ "
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Guaifenesin 50 mg Expectorant
Dextromethorphan HBr 5 mg Cough Suppressant
Pseudoephedrine HCI 15 mg Nasal Decongestant
" ], "ask_doctor_or_pharmacist": [ "In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately ." ], "active_ingredient": [ "Active Ingredients (in each 5 mL, teaspoonful) Purpose Guaifenesin 50 mg Expectorant Dextromethorphan HBr 5 mg Cough Suppressant Pseudoephedrine HCI 15 mg Nasal Decongestant" ], "dosage_and_administration_table": [ "
Children 6 to under 12 years of age 2 teaspoonfuls (10 mL) every 4 hours
Children 2 to under 6 years of age 1 teaspoonful (5 mL) every 4 hours
Children under 2 years of age Consult a doctor
" ] }, { "effective_time": "20150108", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Extract (1), Chamomilla Recutita (Matricaria) Flower Extract(1), Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Jason Sun Kids Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide CALENDULA OFFICINALIS FLOWER CHAMOMILE ETHYLHEXYLGLYCERIN BENZYL ALCOHOL PHENOXYETHANOL ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ALCOHOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "0c2dc068-ad7d-6a28-e054-00144ff88e88", "id": "0c2dc068-ad7e-6a28-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Homosalate - 10.0% Octocrylene - 7.0% Ethyl Methoxycinnamate - 7.5 Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20150812", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Citric Acid, Demineralized Water, Ethanol 2.1%, Sodium Benzoate." ], "purpose": [ "INDICATIONS: For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN: KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS: If symptoms persist or worsen, seek the advice of a healthcare professional. Caution: Not recommended for pregnant or lactating women. KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away. Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken." ], "questions": [ "QUESTIONS: Manufactured for 21st Century Homeopathics Rosenberg, TX 77471 (281) 344-0909 A subsidiary of Biotics Research Corporation" ], "spl_product_data_elements": [ "1 Detoxification Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium, CAPSICUM CAPSICUM PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT TRIFOLIUM PRATENSE FLOWER TRIFOLIUM PRATENSE FLOWER ALUMINUM ALUMINUM ANTIMONY TRISULFIDE ANTIMONY TRISULFIDE SILVER SILVER ARSENIC TRIOXIDE ARSENIC CATION (3+) GOLD GOLD BARIUM CARBONATE BARIUM CATION BERYLLIUM BERYLLIUM BISMUTH BISMUTH BORON BORON CADMIUM CADMIUM CERIUM CERIUM CESIUM CHLORIDE CESIUM CATION CHROMIUM CHROMIUM COBALT COBALT COPPER COPPER DYSPROSIUM DYSPROSIUM ERBIUM ERBIUM EUROPIUM OXIDE EUROPIUM OXIDE IRON IRON GADOLINIUM OXIDE GADOLINIUM CATION (3+) GERMANIUM SESQUIOXIDE GERMANIUM SESQUIOXIDE HOLMIUM HOLMIUM INDIUM INDIUM LANTHANUM OXIDE LANTHANUM OXIDE LITHIUM CARBONATE LITHIUM CATION MAGNESIUM MAGNESIUM MANGANESE MANGANESE MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS MOLYBDENUM MOLYBDENUM NEODYMIUM OXIDE NEODYMIUM OXIDE NICKEL NICKEL NIOBIUM NIOBIUM OSMIUM OSMIUM PALLADIUM PALLADIUM PLATINUM PLATINUM LEAD LEAD PRASEODYMIUM PRASEODYMIUM RHODIUM RHODIUM RUBIDIUM RUBIDIUM SAMARIUM OXIDE SAMARIUM OXIDE SELENIUM SELENIUM TIN TIN STRONTIUM CARBONATE STRONTIUM CATION TANTALUM TANTALUM TERBIUM TERBIUM THALLIUM THALLIUM URANYL NITRATE HEXAHYDRATE URANIUM CATION (6+) VANADIUM VANADIUM YTTERBIUM OXIDE YTTERBIUM OXIDE ZINC ZINC CORTICOTROPIN CORTICOTROPIN BACILLUS ANTHRACIS IMMUNOSERUM RABBIT BACILLUS ANTHRACIS IMMUNOSERUM RABBIT SUS SCROFA PITUITARY GLAND SUS SCROFA PITUITARY GLAND ANGUILLA ROSTRATA BLOOD SERUM ANGUILLA ROSTRATA BLOOD SERUM TARTARIC ACID TARTARIC ACID THERIDION CURASSAVICUM THERIDION CURASSAVICUM SUS SCROFA THYROID SUS SCROFA THYROID APIS MELLIFERA APIS MELLIFERA BROMINE BROMINE OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE CARBO ANIMALIS CARBO ANIMALIS ACTIVATED CHARCOAL ACTIVATED CHARCOAL HUMAN BREAST TUMOR CELL HUMAN BREAST TUMOR CELL CONIUM MACULATUM FLOWERING TOP CONIUM MACULATUM FLOWERING TOP GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT POTASSIUM DICHROMATE DICHROMATE ION LACHESIS MUTA VENOM LACHESIS MUTA VENOM SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION PHOSPHORIC ACID PHOSPHORIC ACID PHOSPHORUS PHOSPHORUS RANCID BEEF RANCID BEEF CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM STRYCHNOS WALLICHIANA BARK STRYCHNOS WALLICHIANA BARK SULFURIC ACID SULFURIC ACID ALLYLTHIOUREA ALLYLTHIOUREA THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT ALCOHOL, X-RAY EXPOSED (1000 RAD) ALCOHOL, X-RAY EXPOSED (1000 RAD) CITRIC ACID MONOHYDRATE SODIUM BENZOATE WATER ALCOHOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS: One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age." ], "package_label_principal_display_panel": [ "PACKAGE LABEL DISPLAY: 21ST CENTURY HOMEOPATHICS NDC #63972-001-01 HOMEOPATHIC REMEDY #1 Detoxification Water Based Formula (2.1% Ethanol) 4 fl. oz. (120 ml) #1 Detoxification" ], "indications_and_usage": [ "INDICATIONS: For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair." ], "set_id": "0c3ba835-db6a-472a-b93a-c155fe0a9c05", "id": "6fc5032b-1141-4d1b-aae6-29fb55cffd69", "active_ingredient": [ "ACTIVE INGREDIENTS: CAPSICUM ANNUUM 3X, 30C, PHYTOLACCA DECANDRA 3X, 30C, TRIFOLIUM PRATENSE 3X, 30X, ALUMINUM METALLICUM 12X, 30X, ANTIMONIUM CRUDUM 12X, 30X, ARGENTUM METALLICUM 12X, 30X, ARSENICUM ALBUM 12X, 30X, AURUM METALLICUM 12X, 30X, BARYTA CARBONICA 12X, 30X, BERYLLIUM METALLICUM 12X, 30X, BISMUTHUM METALLICUM 12X, 30X, BORON 12X, 30X, BROMIUM 12X, 30X, CADMIUM METALLICUM 12X, 30X, CERIUM METALLICUM 12X, 30X, CESIUM CHLORIDE 12X, 30X, CHROMIUM METALLICUM 12X, 30X, COBALTUM METALLICUM 12X, 30X, CUPRUM METALLICUM 12X, 30X, DYSPROSIUM METALLICUM 12X, 30X, ERBIUM METALLICUM 12X, 30X, EUROPIUM OXYDATUM 12X, 30X, FERRUM METALLICUM 12X, 30X, GADOLINIUM OXYDATUM 12X, 30X, GERMANIUM SESQUIOXIDE 12X, 30X, HOLMIUM 12X, 30X, INDIUM METALLICUM 12X, 30X, LANTHANUM OXYDATUM 12X, 30X, LITHIUM CARBONICUM 12X, 30X, MAGNESIUM METALLICUM 12X, 30X, MANGANUM METALLICUM 12X, 30X, MERCURIUS SOLUBILIS 12X, 30X, MOLYBDENUM METALLICUM 12X, 30X, NEODYMIUM OXYDATUM 12X, 30X, NICCOLUM METALLICUM 12X, 30X, NIOBIUM 12X, 30X, OSMIUM METALLICUM 12X, 30X, PALLADIUM METALLICUM 12X, 30X, PLATINUM METALLICUM 12X, 30X, PLUMBUM METALLICUM 12X, 30X, PRASEODYMIUM 12X, 30X, RHODIUM METALLICUM 12X, 30X, RUBIDIUM METALLICUM 12X, 30X, SAMARIUM OXYDATUM 12X, 30X, SELENIUM METALLICUM 12X, 30X, STANNUM METALLICUM 12X, 30X, STRONTIUM CARBONICUM 12X, 30X, TANTALUM 12X, 30X, TERBIUM 12X, 30X, THALLIUM METALLICUM 12X, 30X, URANIUM NITRICUM 12X, 30X, VANADIUM METALLICUM 12X, 30X, YTTERBIUM OXYDATUM 12X, 30X, ZINCUM METALLICUM 12X, 30X, ADRENOCORTICOTROPHIN 30X, ANTHRACINUM 30X, PITUITARIA GLANDULA (SUIS) 30X, SERUM ANGUILLAE 30X, TARTARICUM ACIDUM 30X, THERIDION 30X, THYROIDINUM (SUIS) 30X, APIS MELLIFICA 30C, BROMIUM 30C, CALCAREA CARBONICA 30C, CARBO ANIMALIS 30C, CARBO VEGETABILIS 30C, CARCINOSIN 30C, CONIUM MACULATUM 30C, GELSEMIUM SEMPERVIRENS 30C, KALI BICHROMICUM 30C, LACHESIS MUTUS 30C, NATRUM PHOSPHORICUM 30C, PHOSPHORICUM ACIDUM 30C, PHOSPHORUS 30C, PYROGENIUM 30C, SECALE CORNUTUM 30C, HOANG-NAN 30C, SULPHURICUM ACIDUM 30C, THIOSINAMINUM 30C, THUJA OCCIDENTALIS 30C, VERATRUM ALBUM 30C, X-RAY 30C." ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1),Cucumis Sativus (Cucumber) Fruit Extract, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Citric Acid, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Jason Sun Family Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide CITRIC ACID MONOHYDRATE GREEN TEA LEAF CUCUMBER ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE XANTHAN GUM CETOSTEARYL ALCOHOL HYDROGENATED PALM KERNEL OIL LECITHIN, SOYBEAN POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE ALCOHOL HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ETHYLHEXYLGLYCERIN BENZYL ALCOHOL PHENOXYETHANOL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours." ], "package_label_principal_display_panel": [ "tube label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "0c3e0fd3-adc6-5ad1-e054-00144ff8d46c", "id": "0c3e0fd3-adc7-5ad1-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredient Homosalate - 10.0% Octocrylene - 7.0% Ethyl Methoxycinnamate - 7.5 Ethylhexyl Salicylate - 5.0% Butyl Methoxydibenzoylmethane - 3.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20130513", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), GREEN 3 (CI 42053)." ], "purpose": [ "PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "warnings": [ "WARNINGS DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)." ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-842-7886" ], "spl_product_data_elements": [ "SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE D&C YELLOW NO. 10 FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW." ], "storage_and_handling": [ "OTHER INFORMATION STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP REDUCE AND PREVENT PLAQUE AND GINGIVITIS." ], "set_id": "0c3ee0f2-6637-42fd-9f72-01ec4de3c7ba", "id": "949dd636-d8ba-4a5b-ae1e-3ccec300cd7b", "active_ingredient": [ "ACTIVE INGREDIENT EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064% PURPOSE ANTIPLAQUE/ANTIGINGIVITIS" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1) Vitis Vinifera (Grape) Seed Extract, Cetearyl Olivate, Polysorbate 60, Benzoic Acid, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Citric Acid ,Dehydroacetic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate. (1) Certified Organic Ingredient" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact Poison Center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "spl_product_data_elements": [ "Jason Sun Facial Sunscreen Broad Spectrum SPF20 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide CITRIC ACID MONOHYDRATE GREEN TEA LEAF ALOE VERA LEAF GLYCERIN WATER VINYLPYRROLIDONE/HEXADECENE COPOLYMER SODIUM STEAROYL GLUTAMATE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL STEARATE SE POTASSIUM SORBATE CETYL ALCOHOL DIMETHICONE XANTHAN GUM CETOSTEARYL ALCOHOL DEHYDROACETIC ACID POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE SILICON DIOXIDE SODIUM CHLORIDE SORBITAN OLIVATE SODIUM BENZOATE ALCOHOL PHENOXYETHANOL HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE TITANIUM DIOXIDE TITANIUM DIOXIDE VITIS VINIFERA SEED BENZOIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours." ], "package_label_principal_display_panel": [ "bottle label" ], "indications_and_usage": [ "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases." ], "set_id": "0c410785-787b-15ef-e054-00144ff88e88", "id": "0c410785-787c-15ef-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient Homosalate -7.5% Octocrylene - 5.0% Ethylhexyl Salicylate - 3.0% Butyl Methoxydibenzoylmethane - 2.0% Titanium Dioxide - 1.0%" ] }, { "effective_time": "20140314", "inactive_ingredient": [ "Inactive ingredients Water, Alcohol 21.6%, Sorbitol Solution, Poloxamer 407, Benzoic Acid, Sodium Benzoate ,Flavour, Sodium Saccharin & FD&C Orange No.5" ], "purpose": [ "Purpose Antiplaque/Antigingivitis" ], "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 swallow Not to be used by children under 12 years of age" ], "spl_product_data_elements": [ "Buenos Dias de Personna citrus flavour Eucalyptol , Menthol , Methyl Salicylate, Thymol EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SODIUM BENZOATE SACCHARIN SODIUM SODIUM CITRATE CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 FD&C RED NO. 40" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis." ], "spl_unclassified_section": [ "Other information Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (59 0 -86 0 F). Do not use if security band around cap is missing or broken.", "Distributed By 2011 Energiser Personal Care LL dba Personna International of PR #36 Carr 20 Kim 2.2 Suite 203, Guaynabo PR00966 787-761-9500 Made in Trinidad & Tobago,W.I." ], "package_label_principal_display_panel": [ "Packaging Personna citrus" ], "indications_and_usage": [ "Uses Helps kill germs that cause plaque, gingivitis and bad breath." ], "set_id": "0c6482ef-55e1-4443-9cd2-d756d058f242", "id": "68679312-84e8-4e5d-aaca-13625ba89e1d", "active_ingredient": [ "Active ingredients (W/V) Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%" ] }, { "effective_time": "20150807", "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 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information safety sealed: do not use if imprinted safety seal is torn or missing store between 20° and 25°C (68° and 77°F)" ], "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": "0cd1a8be-4184-4534-99f9-0fcc0dcc5224", "id": "42c6a214-9cc6-4939-806c-42d8d33cfdcc", "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder." ], "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": [ "sunmark Childrens Loratadine Loratadine Loratadine Loratadine glycerin sorbitol phosphoric acid polyethylene glycols propylene glycol water sodium benzoate sodium metabisulfite sodium phosphate, monobasic, dihydrate colorless to slightly yellow sugar free" ], "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 use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by McKesson One Post Street, San Francisco, CA 94104" ], "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 - 120 mL Bottle Carton sunmark ® COMPARE TO CHILDREN'S CLARITIN ® ACTIVE INGREDIENT* NDC 49348-333-34 24 HOUR ALLERGY RELIEF children's loratadine syrup (Loratadine Oral Solution) 5 mg/5 mL Antihistamine Relief of sneezing, runny nose itchy, watery eyes itchy throat or nose Dye Free Non-drowsy† Ages two years & older SUGAR FREE GRAPE FLAVOR 4 FL OZ (120 mL) †When taken as directed. See Drug Facts Panel. Principal Display Panel - 120 mL Bottle Carton" ] }, { "effective_time": "20150116", "purpose": [ "Purpose Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product • avoid alcoholic beverages and other drugs that cause drowsiness • drowsiness will occur • be careful when driving a motor vehicle or operating machinery" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information • each 30 mL dose (2 tablespoons) contains: sodium 23 mg • store at room temperature • protect from light. Does not meet USP <671>." ], "indications_and_usage": [ "Uses • for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep" ], "set_id": "0d1771df-d51c-4da6-b8ca-f8aacce5b9df", "id": "0d1771df-d51c-4da6-b8ca-f8aacce5b9df", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid" ], "active_ingredient": [ "Active ingredient (in each 30 mL dose cup or 2 tablespoons) Diphenhydramine HCl 50 mg" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum." ], "warnings": [ "Warnings Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have • a breathing problem such as asthma, emphysema, or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland • heart disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid When using this product • avoid alcoholic beverages and other drugs that cause drowsiness • drowsiness will occur • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "up and up nighttime sleep-aid DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POTASSIUM CITRATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have • a breathing problem such as asthma, emphysema, or chronic bronchitis • glaucoma • difficulty in urination due to enlargement of the prostate gland • heart disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • take only one dose per day (24 hours) – see Overdose warning • use dose cup or tablespoon adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor" ], "spl_unclassified_section": [ "Drug Facts", "" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness." ], "do_not_use": [ "Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 11673-730-92 Compare to active ingredient in ZzzQuil™* nighttime sleep-aid diphenhydramine HCl non-habit forming alcohol free BERRY FLAVOR SEE WARNINGS NOT FOR TREATING COLD OR FLU 12 FL OZ (354 mL) Failure to follow these warnings could result in serious consequences. TAMPER EVIDENT: Do not use if printed shrink band is missing or broken *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil® Questions? Call 1-800-910-6874 094 01 0778 R00 ID274446 Distributed by Target Corporation Minneapolis, MN 55403 ©2014 Target Brands, Inc. Shop Target.com up and up nighttime sleep aid Berry Flavor" ] }, { "effective_time": "20120529", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, FRAGRANCE (PARFUM), CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM XYLENESULFONATE." ], "purpose": [ "PURPOSE ANTIDANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS? 1-888-723-3929" ], "spl_product_data_elements": [ "SAFEWAY DANDRUFF DRY SCALP PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE DIMETHICONE CETYL ALCOHOL POLYQUATERNIUM-10 (400 CPS AT 2%) MAGNESIUM SULFATE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE AMMONIUM LAURETH-3 SULFATE BENZYL ALCOHOL SODIUM CHLORIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM XYLENESULFONATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF." ], "set_id": "0d2241dd-79a6-48cb-9e8e-b28a23b38139", "id": "db7d8507-aa48-4ba5-b14a-a907b07c71bc", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTIDANDRUFF" ] }, { "effective_time": "20121220", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl glucoside, Isostearyl isostearate, Tribehenin, Butyrospermum parkii (Shea) butter, Propylene glycol, Cetearyl alcohol, Sodium polyacrylate, Potassium cetyl phosphate, Phenoxyethanol, Dimethicone crosspolymer, Caprylyl glycol, Parfum (Fragrance), Citric acid, Dipropylene glycol, Sodium benzoate, Acrylates/vinyl isodecanoate crosspolymer, Ethylhexylglycerin, Potassium sorbate, Tetrasodium EDTA, Sorbitol, Tilia cordata flower extract, Althaea officinalis root extract, Tocopheryl acetate, Silica" ], "purpose": [ "Uses Uses - helps prevent sunburn." