{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-05-14", "results": { "skip": 0, "limit": 100, "total": 400 } }, "results": [ { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dose." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Suphedrine PE Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM DEXTROSE MONOHYDRATE CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE 44;453" ], "ask_doctor": [ "Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use this product in children under 12 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel SAFETY SEALED Relieves Nasal and Sinus Congestion Due to Colds and Allergies Our Family® Quality Care Since 1904 Compare to the Active ingredient of Sudafed PE®* Suphedrine PE PHENYLEPHRINE HYDROCHLORIDE NASAL DECONGESTANT WITHOUT DROWSINESS 18 TABLETS Does not contain Pseudoephedrine 1 Pill Per Dose 10 mg EACH TAMPER EVIDENT: DO NOT USE IF CATON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®. 50844 REV1111E45344 DISTRIBUTED BY: NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF16559 Our Family 44-453 Our Family 44-453" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "008d8e72-739e-4ee3-b094-3cd93f5b66b1", "id": "cd6ec58d-c089-4ae7-a8da-3f64c0bba2d7", "active_ingredient": [ "Active ingredient (in each tablet) Phenylephrine HCl 10 mg" ] }, { "effective_time": "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": "20120109", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone, stearic acid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "spl_product_data_elements": [ "GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID WHITE Capsule shaped C;25" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. Directions Do not exceed 6 doses in 24 hours. Take with a full glass of water. Adults and children 12 years of age and over: 1 tablet, every4 hours Children 6 years to under 12 years: 1/2 tablet, every 4 hours Children under 6 years of age: ask a doctor Other information store between 150°- 30°C (59°- 86°F) do not use if carton is opened Inactive ingredients Croscarmellose sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone, stearic acid Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "stop_use": [ "Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness." ], "package_label_principal_display_panel": [ "Expectorant NDC number 52204-125-99 GUAIFENESIN, 400 mg" ], "set_id": "058f08dc-77de-4968-8558-1b7cf3fb39a3", "id": "058f08dc-77de-4968-8558-1b7cf3fb39a3", "active_ingredient": [ "Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant" ] }, { "effective_time": "20140113", "when_using_table": [ "
When using this product keep out of eyes. Rinse with water to remove.
" ], "inactive_ingredient": [ "Inactive Ingredients water/aqua/eau, dimethicone, coco-caprylate, caprylic/capric triglyceride, talc, dimethicone/vinyl dimethicone crosspolymer, titanium dioxide (CI 77891), cetyl peg/ppg-10/1 dimethicone, propanediol, sorbitan olivate, glyceryl tribehenate/isostearate/eicosandioate, iron oxides (CI 77491, CI 77492, CI 77499), stearalkonium hectorite, mica, alumina, sodium chloride, phenoxyethanol, tropolone, triethoxycaprylylsilane, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, aloe barbadensis leaf extract, fragrance/parfum, spilanthes acmella flower extract, olea europaea (olive) leaf extract, aluminum hydroxide, tin oxide, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, olea europaea (olive) fruit extract." ], "purpose": [ "Uses helps prevent sunburn" ], "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." ], "do_not_use_table": [ "
Do not use on damaged or broken skin
" ], "warnings": [ "Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove.", "Directions apply generously and evenly 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" ], "questions": [ "Questions or comments?Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT." ], "spl_product_data_elements": [ "Flawless by Sonya Aloe BB Creme Nude TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER DIMETHICONE COCO-CAPRYLATE MEDIUM-CHAIN TRIGLYCERIDES TALC DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) PROPANEDIOL SORBITAN OLIVATE GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE STEARALKONIUM HECTORITE MICA SODIUM CHLORIDE PHENOXYETHANOL TROPOLONE ALUMINUM OXIDE TRIETHOXYCAPRYLYLSILANE SODIUM DEHYDROACETATE PROPYLENE CARBONATE METHICONE (20 CST) ALOE VERA LEAF ACMELLA OLERACEA FLOWER OLEA EUROPAEA BARK ALUMINUM HYDROXIDE STANNIC OXIDE TRISODIUM ETHYLENEDIAMINE DISUCCINATE ALCOHOL MALTODEXTRIN BLACK OLIVE" ], "openfda": {}, "version": "7", "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "active_ingredient_table": [ "
Active Ingredient Purpose
Titanium Dioxide 7%............... Sunscreen
" ], "keep_out_of_reach_of_children_table": [ "
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
" ], "package_label_principal_display_panel": [ "label for bb creme nude box label for bb creme nude tube" ], "indications_and_usage": [ "Other Information protect the product in the enclosed container from excessive heat and direct sun" ], "set_id": "05d57c29-3d4e-45b9-9839-cd85712957ee", "id": "7b0aee80-cf83-4852-b531-3aba12fcc4b3", "warnings_table": [ "
Do not use on damaged or broken skin
", "
When using this product keep out of eyes. Rinse with water to remove.