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away." ], "spl_product_data_elements": [ "Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER GLYCERIN DIMETHICONE CETEARYL GLUCOSIDE ISOSTEARYL ISOSTEARATE TRIBEHENIN SHEA BUTTER PROPYLENE GLYCOL CETOSTEARYL ALCOHOL SODIUM POLYACRYLATE (8000 MW) POTASSIUM CETYL PHOSPHATE PHENOXYETHANOL CAPRYLYL GLYCOL CITRIC ACID MONOHYDRATE DIPROPYLENE GLYCOL SODIUM BENZOATE ETHYLHEXYLGLYCERIN POTASSIUM SORBATE EDETATE SODIUM SORBITOL TILIA CORDATA FLOWER ALTHAEA OFFICINALIS ROOT .ALPHA.-TOCOPHEROL ACETATE SILICON DIOXIDE" ], "description": [ "Description Immediately calms sensitive skin and with continued use reduces skin reactivity. Active plant extract, Marshmallow, contains natural sugars and polyphenols to help calm skin and leave it less sensitive. Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.", "Description Directions: Use every morning after cleansing" ], "warnings_and_cautions": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove", "Warnings Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately." ], "ask_doctor": [ "Ask a doctor Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "2", "storage_and_handling": [ "Storage Other information - protect the product in this container from excessive heat and direct sun" ], "information_for_patients": [ "Information Made in the UK. The Boots Company PLC Nottingham England NG2 3AA Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA www.boots.com", "Information The Boots Company PLC Notingham England NG2 3AA Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA Made in the UK www.boots.com" ], "package_label_principal_display_panel": [ "Carton Carton label Carton" ], "indications_and_usage": [ "Directions Directions for sunscreen use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "set_id": "0d4986d4-a429-4a97-9d23-6a903e167cda", "id": "cd9a29cc-a2d2-4eed-8da7-952777c2e94a", "active_ingredient": [ "Carton Active Ingredients Section Active Ingredients Avobenzone 3% Octisalate 3% Octocrylene 5% Purpose Sunscreen", "Jar label Boots Botanics The Power of Plants Skin Calming Day Cream Sunscreen Broad Spectrum SPF 15 50ml e 1.69 US Fl. Oz. Active ingredients: Avobenzone 3%, Octisalate 3%, Octocrylene 5%" ] }, { "effective_time": "20140102", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTIDANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "EQUALINE CLASSIC CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "0d6ea23f-5860-4a4a-a318-bf4944ea8531", "id": "26c313b9-fd6b-4e2f-96f7-70a2707faf89", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTIDANDRUFF" ] }, { "effective_time": "20101028", "drug_interactions": [ "Drug Interactions Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of Phenylephrine HCl. Sympathomimetics may reduce the effects of antihypertensive drugs." ], "precautions": [ "PRECAUTIONS General Before prescribing this medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Information For Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating dangerous machinery. Drug Interactions Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of Phenylephrine HCl. Sympathomimetics may reduce the effects of antihypertensive drugs. Carcinogenesis, Mutagenesis, and Impairment of Fertility No data is currently available on long term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow. Nursing Mothers Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended." ], "description": [ "DESCRIPTION Each dropperful (1 mL) contains: Dextromethorphan HBr.................................................................................................................... 3 mg Phenylephrine HCl........................................................................................................................ 1.5 mg Chlorpheniramine Maleate .............................................................................................................. 1 mg Dextromethorphan hydrobromide is an antitussive having the chemical name, Morphinan, 3-methoxy-17-methyl-, (9α,13α, 14α)-, hydrobromide, monohydrate with the following structure: Phenylephrine Hydrochloride is a nasal decongestant having the chemical name, Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride ( R )-. (–)- m -Hydroxy-α-[methylamino) methyl]benzyl alcohol hydrochloride, with the following structure: Molecular formula: C 18 H 25 NO•HBr•H 2 O M.W.=370.32 Molecular formula: C 9 H 13 NO 2 •HCl M.W.=203.67 Chlorpheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-chlorophenyl)- N , N -dimethyl-, (Z)-2-butenedioate (1:1). 2-[ p -Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). with the following structure: Molecular formula: C 16 H 19 ClN 2 •C 4 H 4 O 4 M.W.=390.86 Chemical Structure Chemical Structure Chemical Structure INACTIVE INGREDIENTS Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, FD&C Red No. 40, Bubblegum Flavor, Purified Water." ], "general_precautions": [ "General Before prescribing this medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness." ], "storage_and_handling": [ "Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing. Pharmacist: Dispense in original container. All prescription substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product." ], "indications_and_usage": [ "INDICATIONS For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold." ], "set_id": "0d818d1f-adcb-4c54-ba57-e94718c20e2a", "id": "b3c412c2-40a5-4f28-92a5-398df09bc8cc", "description_table": [ "
Dextromethorphan hydrobromide is an antitussive having the chemical name, Morphinan, 3-methoxy-17-methyl-, (9α,13α, 14α)-, hydrobromide, monohydrate with the following structure: Phenylephrine Hydrochloride is a nasal decongestant having the chemical name, Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. (–)-m-Hydroxy-α-[methylamino) methyl]benzyl alcohol hydrochloride, with the following structure:
Molecular formula: C18H25NO•HBr•H2O M.W.=370.32 Molecular formula: C9H13NO2•HCl M.W.=203.67
Chlorpheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). 2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). with the following structure:
Molecular formula: C16H19ClN2•C4H4O4 M.W.=390.86
" ], "teratogenic_effects": [ "Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, FD&C Red No. 40, Bubblegum Flavor, Purified Water." ], "contraindications": [ "CONTRAINDICATIONS Quartuss™ DM Drops is contraindicated in patients hypersensitive to any of its ingredients. It is also contraindicated in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy). Antihistamines should not be used to treat lower respiratory tract conditions including asthma." ], "warnings": [ "WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do no exceed recommended dosage." ], "pregnancy": [ "Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow." ], "nursing_mothers": [ "Nursing Mothers Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended." ], "spl_product_data_elements": [ "Quartuss DM Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Phenylephrine Hydrochloride Phenylephrine Dextromethorphan Hydrobromide Dextromethorphan Chlorpheniramine Maleate Chlorpheniramine sodium benzoate citric acid monohydrate sorbitol glycerin FD&C Red No. 40 water Clear" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Consult physician for dosing. Dosing is based on weight and month of age of child. May be repeated every 4-6 hours if required for relief. Not to exceed 4 doses in 24 hours. In mild cases or in particularly sensitive patients less frequent or reduced doses may be adequate." ], "adverse_reactions": [ "ADVERSE REACTIONS Dextromethorphan HBr Adverse effects with Dextromethorphan HBr are rare, but nausea and/or other gastrointestinal disturbances, headache, slight dizziness and drowsiness sometimes occur. Phenylephrine HCl Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Chlorpheniramine Maleate Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and; rarely, excitability in children." ], "spl_unclassified_section": [ "Rx ONLY Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Tri-Med Laboratories, Inc. Somerset, NJ 08873 Iss. 6/07" ], "how_supplied": [ "HOW SUPPLIED Quartuss™ DM Drops is supplied as an alcohol free, sugar free, bubblegum flavored liquid, in bottles of 1 fl. oz. (30 mL), NDC 51991-537-03, with a calibrated (1 mL) dropper. WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing. Pharmacist: Dispense in original container. All prescription substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product." ], "information_for_patients": [ "Information For Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating dangerous machinery." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Box Breckenridge Pharmaceutical, Inc NDC 51991-537-03 Quartuss™ DM Drops Antitussive/Nasal Decongestant/Antihistamine •Sugar Free •Alcohol Free Each 1 mL contains: Phenylephrine Hydrochloride ...........1.5 mg Chlorpheniramine Maleate ..................1 mg Dextromethorphan HBr .......................3 mg Inactive Ingredients: Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, FD & C Red No.40, Artificial Bubblegum Flavor, Purified Water. Rx ONLY Net Contents: 1 fl. oz. (30 mL) With Calibrated Dropper Principal Display Panel - 30 mL Box" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Dextromethorphan HBr Dextromethorphan HBr is a nonopioid antitussive agent. It suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan HBr has no significant analgesic or sedative properties. It does not depress respiration or predispose an individual to addiction with usual doses. In therapeutic dosage, Dextromethorphan HBr does not inhibit ciliary activity. The onset of action is typically within 30 minutes and the duration of action can be up to 6 hours. Dextromethorphan HBr is rapidly and extensively metabolized by the liver. It is primarily excreted in the kidneys as unchanged dextromethorphan and demethylated metabolites including dextrorphan, an active metabolite. Phenylephrine Hydrochloride Phenylephrine HCl, a nasal decongestant, is a potent postsynaptic alpha-receptor agonist with little effect on the beta receptors of the heart. Phenylephrine HCl has no effect on the beta-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Therapeutic doses of Phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of Phenylephrine HCl into tissues. The main effect of Phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of Phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. This may occur within 15 or 20 minutes and may persist for up to 4 hours. Chlorpheniramine Maleate Chlorpheniramine Maleate possesses H 1 antihistaminic activity and mild anticholinergic and sedative effects." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, and Impairment of Fertility No data is currently available on long term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans." ], "overdosage": [ "OVERDOSAGE Signs and Symptoms Overdosage with dextromethorphan HBr may produce CNS excitement and metal confusion. Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting may occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in Phenylephrine HCl overdosage through stimulation of baroreceptors. Excessive CNS stimulation may result in excitement, tremor, restlessness, and insomnia. Other effects may include pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather that a depletion of potassium. Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, uncoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon, excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable. Treatment The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants, children and comatose patients. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive." ] }, { "effective_time": "20131003", "inactive_ingredient": [ "Inactive Ingredients Water, Ethylhexyl Palmitate, Hydrogenated Methyl Abietate, Glycerin, Glyceryl Stearate Citrate, Magnesium Aluminum Silicate, Aluminum Hydroxide, Cetearyl Alcohol, Phenethyl Alcohol, Sodium Magnesium Silicate, Glyceryl Caprylate, Xanthan Gum, Alcohol, Fragrance, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Aloe Barbadensis Leaf Juice, Maris Limus Extract, Cumumis Sativus (Cucumber) Seed Extract*, Camellia Sinensis (Green Tea) Leaf Extract, Citric Acid, Potassium Sorbate, Sodium Benzoate. * Certified Organic Ingredient" ], "instructions_for_use": [ "Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Mesaure Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings: For external use only • Do not use on damaged or broken skin • When using this product keep out of eyes. Rinse with water to remove. • Stop use and ask Doctor if rash occurs • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com" ], "spl_product_data_elements": [ "Yes To Cucumbers Daily Moisturizer SPF 30 Zinc Oxide, Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER ETHYLHEXYL PALMITATE HYDROGENATED METHYL ABIETATE GLYCERYL STEARATE CITRATE GLYCERIN MAGNESIUM ALUMINUM SILICATE ALUMINUM HYDROXIDE CETOSTEARYL ALCOHOL PHENETHYL ALCOHOL LAPONITE XANTHAN GUM GLYCERYL CAPRYLATE HYDRATED SILICA ALCOHOL CUCUMBER TRIETHOXYCAPRYLYLSILANE TOCOPHEROL ALOE VERA LEAF CUCUMBER SEED SOYBEAN OIL GREEN TEA LEAF POTASSIUM SORBATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE potassium hydroxide" ], "description": [ "DRUG FACTS" ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "Principal Display Panel Image Components component label" ], "indications_and_usage": [ "Uses Helps prevent sunburn • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0d90338e-43ca-4eb9-9ede-1a84376dff8c", "id": "01072a9e-6de2-4c1b-ac13-f980994516bd", "active_ingredient": [ "Active Ingredients Zinc Oxide (11%) Titanium Dioxide (6.2%)" ] }, { "effective_time": "20130815", "inactive_ingredient": [ "Inactive ingredients water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben", "Inactive ingredients water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT", "Inactive ingredients 1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.", "Warnings Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.", "Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time" ], "spl_product_data_elements": [ "NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM PPG-2 MYRISTYL ETHER PROPIONATE TROLAMINE SALICYLATE SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYL TRIMETHICONE NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE AND ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE CYCLOMETHICONE 5 WATER GLYCERIN PHENOXYETHANOL XANTHAN GUM CHLORPHENESIN PENTYLENE GLYCOL PHENYL TRIMETHICONE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SQUALANE POLYSORBATE 60 PEG-40 STEARATE DIMETHICONE STEARYL ALCOHOL CETOSTEARYL ALCOHOL SODIUM DIHYDROXYCETYL PHOSPHATE HYDROGENATED PALM GLYCERIDES POLYOXYL 20 CETOSTEARYL ETHER CITRIC ACID MONOHYDRATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL TROPOLONE EDETATE DISODIUM POTASSIUM SORBATE SODIUM BENZOATE METHYLISOTHIAZOLINONE TETRAHEXYLDECYL ASCORBATE SODIUM POLYACRYLATE (2500000 MW) NU-DERM GENTLE CLEANSER inert WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE ALOE VERA LEAF GLYCERETH-7 PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE SAGE FD&C YELLOW NO. 5 APRICOT KERNEL OIL NU-DERM TONER inert WATER GLYCERIN HAMAMELIS VIRGINIANA TOP WATER SODIUM PYRROLIDONE CARBOXYLATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE POTASSIUM ALUM PANTHENOL SAGE CALENDULA OFFICINALIS FLOWER POLYSORBATE 80 ALLANTOIN ALOE VERA LEAF FD&C BLUE NO. 1 NU-DERM EXFODERM inert WATER GLYCERIN DIETHYLENE GLYCOL MONOETHYL ETHER METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL STEARETH-20 CANOLA OIL ISOHEXADECANE MAGNESIUM ALUMINUM SILICATE CETYL ALCOHOL FYTIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHICONE PEG-150 STEARATE PHENOXYETHANOL BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN POTASSIUM CETYL PHOSPHATE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE GLYCERETH-7 NU-DERM HYDRATE FACIAL MOISTURIZER inert WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE CAESALPINIA SPINOSA RESIN SHEA BUTTER GLYCERYL MONOSTEARATE CYCLOMETHICONE 5 CETYL ALCOHOL SACCHARIDE ISOMERATE DIMETHICONE TOCOPHEROL LAURETH-12 PHENOXYETHANOL ETHYLHEXYLGLYCERIN STEARIC ACID AVOCADO OIL SOY STEROL CAPRYLYL GLYCOL LEVOMENOL HEXYLENE GLYCOL TETRAHYDRODIFERULOYLMETHANE PANTHENOL MANGIFERA INDICA SEED BUTTER SODIUM STEAROYL GLUTAMATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALLANTOIN" ], "description": [ "Each gram of Obagi Nu-Derm Clear contains: Active ingredient Hydroquinone USP, 4% (40 mg/g) Inactive ingredients water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben", "Each gram of Obagi Nu-Derm Blender contains: Active ingredient Hydroquinone USP, 4% (40 mg/g) Inactive ingredients water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and administration Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.", "Dosage and administration Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.", "Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "spl_unclassified_section": [ "Clear (Skin Bleaching and Corrector Cream) NDC 62032-101-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only AM+PM Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.", "See enclosed Package Insert for full prescribing information. Rx ONLY. FOR EXTERNAL USE ONLY.", "Blender ® (Skin Lightener and Blending Cream) NDC 62032-100-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only PM A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. or Refissa ® Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. as prescribed by a physician.", "See enclosed Package Insert for full prescribing information. Rx ONLY. FOR EXTERNAL USE ONLY.", "Travel Bag and Patient Instruction Guide", "Obagi Hydrate is a trademark, and Blender, Exfoderm, Nu-Derm, and the Obagi logo are registered trademarks, of OMP, Inc. Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Distributed by OMP, Inc., Long Beach, CA 90806 ©2012 Obagi Medical Products, Inc. All rights reserved. obagi.com Made in USA 41706111Z 7061", "Sun Shield Broad Spectrum SPF 50 Matte Net wt. 3 oz. (85 g) This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.", "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Store at controlled room temperature 15°C–25°C (59°F–77°F).", "Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-520-00 OBAGI ® MEDICAL NU-DERM ® SYSTEM NORMAL DRY Skin Transformation Kit PRINCIPAL DISPLAY PANEL - Kit Carton" ], "indications_and_usage": [ "Indications and usage The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.", "Indications and usage The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.", "Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0d91be8e-1553-4ef7-b333-724c0e27651e", "id": "1be2dfad-d98e-4b0d-9d07-4820deb8e2aa", "active_ingredient": [ "Active ingredients Octinoxate 7.5% Zinc Oxide 10.5%" ] }, { "effective_time": "20100201", "purpose": [ "PURPOSE Protectant Vasoconstrictor Local anesthetic Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor" ], "questions": [ "Questions? Call 1-800-910-6874" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding ask a health professional before use." ], "storage_and_handling": [ "OTHER INFORMATION Store at room temperature: 20° - 25° C (68° - 77° F)" ], "indications_and_usage": [ "USES Temporarily relieves pain, soreness and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful" ], "set_id": "0dea93da-f123-4b01-b821-85ea3cd61423", "id": "dc36f647-2d3c-442b-b16d-7c0ac65414c6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression." ], "active_ingredient": [ "ACTIVE INGREDIENTS Glycerin, USP 14.4% Phenylephrine HCI, 0.25% Pramoxine HCI, 1% White petrolatum, 15%" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS aloe barbadensis leaf extract, BHA, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, tocopherol. vitamin E, xanthan gum" ], "warnings": [ "WARNINGS Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if bleeding occurs the introduction of the applicator causes additional pain condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "" ], "spl_product_data_elements": [ "glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum GLYCERIN GLYCERIN ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CARBOXYMETHYLCELLULOSE SODIUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE CETYL ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERYL MONOSTEARATE LAURETH-23 METHYLPARABEN LIGHT MINERAL OIL PANTHENOL PROPYL GALLATE PETROLATUM PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE STEARYL ALCOHOL ALPHA-TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE, DL- XANTHAN GUM" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening the tube, puncture foil seal with top end of cap Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate applicator well, then gently insert applicator into the rectum. Thoroughly clean dispensing cap after each use and replace cover Children under 12 years: ask a doctor." ], "stop_use": [ "Stop use and ask a doctor if bleeding occurs the introduction of the applicator causes additional pain condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase" ], "spl_unclassified_section": [ "" ], "do_not_use": [ "" ], "package_label_principal_display_panel": [ "PACKAGE INFORMATION - TUBE up and up NDC 11673-572-24 Hemorrhoidal Cream maximum strength Compare to Preparation H® Hemorrhoidal Cream* Helps shrink swelling of irritated hemorrhoidal tissues NET WT 1.8 OZ (51 g) This tube is sealed and packaged in a carton. Do not buy if carton is missing . Do not use if the seal under the cap has been punctured or if the tube is damaged. *This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®. Dist. by Target Corp. Minneapolis, MN 55403 Made in U.S.A. ® and © 2009 Target Brands, Inc. All Rights Reserved Shop Target.com tube", "PACKAGE INFORMATION - BOX up and up NDC 11673-572-24 Hemorrhoidal Cream maximum strength Compare to Preparation H® Hemorrhoidal Cream* Helps shrink swelling of irritated hemorrhoidal tissues NET WT 1.8 OZ (51 g) DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED. *This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Preparation H®. Distributed by Target Corporation Minneapolis, MN 55403 Made in U.S.A. ® and © 2009 Target Brands, Inc. All Rights Reserved Shop Target.com box" ] }, { "effective_time": "20140603", "inactive_ingredient": [ "Inactive Ingredients Aqua (Water), Saccharomycopsis Ferment Filtrate Pitera. , Glycerin, Dimethicone, Pentylene Glycol, Butylene Glycol, Isododecane, Polymethylsilsesquioxane, PEG-32, Sodium Hyaluronate, Caffeine, Tocopherol, Dipeptide-4, Threitol, Cyclodextrin Laurate, Dipropylene Glycol, Sodium Chloride, Sodium Citrate, PEG-15/Lauryl Dimethicone Crosspolymer, Triethanolamine, PEG-9 Polydimethylsiloxyethyl Dimethicone, Dextrin Palmitate/Ethylhexanoate, Triethoxycaprylylsilane, Xanthan Gum, Disodium EDTA, Methylparaben, Sodium Benzoate, BHT, Benzyl Alcohol, Ethylparaben, Propylparaben." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Warnings For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor. KEEP OUT OF REACH OF CHILDREN." ], "spl_product_data_elements": [ "SK-II Facial Treatment UV Protection SPF 25 Octinoxate Octinoxate Octinoxate Zinc Oxide Zinc Oxide Ensulizole Ensulizole Water Glycerin Dimethicone Pentylene Glycol Butylene Glycol Isododecane Polyethylene Glycol 1500 Hyaluronate Sodium Caffeine Tocopherol Cysteinylglycine Threitol Dipropylene Glycol Sodium Chloride Sodium Citrate Trolamine PEG-9 Polydimethylsiloxyethyl Dimethicone Triethoxycaprylylsilane Xanthan Gum Edetate Disodium Methylparaben Sodium Benzoate Butylated Hydroxytoluene Benzyl Alcohol Ethylparaben Propylparaben" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply before sun exposure.", "Directions After washing your face and conditioning your skin with a lotion, beauty essence and milky lotion, place appropriate amount of this product on palm and put on forehead, both cheeks, chin, then spread over the face. Face Wash ▶ Clear Lotion ▶ Facial Treatment Essence ▶ Beauty Essence / Milky Lotion ▶ (Figure of Facial Treatment UV Protection) Appropriate amount of usage Place 2-3 pushes amount of product on palm Advice from SK-II Spread from large area like forehead and cheek. • Much amount of usage is effective for the especially dry skin area." ], "spl_unclassified_section": [ "SK-II Protective Day Moisturising Fluid", "Active oxygen is more active during day time vs. night. So, It is important during day time to protect skin by preventing of UV rays and give skin moisture. SK-II Facial Treatment UV Protection is the beauty milky essence for UV Protection, which protects skin from UV rays stress with long-lasting moisturization. UV rays block ingredients prevent UV rays stress and high moisturizing complex moisturizes skin. So, skin moisture lasts from morning to night and skin is moisturized by keep applying. It contains SK-II Saccharomycopsis Ferment Filtrate and leads to crystal and clear skin. Protects skin from UV rays and keep the skin healthy (SPF25, PA++) Penetrates into skin quickly with light feel like water. So, fresh and light application feels Not make skin white, though it is UV protection product. Gives transparent appearance on skin Can be used as make-up base No fragrance / No colorant", "Cautions Stop use when the cosmetic product irritates your skin, or in the following cases. Since symptoms may worsen if you continue to use it, it is recommended that you consult with a dermatologist. ① When abnormalities such as redness, swelling, itching and irritation appear during use. ② When abnormalities listed above appear after the skin to which the product is applied is exposed to direct sunlight. Do not use the product for areas with abnormalities such as injuries, swelling and rashes. Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Cautions regarding storage and handling ① Make sure to tightly close the lid after use. ② Keep out of reach of children. ③ Do not store the product in direct sunlight or at an extremely high or low temperature." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Carton SK-II FACIAL TREATMENT UV PROTECTION SPF 25 30 ml e 1.0 FL. OZ. Principal Display Panel - 30 mL Carton" ], "set_id": "0e163195-1784-4d8e-b53b-581595c3f280", "id": "f3fa9a53-42f6-44d4-a6ac-3e8e97eb4bc8", "active_ingredient": [ "Active Ingredients Octinoxate 7.49%, Zinc Oxide 3.92%, Ensulizole 1.00%." ], "dosage_and_administration_table": [ "
Face Wash ▶ Clear Lotion ▶ Facial Treatment Essence ▶ Beauty Essence / Milky Lotion ▶ (Figure of Facial Treatment UV Protection)