", "
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
" ], "active_ingredient": [ "Active Ingredient Purpose Titanium Dioxide 7%............... Sunscreen" ] }, { "effective_time": "20131029", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Berry Cool Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "2.6 oz PDP DegreeMSBerryCoolPDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "05ff6d73-1a42-45ed-8bd8-1399297312da", "id": "1bbe36c8-cdda-46d2-9d8d-1436cbd6822c", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20131029", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Talc, PEG-8 Distearate, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Hydrated Silica, Maltodextrin, Gelatin Crosspolymer, Hydrolyzed Corn Starch, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Adrenaline Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL PEG-8 DISTEARATE TALC STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz DegreeExtremePDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "08cd4c79-119d-4317-8f40-7c8eb94f582e", "id": "ce9657ac-3ab4-42bc-a7a7-4d105b134523", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20130906", "inactive_ingredient": [ "Inactive Ingredients Boron nitride, glycerin, methylcellulose, maltodextrin, ascorbic acid, illite, trimyrstintin, betaine, phylantus embilica frut extract, sodium hyaluronate, hydrogenated lecithin, aloe barbensis leaf extract, retintyl palmitate, aluminum dimyristate, triethoxycaprylsilane, cyclopia intermedia leaf extract, cameria sinensis leaf extract, ectoin, tocopheryl acetate, triticum vulgare (wheat germ extract), disodium stearoyl glutamate, ferulic acid, litchi chinesis fruit extract, oryza sativa (rice) extract, disodium EDTA, rosmarinus officinalis (rosemary) extract, tetrahydrobisdemthoxydiferuloylmethane, dipotassium glycyrrhizinate, aspalathus linearis leaf extract. May contain: mica. bismuth oxychloride, titanium dioxide, iron oxides." ], "purpose": [ "Titanium Dioxide 19% Purpose: Sunscreen Zinc oxide 5% 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 1-888-795-4747" ], "spl_product_data_elements": [ "Pure Transformation Sheer Clear Titanium Dioxide and Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide boron nitride glycerin CARBOXYMETHYLCELLULOSE magnesium silicate maltodextrin silicon dioxide ascorbic acid EGG PHOSPHOLIPIDS TRIMYRISTIN betaine PHYLLANTHUS EMBLICA FRUIT hyaluronate sodium ALOE VITAMIN A PALMITATE ALUMINUM DIMYRISTATE triethoxycaprylylsilane CYCLOPIA INTERMEDIA LEAF GREEN TEA LEAF ectoine .alpha.-tocopherol acetate WHEAT GERM disodium stearoyl glutamate ferulic acid LITCHI FRUIT rice germ Edetate Disodium rosemary TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE glycyrrhizinate dipotassium aspalathus linearis leaf mica BISMUTH OXYCHLORIDE FERRIC OXIDE RED" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For sunscreen use: 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am to 2 pm, wear long-sleeve shirts, pants, hats, and sunglasses." ], "spl_unclassified_section": [ "Drug Facts", "Bare Escentuals MADE IN USA Distr. By Bare Escentuals Beauty Inc., San Francisco CA 94104 USA London W10 3QB" ], "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 - 8g Jar Label bareMinerals PURE TRANSFORMATION DAY TREATMENT BROAD SPECTRUM SPF 20 with ActiveSoil Complex CLEAR ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 19%, ZINC OXIDE 5% See box for complete drug facts information. WARNING: For external use only. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 69508 Principal Display Panel - 8g Jar 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": "09c80c29-2996-483b-a39a-779a10cb23b2", "id": "d9974e93-5303-4639-b933-5c438d49dc2f", "active_ingredient": [ "Active Ingredients Titanium Dioxide 19% Purpose: Sunscreen Zinc oxide 5% Purpose: Sunscreen" ] }, { "effective_time": "20110110", "inactive_ingredient": [ "Inactive Ingredients Water, c12-15 alkyl benzoate, homosalate octocrylene, ethylhexylmethoxycinnamate, Glycerin, cocglycerides, dimethicone, tridecyl salicylate, Ethylhexyl salycilate, butyl methoxydibenzoylmethane, tricontanyl pvp, glyceryl stearate, steareth-21, stearic acid, caprylic/capric triglyceride, aloe barbadensis gel, Maltodextrin, steareth-2, phenoxyethanol, parfum, Fragrance, peg-100 stearate, tocopheryl acetate, Xanthan gum, daucus carota extract (carrot extract), Potassium sorbate, alumina, oryza sativa cera ( rice wax), methylparaben, acrylates c10-30 alkyl acrylate Crosspolymer, dichlorobenzyl alcohol, ethylparaben, propylparaben, bisabolol, retinyl palmitate, propylene glycol, silica, panthenol, sodium polyacrylate, Hydrolyzed rice protein, hydrolyzed vegetable protein, tetrasodium edta, glicerina, sodium hydroxide, butylparaben, juglans regia leaf extract (walnut extract), BHT." ], "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 or irritation develops and lasts" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "SOL LEON Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OCTINOXATE OCTINOXATE WATER C12-15 ALKYL BENZOATE HOMOSALATE OCTOCRYLENE OCTINOXATE GLYCERIN COCO-GLYCERIDES DIMETHICONE OCTISALATE AVOBENZONE GLYCERYL MONOSTEARATE STEARETH-21 STEARIC ACID MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF MALTODEXTRIN STEARETH-2 PHENOXYETHANOL POLYOXYL 100 STEARATE VITAMIN A PALMITATE XANTHAN GUM CARROT POTASSIUM SORBATE ALUMINUM OXIDE METHYLPARABEN DICHLOROBENZYL ALCOHOL ETHYLPARABEN PROPYLPARABEN LEVOMENOL PROPYLENE GLYCOL SILICON DIOXIDE PANTHENOL EDETATE SODIUM SODIUM HYDROXIDE BUTYLPARABEN JUGLANS REGIA LEAF BUTYLATED HYDROXYTOLUENE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply evenly before sun exposure. Children under 6 months of age, ask a doctor. Reapply as needed or after towel drying, swimming or perspiring." ], "spl_unclassified_section": [ "Drug Facts", "Manufactured For: Bottega Di Lungavita Srl Via Verga, 14 Bergamo, Italia I-24127 Italy Made in Italy Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Ultra protection sun cream particularly suitable for children and those with fair and delicate skins. It ensures protection against sunburn and prevents skin rashes and age-spots." ], "stop_use": [ "Stop use and ask a doctor if rash or irritation develops and lasts" ], "package_label_principal_display_panel": [ "SOL LEON Sunscreen SPF 30 UVA UVB HIGH PROTECTION Contains Carrot Extract Bottega Di Lungavita Natural Products Italian Style of Life 6.76 fl oz (200 mL) SOLLEONa SOLLEONb" ], "indications_and_usage": [ "Uses Provides moderate protection against sunburn. For skin that sunburns easily." ], "set_id": "0b0a0312-71e6-426e-90ce-69c64533af89", "id": "4c218401-e440-4a07-80da-5fbb6041a552", "active_ingredient": [ "Active Ingredients Avobenzone 3% Homosalate 8% Octisalate 5% Octocrylene 8% Octinoxate 7.5%" ] }, { "effective_time": "20151207", "inactive_ingredient": [ "Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - Temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "spl_product_data_elements": [ "Walgreens Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Berry infused with menthol and green tea flavors menthol FD and C red No. 40 FD and C blue No. 1" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 8 mg, sodium 20 mg - phenylketonurics: contains phenylalanine 14 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage." ], "set_id": "0b64f82e-2370-43cc-9d55-dd95f79ac70a", "id": "2655a37a-6044-501b-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ] }, { "effective_time": "20150120", "inactive_ingredient": [ "Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use" ], "questions": [ "Questions or comments? 1-800-240-6373" ], "spl_product_data_elements": [ "Lab Safety Supply Non-Aspirin Acetaminophen CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES MALTODEXTRIN POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN white ROUND FR;2" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use" ], "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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel", "145R LSS Non-Aspirin 325 mg Label Rapid Comfort SM Non-Aspirin Acetaminophen 325 mg Easy to Swallow Film-Coated Tablets Pull to Open Compare Active ingredients to: Tylenol ® Registered Trademark of McNeil Consumer See new warnings information 100 Tablets (50 x 2s) Tamper Evident Unit Dose Packets 145R LSS Non-Aspirin 325 mg Label" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains associated with headache common cold muscular aches toothache minor arthritis pain menstrual cramps For the reduction of fever." ], "set_id": "0c787ab1-5a02-45a8-b239-755b57677af4", "id": "0d19f9e8-6479-147f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 325 mg" ] }, { "effective_time": "20120801", "inactive_ingredient": [ "Inactive Ingredients Lonicerae Flos, Weeping Forsythia Capsule, Fineleaf Schizonepeta Herb, Prepared Soybean, Lophatherum Herb, Great Burdock Achene, Reed Rhizome, Platycodon Root, Radix Glycyrrhizae, Vitamin C, Peppermint Oil. Excipients: Corn Starch, Stearic Acid, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Betadex, Lactose, Maltodextrin, FD&C Yellow No. 6, FD&C Green No. 3" ], "purpose": [ "Uses Temporarily relieve