" ] }, { "effective_time": "20150202", "inactive_ingredient": [ "Inactive Ingredients: Sodium Tallowate, Sodium Palmate, Water (Aqua), Sodium Palm Kernelate, Fragrance, Sodium Chloride, Alkyl Lactate, Propylene Glycol, Potassium Iodide, Fucus Vesiculosus Extract, Titanium Dioxide, Etidronic Acid, Linalool, Limonene, Sodium Benzoate, Potassium Sorbate." ], "purpose": [ "Triclosan 0.1% ...... Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use this product on infants under 6 months of age. in the eyes. If contact occurs, flush eyes with water. Stop use and ask a doctor if irritation and redness develops or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "dalan OCEAN BREEZE antibacterial deodorant TRICLOSAN TRICLOSAN TRICLOSAN SODIUM TALLOWATE, BEEF SODIUM PALMATE WATER SODIUM PALM KERNELATE SODIUM CHLORIDE PROPYLENE GLYCOL POTASSIUM IODIDE FUCUS VESICULOSUS TITANIUM DIOXIDE ETIDRONIC ACID LINALOOL, (+)- LIMONENE, (+)- SODIUM BENZOATE POTASSIUM SORBATE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Lather over wet skin and rinse well" ], "spl_unclassified_section": [ "dalan OCEAN BREEZE antibacterial soap deodorant soap" ], "package_label_principal_display_panel": [ "Representative Labeling OceanBreeze90gLabel OceanBreeze125gLabel" ], "indications_and_usage": [ "Uses Antibacterial Soap" ], "set_id": "0e730481-ae1a-4526-b274-188f4beb923f", "id": "009b308f-4e2b-4b83-9069-6940f8adb21f", "active_ingredient": [ "Active Ingredient / Purpose Triclosan 0.1% ...... Antibacterial" ] }, { "effective_time": "20120220", "inactive_ingredient": [ "Inactive Ingredients Purifed Water, Sodium Lauryl Glucoside Hydroxypropylsulfonate, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Mineral Blend (Malachite, Smithsonite, Rhodochrosite, and Hematite Extracts), Dimethicone, Undecylenic Acid, Mica, Titanium Dioxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Origanum Vulgare (Oregano) Leaf Extract, Citric Acid, Maris Limus (Marine Clay), Sodium Benzoate, Potassium Sorbate, Natural Fragrance." ], "purpose": [ "Purpose Controls Seborrheic Dermatitis" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Avoid contact with eyes. Rinse thoroughly with water in case contact occurs. Discontinue use and consult your physician if irritation develops." ], "questions": [ "Questions or Comments: Call 1-800-428-1668 Monday-Friday 8 AM MST-5 PM MST" ], "spl_product_data_elements": [ "Mineral Fusion Anti-Dandruff Salicylic Acid SALICYLIC ACID SALICYLIC ACID WATER COCAMIDOPROPYL BETAINE ALOE VERA LEAF MANGANESE CARBONATE DIMETHICONE UNDECYLENIC ACID MICA TITANIUM DIOXIDE TEA TREE OIL ORIGANUM VULGARE SUBSP. HIRTUM FLOWER CITRIC ACID MONOHYDRATE SODIUM BENZOATE POTASSIUM SORBATE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Gently massage into damp hair and scalp Leave on for 2-3 minutes Rinse thoroughly For best results, use regularly For maintenance, use one or two treatments per week" ], "storage_and_handling": [ "Other Information Store between 40 degrees F - 100 degrees F (4 degrees C - 38 degrees C) Protect from sunlight Protect form freezing" ], "package_label_principal_display_panel": [ "Image of Label Mineralfusionantidandruffshampoo.jpg Image of Label" ], "indications_and_usage": [ "Uses Controls recurrence of flaking, scaling, and itching associated with dandruff Helps prevent seborrheic dermatitis" ], "set_id": "0e7eb9b1-fd4e-47c0-b894-5cef79634fe9", "id": "fa6e80e4-17f5-4e61-a0a4-64e8a398ecbc", "active_ingredient": [ "Active Ingredient Salicylic Acid 2.0%" ] }, { "effective_time": "20130503", "inactive_ingredient": [ "INACTIVE INGREDIENTS / INGREDIENTS INACTIFS: Water/Eau, Cyclopentasiloxane, Ethyl Macadamiate, Glycerin, Polyglyceryl-3 Diisostearate, Oleyl Oleate, Propanediol, Ricinus Communis (Castor) Seed Oil, Polyglyceryl-3 Polyricinoleate, Magnesium Sulfate, Zinc Stearate, Ribose, Hydrogenated Castor Oil, Camellia Sinensis Leaf Extract, Buddleja Davidii Extract, Thymus Vulgaris (Thyme) Extract, Marrubium Vulgare Extract, Hexapeptide-10, Glyceryl Dibehenate, Tribehenin, Glyceryl Behenate, tocopheryl Acetate, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Bisibalol, Sodium PCA, Sodium Chloride, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate. MAY CONTAIN/PEUT CONTENIR: Titanium Dioxide (CI77891), Iron Oxides (CI77491, CI77492, CI77499)." ], "purpose": [ "PURPOSE: Makeup with SPF 15. Gives sunburn protection." ], "warnings": [ "WARNINGS: Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if signs of skin irritation develop or increase. If irritation persists, consult a health care practitioner. If swallowed, get medical help or contact a Poison Control Center right away. For external use only. Keep out of reach or children." ], "spl_product_data_elements": [ "Arbonne Sheer Finish Tinted Moisturizer Fair SPF 15 Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MAGNESIUM SULFATE, UNSPECIFIED SODIUM CHLORIDE GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE THYME POTASSIUM SORBATE SODIUM BENZOATE MACADAMIA NUT ZINC STEARATE OLEYL OLEATE ALPHA-TOCOPHEROL LEVOMENOL HYDROGENATED CASTOR OIL GLYCERYL BEHENATE TRIBEHENIN MAGNESIUM OXIDE PHENOXYETHANOL VITAMIN A PALMITATE CASTOR OIL TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE GREEN TEA LEAF MARRUBIUM VULGARE CAPRYLYL GLYCOL CYCLOMETHICONE TETRAHEXYLDECYL ASCORBATE ETHYLHEXYLGLYCERIN" ], "description": [ "Tinted Moisturizer delivers sun protection and natural-looking coverage while restoring and maintaining optimal moisture balance." ], "openfda": {}, "version": "5", "dosage_and_administration": [ "DIRECTIONS: Apply to face before sun exposure. Dispense tinted moisturizer and apply to entire face. Blend well with fingertips or sponge." ], "package_label_principal_display_panel": [ "SHEER FINISH TINTED MOISTURIZER WITH SPF 15 HYDRATANT TEINTE PUR AVEC FPS 15 ARBONNE 1.7 fl. oz/50 mL Liquid / Liquide NPN: 80014997 Sheerfinishtintedmoist" ], "set_id": "0ec9a8b2-8792-4bbf-b4dc-992d8dadf217", "id": "fb724322-dd19-4ebe-ae5b-aaed3b0ef111", "active_ingredient": [ "ACTIVE INGREDIENT / INGREDIENT ACTIF: Zinc Oxide 10% / Oxyde de zinc a 10%" ] }, { "effective_time": "20130423", "inactive_ingredient": [ "Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid." ], "purpose": [ "Purpose Stool Softener" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than one week unless directed to do so by a doctor if you are presently taking mineral oil unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition. If pregnant or breast-feeding, ask a doctor before use Keep out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx" ], "spl_product_data_elements": [ "healthy mama MOVE IT ALONG DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS STARCH, CORN SILICON DIOXIDE SODIUM BENZOATE STEARIC ACID Round Biconvex GPI;S1" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor. Children under 12 years of age: Consult a doctor before use." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a doctor before use" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information Each tablet contains: Calcium 40 mg Each tablet contains: Sodium 10 mg Store at room temperature Do not use if imprinted safety seal is broken or missing" ], "do_not_use": [ "Do not use laxative products for longer than one week unless directed to do so by a doctor if you are presently taking mineral oil unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel healthy mama MOVE IT ALONG! STOOL SOFTNER Untitleddd.jpg Untitled.jpg Untitledd.jpg" ], "indications_and_usage": [ "Uses for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "0f31b449-4ad7-4607-a3a2-23b2cbfd8778", "id": "7ccb92e7-2d83-4019-a1f2-2c1e8dbf368d", "active_ingredient": [ "Active ingredient (in each tablet) Docusate Sodium 100 mg" ] }, { "effective_time": "20100625", "inactive_ingredient": [ "Inactive Ingredients water (aqua/eau), ammonium laureth sulfate, distearyl phthalic acid amide, polyethylene, cocamidopropyl betaine, glycol stearate, cocamide MEA, jojoba esters, laureth-3, sodium chloride, sodium hydroxide, butylene glycol, guar hydroxypropyltrimonium chloride, glycerin, menthol, cetyl hydroxyethylcellulose, aloe barbadensis leaf juice, PEG-150 pentaerythrityl tetrastearate, PEG-6 caprylic/capric glycerides, camellia oleifera leaf extract, benzoic acid, sodium benzoate, fragrance (parfum), potassium sorbate, disodium EDTA, methylparaben, phenoxyethanol, chlorphenesin, ethylparaben, propylparaben, isobutylparaben, butylparaben, ultramarines." ], "purpose": [ "Purpose Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only. Do not use with another acne medication, except on the advice of a doctor. Avoid contact with eyes, if contact occurs, rinse thoroughly with water. If excessive skin irritation develops or increases, discontinue use; if irritation persists, consult a doctor. If bothersome dryness or peeling occurs, reduce application use. Keep out of reach of children." ], "when_using": [ "Avoid contact with eyes, if contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Proactiv Deep Cleansing Wash SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply to dampened skin on the body. Rinse with warm water. Pat dry." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "If excessive skin irritation develops or increases, discontinue use; if irritation persists, consult a doctor. If bothersome dryness or peeling occurs, reduce application use." ], "do_not_use": [ "Do not use with another acne medication, except on the advice of a doctor." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label Rodan & Fields p roactiv ® SOLUTION Deep Cleansing Wash NPN 80002038 8 FL. OZ. 240 mL Principal Display Panel - 240 mL Bottle Label" ], "set_id": "0f673224-27d8-48ef-b7d5-9cd7b4c83b26", "id": "fa6b5250-8c86-4188-a9de-84d4734cc41e", "active_ingredient": [ "Active Ingredients Salicylic Acid 1.0%" ] }, { "effective_time": "20151111", "inactive_ingredient": [ "Inactive ingredients Water/Aqua, Caprylic/Capric Triglyceride, Butylene Glycol, Dimethicone, Methyl Gluceth-20, Lactamide MEA, Glyceryl Stearate, Stearic Acid, Cetearyl Alcohol, Sorbitan Stearate, Sorbityl Laurate, Hydrolyzed Pearl, Silanetriol, Juglans Regia (Walnut) Seed Extract, Olea Europaea (Olive) Fruit Extract, Lavandula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Extract, Allantoin, Sodium Hyaluronate Crosspolymer, Pentylene Glycol, Glycerin, Sodium Lactate, Lactic Acid, Serine, Urea, Sorbitol, Sodium Chloride, Polysorbate 60, Cetyl Alcohol, Panthenol, Magnesium Aluminum Silicate, Xanthan Gum, Potassium Sorbate, Sodium Benzoate, Citric Acid, Disodium EDTA, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Ethylhexylglycerin, Methylpropanediol, Silica, Iron Oxides CI 77491, CI 77492, CI 77499, Titanium Dioxide CI 77891." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a Doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions? 1-800-831-5150 in USA" ], "spl_product_data_elements": [ "Sheer Tint SPF20 - Light Zinc Oxide and Octinoxate Zinc Oxide Zinc Oxide Octinoxate Octinoxate Water Potassium Sorbate Sodium Benzoate Medium-Chain Triglycerides Butylene Glycol Methyl Gluceth-20 Dimethicone N-Lactoyl Ethanolamine Glyceryl Monostearate Stearic Acid Cetostearyl Alcohol Sorbitan Monostearate Sorbityl Laurate Calcium Carbonate Silanetriol English Walnut Black Olive Lavender Oil Lavandin Oil Eucalyptus Oil Lavandula Angustifolia Flowering Top Allantoin PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer Pentylene Glycol Glycerin Sodium Lactate Lactic Acid Serine Urea Sorbitol Sodium Chloride Polysorbate 60 Cetyl Alcohol Panthenol Magnesium Aluminum Silicate Xanthan Gum Citric Acid Monohydrate Edetate Disodium Polyhydroxystearic Acid (2300 MW) Triethoxycaprylylsilane Caprylhydroxamic Acid Ethylhexylglycerin Methylpropanediol FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE Titanium Dioxide Skin Tone Light Sheer Tint SPF20 - Medium Zinc Oxide and Octinoxate Zinc Oxide Zinc Oxide Octinoxate Octinoxate Water Potassium Sorbate Sodium Benzoate Medium-Chain Triglycerides Butylene Glycol Methyl Gluceth-20 Dimethicone N-Lactoyl Ethanolamine Glyceryl Monostearate Stearic Acid Cetostearyl Alcohol Sorbitan Monostearate Sorbityl Laurate Calcium Carbonate Silanetriol English Walnut Black Olive Lavender Oil Lavandin Oil Eucalyptus Oil Lavandula Angustifolia Flowering Top Allantoin PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer Pentylene Glycol Glycerin Sodium Lactate Lactic Acid Serine Urea Sorbitol Sodium Chloride Polysorbate 60 Cetyl Alcohol Panthenol Magnesium Aluminum Silicate Xanthan Gum Citric Acid Monohydrate Edetate Disodium Polyhydroxystearic Acid (2300 MW) Triethoxycaprylylsilane Caprylhydroxamic Acid Ethylhexylglycerin Methylpropanediol FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE Titanium Dioxide Skin Tone Medium Sheer Tint SPF20 - Dark Zinc Oxide and Octinoxate Zinc Oxide Zinc Oxide Octinoxate Octinoxate Water Potassium Sorbate Sodium Benzoate Medium-Chain Triglycerides Butylene Glycol Methyl Gluceth-20 Dimethicone N-Lactoyl Ethanolamine Glyceryl Monostearate Stearic Acid Cetostearyl Alcohol Sorbitan Monostearate Sorbityl Laurate Calcium Carbonate Silanetriol English Walnut Black Olive Lavender Oil Lavandin Oil Eucalyptus Oil Lavandula Angustifolia Flowering Top Allantoin PEG-9 Diglycidyl Ether/Sodium Hyaluronate Crosspolymer Pentylene Glycol Glycerin Sodium Lactate Lactic Acid Serine Urea Sorbitol Sodium Chloride Polysorbate 60 Cetyl Alcohol Panthenol Magnesium Aluminum Silicate Xanthan Gum Citric Acid Monohydrate Edetate Disodium Polyhydroxystearic Acid (2300 MW) Triethoxycaprylylsilane Caprylhydroxamic Acid Ethylhexylglycerin Methylpropanediol FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE Titanium Dioxide Skin Tone Dark" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply: at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a Doctor if rash occurs" ], "storage_and_handling": [ "Other information Protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Light sheer tint spf 20 broad spectrum light 1.3 US Fl. Oz. 40 mL e dermalogica ® Principal Display Panel - 40 mL Tube Carton - Light", "PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Medium sheer tint spf 20 broad spectrum medium 1.3 US Fl. Oz. 40 mL e dermalogica ® Principal Display Panel - 40 mL Tube Carton - Medium", "PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - Dark sheer tint spf 20 broad spectrum dark 1.3 US Fl. Oz. 40 mL e dermalogica ® Principal Display Panel - 40 mL Tube Carton - Dark" ], "indications_and_usage": [ "Uses helps prevent sunburn. if used as directed with other sun protection measures (see Directions ), helps decrease the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "0fb056d5-2b1d-4402-825e-92c1aefb163a", "id": "d74edcd8-5557-43a6-a629-3d5cb2df5ecf", "active_ingredient": [ "Active Ingredients Octinoxate 4.5%, Zinc Oxide 9.5%" ] }, { "effective_time": "20140924", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, GLYCEIRN, MYRISTIC ACID, STEARIC ACID, SODIUM LAUROYL SARCOSINATE, PALMITIC ACID, POTASSIUM HYDROXIDE, LAURIC ACID, POLYQUATERNIUM-10, FRAGRANCE, TETRASODIUM EDTA, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, MENTHOL, ALOE BARBADENSIS LEAF JUICE, MALTODEXTRIN, POTASSIUM SORBATE, SODIUM BENZOATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN" ], "purpose": [ "PURPOSE ACNE TREATMENT" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222" ], "questions": [ "QUESTIONS OR COMMENTS? 1-800-632-6900" ], "spl_product_data_elements": [ "KROGER DAILY FACE WASH SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID WATER GLYCERIN MYRISTIC ACID STEARIC ACID SODIUM LAUROYL SARCOSINATE PALMITIC ACID POTASSIUM HYDROXIDE LAURIC ACID POLYQUATERNIUM-10 (400 CPS AT 2%) EDETATE SODIUM PENTASODIUM PENTETATE ETIDRONATE TETRASODIUM MENTHOL ALOE VERA LEAF MALTODEXTRIN POTASSIUM SORBATE SODIUM BENZOATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS USE TWICE A DAY. WET FACE AND NECK. APPLY TO HANDS WITH SOME WATER AND WORK INTO LATHER. GENTLY MASSAGE FACE AND NECK. RINSE THOROUGHLY" ], "stop_use": [ "IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222" ], "storage_and_handling": [ "OTHER INFORMATION STORE BETWEEN 20°C - 25°C (68°F - 77°F)" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES FOR THE TREATMENT OF ACNE" ], "set_id": "0fc55cdd-a76f-4acc-8449-81e9eff2a3f9", "id": "607fe7b8-e65f-4285-870c-1d41f29ab31d", "ask_doctor_or_pharmacist": [ "ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER IRRITATION OR REDNESS DEVELOPS AND LASTS KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222" ], "active_ingredient": [ "ACTIVE INGREDIENT SALICYLIC ACID 2% PURPOSE ACNE TREATMENT" ] }, { "effective_time": "20131203", "inactive_ingredient": [ "Inactive ingredients Water, sodium laureth sulfate, sodium lauryl sulfate, glycol distearate, dimethicone, cocamidopropyl betaine, sodium citrate, cocamide mea, sodium xylenesulfonate, fragrance, citric acid, sodium benzoate, guar hydroxypropyltrimonium chloride, benzyl alcohol, sodium chloride, panthenol, panthenyl ethyl ether, methylisothiazolinone." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions [or comments]? 