the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies: Fever Itiching of the nose or throat Minor aches and pains Sneezing Muscle aches Headache Runny nose Itchy eyes" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Do Not Use: Pain lasts more than 10 days Fever lasts more than 3 days If pregnant or breast-feeding, ask a health professional before using" ], "spl_product_data_elements": [ "Cold Remedy Soothing Chlorpheniramine Maleate, Acetaminophen CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ACETAMINOPHEN ACETAMINOPHEN LONICERA CONFUSA WHOLE FORSYTHIA SUSPENSA WHOLE SCHIZONEPETA TENUIFOLIA FLOWERING TOP SOYBEAN LOPHATHERUM GRACILE LEAF ARCTIUM LAPPA FRUIT PHRAGMITES AUSTRALIS ROOT PLATYCODON GRANDIFLORUM ROOT GLYCYRRHIZA URALENSIS ASCORBIC ACID PEPPERMINT OIL MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) STEARIC ACID CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MAGNESIUM STEARATE BETADEX LACTOSE MALTODEXTRIN FD&C YELLOW NO. 6 FD&C GREEN NO. 3" ], "ask_doctor": [ "Stop use and doctor if Condition worsens Symptoms persit for more than 7 days Symptoms clear up and occur again within a few days" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older Take 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hours Children ages 6 to 12 years old Take 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hours Children under 6 years of age Consult a doctor" ], "storage_and_handling": [ "Storage Store at 15°C to 30°C (59°F to 86°F) Keep away from heat Store in a dry place" ], "package_label_principal_display_panel": [ "Image image of packaging" ], "indications_and_usage": [ "While taking this product Do not use this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product, may cause excitability, especially in children May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages Use caution when driving a motor vehicle or operating machinery." ], "set_id": "0e0577fd-e7f7-4772-afce-4e935641b528", "id": "b585ed68-598a-4953-a527-fb63ae7d1dfe", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking other medications Have glaucomea A breathing problem such as emphysema or chronic bronchitis Difficulty in urination due to enlargement of the prostate gland" ], "active_ingredient": [ "Active Ingredients Chlorphenamine Maleate 1.05 mg Acetaminophen 105 mg" ] }, { "effective_time": "20141001", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, red 27 lake, yellow 10 lake, dextrose, yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. Keep out of reach of children." ], "when_using": [ "When using this product do not take more than 10 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor. Keep out of reach of children." ], "spl_product_data_elements": [ "Antacid Calcium carbonate STARCH, CORN CROSPOVIDONE D&C RED NO. 27 D&C YELLOW NO. 10 DEXTROSE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN SUCROSE TALC CALCIUM CARBONATE CALCIUM CATION CARBONATE ION bananna, orange, pineapple orange, punch G127 Reddish pink" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew 2-4 tablets as symptoms occur, or as directed by a doctor. Other information do not use if printed seal under cap is torn or missing. store at room temperature." ], "package_label_principal_display_panel": [ "Principal Display Panel Select Brand Antacid Tablets Extra Strength TROPICAL FRUIT Compare to the Active ingredient in TUMS ® EX Naturally and Artificially Flavored 96 CHEWABLE TABLETS SN" ], "indications_and_usage": [ "Uses relieves acid indigestion heartburn" ], "set_id": "0f266bad-42b0-4529-842d-e69e00094d7f", "id": "f8dc6d0f-a563-4b9a-b373-53e490b06e87", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium carbonate 750 mg" ] }, { "effective_time": "20150831", "inactive_ingredient": [ "Inactive Ingredients water, jojoba esters, steareth-2, steareth-21, corn starch modified, stearic acid, butylene glycol, stearyl alcohol, dimethicone, glycerin, epilobium angustifolium extract, melia azadirachta leaf extract, momordica charantia extract, melaleuca alternifolia (tea tree) leaf oil, cyclodextrin, allantoin, maltodextrin, sclerotium gum, phenoxyethanol, potassium sorbate, sodium hydroxide, disodium EDTA, fragrance." ], "purpose": [ "Purpose Acne Treatment" ], "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 this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water. Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases. 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 skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water." ], "questions": [ "Questions or Comments? 1-877-900-6967" ], "spl_product_data_elements": [ "Own Breakout Control Shineless Face Salicylic Acid Salicylic Acid Salicylic Acid WATER STEARETH-2 STEARETH-21 STEARIC ACID BUTYLENE GLYCOL STEARYL ALCOHOL DIMETHICONE GLYCERIN AZADIRACHTA INDICA LEAF TEA TREE OIL ALLANTOIN MALTODEXTRIN PHENOXYETHANOL POTASSIUM SORBATE SODIUM HYDROXIDE EDETATE DISODIUM" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 59mL Bottle Label Turn yourself on NATURAL CELL BOOSTER Own ™ BREAKOUT CONTROL Shineless Face Lotion CLINICALLY PROVEN INGREDIENT* 2 fl oz (59mL) Principal Display Panel - 59mL Bottle Label" ], "indications_and_usage": [ "Uses For the management of acne. Helps prevent new acne blemishes from forming." ], "set_id": "0f286caf-08c2-4660-984f-e4fb0e33d1e4", "id": "2499f9a4-725e-4ffb-adde-7c08098ffc69", "active_ingredient": [ "Active Ingredient Salicylic Acid 1%" ] }, { "effective_time": "20140107", "inactive_ingredient": [ "Inactive Ingredients Aloe Barbadensis Leaf Juice*, Water, Punica Granatum (Pomegranate) Fruit Juice, Alcohol, Propanediol, Glycerin, Chondrus Crispus (Carrageenan) Extract, Ethyl Palmate*, Xanthan Gum, Solanum Lycopersicum (Tomato) Extract, Silica, Zingiber Officinale (Ginger) Root Extract, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Bisabolol, Lavandula Angustifolia (Lavender) Oil, Sucrose Stearate, Maltodextrin, Phenethyl Alcohol, Glyceryl Caprylate, Trisodium Ethylenediamine Disuccinate, Sodium Borate. *Certified Organic Ingredient" ], "purpose": [ "Purpose Acne Treatment" ], "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 · When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with the eyes. If contact occurs, flush thoroughly with water." ], "questions": [ "Questions? 1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com" ], "spl_product_data_elements": [ "Yes To Tomatoes Daily Repair Treatment Salicylic Acid SALICYLIC ACID SALICYLIC ACID water ALCOHOL PROPANEDIOL GLYCERIN CHONDRUS CRISPUS ETHYL PALMATE XANTHAN GUM SODIUM BORATE HAMAMELIS VIRGINIANA LEAF PHENETHYL ALCOHOL ALOE VERA LEAF GLYCERYL CAPRYLATE LEVOMENOL LAVENDER OIL SUCROSE STEARATE POMEGRANATE JUICE MALTODEXTRIN TRISODIUM ETHYLENEDIAMINE DISUCCINATE TOMATO SILICON DIOXIDE GINGER CITRIC ACID MONOHYDRATE POTASSIUM HYDROXIDE" ], "warnings_and_cautions": [ "Drug Facts" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Clean the skin thoroughly before applying this product · cover the entire affected area with a thin layer one to three times daily · because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor · if bothersome dryness or peeling occurs, reduce application to once a day or every other day" ], "package_label_principal_display_panel": [ "Principal Display Panel Image Components component label carton label" ], "indications_and_usage": [ "Uses: For the treatment of acne" ], "set_id": "0f698bca-bcae-4ebf-b0f1-8eeb982b4de4", "id": "f5e8b855-707e-4624-86e3-c1b85f5e41dd", "active_ingredient": [ "Active Ingredient Salicylic Acid 1%" ] }, { "effective_time": "20150420", "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide*, croscarmellose sodium*, magnesium stearate*, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate*, stearic acid." ], "purpose": [ "Purposes Expectorant Cough Suppressant" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do Not Use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask Doctor before use if you have Ask Doctor/Pharmacist before use if you are taking sedatives or tranquilizers When Using this product ■ do not exceed recommended dosage ■ do not use for more than 7 days Stop Use and ask a doctor if ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use" ], "when_using": [ "When Using this product ■ do not exceed recommended dosage ■ do not use for more than 7 days" ], "spl_product_data_elements": [ "Mucus Relief DM Dextromehtorphan HBr / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID AZ345" ], "ask_doctor": [ "Ask Doctor before use if you have" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 12 years of age and older : Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. Children under 12 years of age : do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use" ], "stop_use": [ "Stop Use and ask a doctor if ■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel W:\\SPL-OTC\\A&Z\\Mucus Relief DM\\LB1099.jpg" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold" ], "set_id": "0f79670a-a8b3-4014-86d9-8457fba7bca6", "id": "93489726-592a-4d2a-a3f0-770b89cf700a", "ask_doctor_or_pharmacist": [ "Ask Doctor/Pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient Guaifenesin 400mg Dextromehtorphan HBr 