1-800-945-7768" ], "spl_product_data_elements": [ "Pantene Pro-V Anti-dandruff pyrithione zinc pyrithione zinc pyrithione zinc water sodium laureth-3 sulfate sodium lauryl sulfate glycol distearate dimethicone cocamidopropyl betaine sodium citrate coco monoethanolamide sodium xylenesulfonate citric acid monohydrate sodium benzoate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) benzyl alcohol sodium chloride panthenol methylisothiazolinone Pantene Pro-V Anti-dandruff 2in1 pyrithione zinc pyrithione zinc pyrithione zinc water sodium laureth-3 sulfate sodium lauryl sulfate dimethicone glycol distearate cocamidopropyl betaine sodium citrate coco monoethanolamide sodium xylenesulfonate citric acid monohydrate sodium benzoate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) benzyl alcohol sodium chloride panthenol methylisothiazolinone" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wet hair, massage into hair and scalp to create lather. Rinse. for best results use at least twice a week or as directed by a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 675 mL Bottle Label FIGHTS FLAKES, ITCHING, AND IRRITATION PANTENE PRO-V Pyrithione Zinc Anti-Dandruff Shampoo ALL HAIR TYPES Anti-Dandruff SHAMPOO 92082231 22.8 FL OZ (675 mL) Principal Display Panel - 675 mL Bottle Label", "PRINCIPAL DISPLAY PANEL - 675 mL Bottle Label FIGHTS FLAKES, ITCHING, AND IRRITATION PANTENE PRO-V Pyrithione Zinc Anti-Dandruff Shampoo & Conditioner ALL HAIR TYPES 2 IN 1 Anti-Dandruff SHAMPOO & CONDITIONER 92082224 22.8 FL OZ (675 mL) Principal Display Panel - 675 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "0fcdbb02-44fa-4702-af51-de7b52b77578", "id": "ffe0adf8-e3a0-4478-b577-23eb02ceb4fa", "active_ingredient": [ "Active ingredient Pyrithione zinc 0.5%" ] }, { "effective_time": "20140321", "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 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information safety sealed: do not use if imprinted safety seal is torn or missing store between 20° and 25°C (68° and 77°F)" ], "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": "0fd1d45d-cdcf-4e67-8cd7-2263a86bd3c7", "id": "4905d89c-a40c-40ef-bbad-b3dfe93c59c4", "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder." ], "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": [ "meijer Childrens 24 Hour Allergy Loratadine Loratadine Loratadine glycerin sorbitol phosphoric acid polyethylene glycols propylene glycol water sodium benzoate sodium metabisulfite sodium phosphate, monobasic, dihydrate colorless to slightly yellow sugar free" ], "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 use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544" ], "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 - 120 mL Bottle Carton NDC 41250-999-08 Compare to Children's CLARITIN ® active ingredient* meijer ™ 2 Years and Older Children's 24 Hour Allergy Loratadine Oral Solution 5 mg/5 mL Antihistamine Indoor & Outdoor Allergies non-drowsy † 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Dye Free Sugar Free Grape Flavor children's Dosage Cup Enclosed 4 FL OZ (120 mL) † When taken as directed. See Drug Facts Panel. PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton" ] }, { "effective_time": "20140729", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS" ], "keep_out_of_reach_of_children": [ "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY ASK A DOCTOR BEFORE USING IF YOU HAVE SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH SELENIUM SULFIDE SELENIUM SULFIDE SELENIUM SULFIDE WATER AMMONIUM LAURETH-3 SULFATE AMMONIUM LAURYL SULFATE GLYCOL DISTEARATE COCO MONOETHANOLAMIDE AMMONIUM XYLENESULFONATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) SODIUM HYDROXIDE SODIUM CITRATE DIMETHICONE CETYL ALCOHOL SODIUM CHLORIDE CITRIC ACID MONOHYDRATE SODIUM BENZOATE STEARYL ALCOHOL EDETATE DISODIUM HYPROMELLOSES METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C RED NO. 4" ], "ask_doctor": [ "ASK A DOCTOR BEFORE USING IF YOU HAVE SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS SHAKE WELL. APPLY SHAMPOO, RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS" ], "set_id": "1004a6cb-2fbe-4822-800a-4f7296a82ed2", "id": "518763f2-eeb4-48e9-b869-bedc4645a175", "active_ingredient": [ "ACTIVE INGREDIENT SELENIUM SULFIDE 1% PURPOSE ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS" ] }, { "effective_time": "20120518", "inactive_ingredient": [ "Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Sorbitan Olivate, VP/Hexadecene Copolymer, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1), Chondrus Crispus (Sarrageenan) Extract (1) (2), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Laminaria Digitata Extract, Macrocystis Purifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Cetyl Alcohol, Allantoin Ascorbic Acid, Ascorbyl Glucoside, Carthamus Tinctorius (Safflower) Oleosomes, Diacetyl Boldine, Erythritol, Homarine HCl, Montmorillonite, Panthenol ,Sodium Stearoyl Glutamate, Ethylhexylglycerin, Gluconolactone, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum). (1) Certified Organic Ingredient (2) Sea Moss Extract" ], "purpose": [ "Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs." ], "questions": [ "888-659-7730, www.AlbaBotanica.com" ], "spl_product_data_elements": [ "Alba Botanica Natural Even Advanced Sea Moss Moisturizer SPF15 Homosalate, Octocrylene, Ethylhexyl Salicylate HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE SE ALOE VERA LEAF CHONDRUS CRISPUS GREEN TEA LEAF CHAMOMILE CETEARYL OLIVATE SORBITAN OLIVATE HYDROGENATED PALM KERNEL OIL CETYL ALCOHOL LAMINARIA DIGITATA SPIRULINA MAXIMA MACROCYSTIS PYRIFERA ULVA LACTUCA .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM ALCOHOL BENZYL ALCOHOL ALLANTOIN POTASSIUM SORBATE SODIUM BENZOATE ASCORBIC ACID ASCORBYL GLUCOSIDE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES DIACETYL BOLDINE ERYTHRITOL HOMARINE HYDROCHLORIDE MONTMORILLONITE PANTHENOL SODIUM STEAROYL GLUTAMATE ETHYLHEXYLGLYCERIN GLUCONOLACTONE LIMONENE, (+)- BENZYL BENZOATE .ALPHA.-HEXYLCINNAMALDEHYDE LINALOOL, (+/-)-" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply daily to clean face and neck. Apply at least 15 minutes before and every 2 hours during sun exposure. Children under 6 months: ask a doctor. Skin protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer and early skin aging." ], "package_label_principal_display_panel": [ "image of tube label image of carton label" ], "indications_and_usage": [ "Helps prevent sunburn" ], "set_id": "100cdec6-e691-4040-8193-5e544c27c327", "id": "689b437a-207a-469b-9d1b-93279bce233d", "active_ingredient": [ "Homosalate 7.5% Octocrylene 5.0% Ethylhexyl Salicylate 5.0%" ] }, { "effective_time": "20140627", "inactive_ingredient": [ "Inactive ingredients Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions (or comments)? 1-800-723-9569" ], "spl_product_data_elements": [ "Head and Shoulders 2in1 Green Apple Pyrithione Zinc Pyrithione Zinc Pyrithione Zinc water sodium lauryl sulfate sodium laureth-3 sulfate glycol distearate zinc carbonate sodium chloride sodium xylenesulfonate dimethicone cocamidopropyl betaine sodium benzoate magnesium carbonate hydroxide methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 fd&c yellow no. 5" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp, rinse, repeat if desired." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo + conditioner IMPROVES HAIR & SCALP HEALTH GUARANTEED 2 in 1 green apple for a clean fresh scent 14.2 FL OZ (420 mL) 99860229 Principal Display Panel - 420 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "100eb534-7525-4cd0-aa7e-406885faa8fd", "id": "96d04ec7-8a30-4518-aa78-802afebf9580", "active_ingredient": [ "Active ingredient Pyrithione zinc 1%" ] }, { "effective_time": "20131120", "inactive_ingredient": [ "Inactive Ingredients Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben" ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children Keep out of reach of children. Do not use on infants under 6 months of age." ], "when_using": [ "When Using This Product when using this product keep out of eyes. rinse with water to remove." ], "spl_product_data_elements": [ "La Prairie Sun Protection Face Avobenzone, Homosalate, octisalate, octocrylene, oxybenzone Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Oxybenzone Oxybenzone Hexyldecanol Dimethicone ALUMINUM STARCH OCTENYLSUCCINATE STEARETH-21 CETYL ALCOHOL SILICON DIOXIDE GLYCERIN ALOE VERA LEAF STEARETH-2 EDETATE DISODIUM SODIUM HYDROXIDE squalane POLYSORBATE 60 MEDIUM-CHAIN TRIGLYCERIDES SODIUM LACTATE CAPRYLYL GLYCOL alcohol BENZYL ALCOHOL PHENOXYETHANOL CHLORPHENESIN SODIUM BENZOATE METHYLPARABEN ETHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions Apply daily after cleansing and toning . Smooth over face and throat. Apply evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring" ], "stop_use": [ "Stop use and ask a doctor Stop use and ask a doctor if rash or irritation develops and lasts." ], "package_label_principal_display_panel": [ "Sun Protection Emulsion Face SPF 30 Sun protection emulsion face SPF 30 125mL/ 4.2 FL. OZ. image of front label" ], "set_id": "10191ef3-443c-44f4-8f5e-335e0fb8eb02", "id": "552ba652-17bd-40c1-a13c-4feb2caa811e", "active_ingredient": [ "Active Ingredients Avobenzone 3.0% Homosalate 10.0% Octisalate 2.6% Octocrylene 2.4% Oxybenzone 5.0% image of back label Keep Out Of Reach Of Children Keep out of reach of children. Do not use on infants under 6 months of age. Stop use and ask a doctor Stop use and ask a doctor if rash or irritation develops and lasts. When Using This Product when using this product keep out of eyes. rinse with water to remove. Directions Apply daily after cleansing and toning . Smooth over face and throat. Apply evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring Inactive Ingredients Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Sodium Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/ Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance ( parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propyparaben" ] } ] }