20mg" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Cyclopentasiloxane Stearyl alcohol PPG-14 Butyl Ether Fragrance Hydrogenated Castor Oil Talc PEG-8 distearate Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Hydrated Silica Maltodextrin Gelatin Crosspolymer Hydrolyzed Corn Starch BHT Silica Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL PEG-8 DISTEARATE TALC STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz Degree V12 PDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "0fb4abaa-7fe9-4128-a97e-8e9da3c3be73", "id": "4c380459-df30-4038-8762-36878db8e90e", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.0%)" ] }, { "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": "20130702", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if ■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "do_not_use": [ "Do not use ■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "10874e99-e7fa-4994-9af8-7e203262b1cc", "id": "096b79d6-3275-42b2-99ba-fed836ade8dc", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue 1, dextrose, flavors, magnesium stearate, maltodextrin, red 40, starch, sucralose, yellow 6, yellow 10. Safety sealed: Do not use if printed seal under cap is torn or missing" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in 24 hours if pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor." ], "spl_product_data_elements": [ "up and up extra strength smooth dissolving antacid Assorted Fruit Antacid Tablets CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID FD&C BLUE NO. 1 DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 STARCH, CORN SUCRALOSE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 light RP115 assorted" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor" ], "spl_unclassified_section": [ "Other information each tablet contains: elemental calcium 300mg store below 30°C (86°F).Keep the container tightly closed" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 11673-615-90 Compare to TUMS® Smoothies Assorted Fruit* extra strength smooth dissolving antacid calcium carbonate,750 mg fast relief of heartburn, acid indigestion and upset stomach ASSORTED FRUIT FLAVOR 90 TABLETS 90 CHEWABLE TABLETS 245 05 0761 R01 ID285492 Dist.by Target Corp. Mpls.,MN 55403 Made in U.S.A ©2015 Target Brands, Inc. Shop Target.com Questions?Call 1-800-910-6874 *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS®. up and up extra strength smooth dissolving antacid assorted Fruit" ], "indications_and_usage": [ "Uses relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms" ], "set_id": "10e50d70-213b-4507-800f-fe308d0f7335", "id": "10e50d70-213b-4507-800f-fe308d0f7335", "active_ingredient": [ "Active ingredient (per tablet) Calcium Carbonate USP 750mg" ] }, { "effective_time": "20120126", "inactive_ingredient": [ "Inactive ingredients corn starch*, croscarmellose sodium*, FD&C red #40*, hypromellose, maltodextrin*, microcrystalline cellulose, polyethylene glycol, povidone*, silicon dioxide*, sodium starch glycolate*, starch*, stearic acid *may contain" ], "purpose": [ "Purposes Pain reliever/ fever reducer Expectorant 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." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor with any other drug using the above active ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease difficulty in urination due to enlargement of the prostate gland a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. symptoms do not improve within 7 days or are accompanied by a fever pain or fever persists or gets worse redness or swelling is present any new symptoms occur Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. 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." ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "Medique CCP Caffeine Free ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 HYPROMELLOSES MALTODEXTRIN POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID pink ROUND FR;40 Otis Clapp Emagrin Forte ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 HYPROMELLOSES MALTODEXTRIN POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID pink ROUND FR;40" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease thyroid disease diabetes high blood pressure heart disease difficulty in urination due to enlargement of the prostate gland a persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed Adults and children (12 years and older): Take 1 tablet with water every 4 hours. Do not take more than 6 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper evident sealed packets do not use any opened or torn packets avoid excessive heat and humidity" ], "stop_use": [ "Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. symptoms do not improve within 7 days or are accompanied by a fever pain or fever persists or gets worse redness or swelling is present any new symptoms occur" ], "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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor with any other drug using the above active ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "105R Medique CCP Label Medique® Collect MediBucks See inside flap for more details CCP Caffeine Free Acetaminophen/ Acetaminofeno 325mg Guaifenesin/Guaifenesina 200mg Phenylephrine HCl/Hidrocloruro de Fenilefrina 10mg Easy To Swallow Film Coated Tablets Facil de Tragar Tabletas con Cubierta Pelicular Pull to Open Tire Para Abrir See new warnings information 500 Tablets (250 x 2) Cold, Cough and Flu Relief Mejora el Resfriado, la Tos y la Gripe Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Untarias 105R Medique CCP Label", "105R Otis Clapp Emagrin Forte Label Otis Clapp Quality and Integrity Since 1840 EMAGRIN FORTE™ New Formula Three Way Cold & Flu Relief Without Drowsiness See Warnings and Directions on Side Panel See new warnings information Acetaminophen 325mg Guaifenesin 200mg Phenylephrine HCl 10mg Tear Out Along Perforation To Dispense PROFESSIONAL HEALTHCARE 300 Tablets (150 PACKETS OF 2) 105R Otis Clapp Emagrin Forte Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache muscular aches minor arthritis pain common cold toothache menstrual cramps Temporarily relieves nasal congestion due to common cold hay fever or other respiratory allergies Temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive promotes nasal and/or sinus drainage; relieves sinus congestion and pressure" ], "set_id": "11c04d2f-8bfc-4d65-857f-cb5d3b1e7799", "id": "d2de3e9e-40e1-4e21-85b0-f72375962af4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 325 mg Guaifenesin 200mg Phenylephrine Hydrochloride 10mg" ] }, { "effective_time": "20121012", "inactive_ingredient": [ "Inactive ingredients Acacia Gum, Calcium Carbonate, Croscarmellose Sodium, Dextrose, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Propylene Glycol, Silicon Dioxide, Stearic Acid, Triacetin." ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Adverse Drug Event call (800) 616-2471" ], "spl_product_data_elements": [ "Senna-Lax SENNOSIDES A AND B SENNOSIDES A AND B SENNOSIDES A AND B ACACIA CALCIUM CARBONATE CROSCARMELLOSE SODIUM DEXTROSE HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TRIACETIN Biconvex GPI;W2" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years of age ask a doctor ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "do_not_use": [ "Do not use laxative products for longer than 1 week unless directed by a doctor" ], "package_label_principal_display_panel": [ "Sennosides 8.6mg Tablet Image File" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces a bowel movement in 6-12 hours" ], "set_id": "1283a8ff-00f4-11af-4357-ae102066fe65", "id": "5a42b29a-d47a-4c3e-aeeb-d93415d715f9", "active_ingredient": [ "Active ingredient (in each tablet) Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
age starting dosage maximum dosage
adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day
children under 2 years of age ask a doctor ask a doctor
" ] }, { "effective_time": "20131115", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product. Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exeed recommended dosage. Stop use and ask a doctor if new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 7 days redness or swelling is present nervousness, dizziness, or sleeplessness occur cough comes back or occurs with rash or headache that lasts fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exeed recommended dosage." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Maximum Strength Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN FD&C BLUE NO. 1 MALTODEXTRIN CROSPOVIDONE MAGNESIUM STEARATE 44;616" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur pain, nasal congestion, or cough gets worse or lasts more than 7 days redness or swelling is present nervousness, dizziness, or sleeplessness occur cough comes back or occurs with rash or headache that lasts fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product." ], "package_label_principal_display_panel": [ "Principal display panel exchange select™ *Compare To The Active Ingredients in Maximum Strength Mucinex® FAST-MAX™ Cold, Flu & Sore Throat For Ages 12 & Over MAXIMUM STRENGTH MUCUS RELIEF Cold, Flu & Sore Throat Acetaminophen Pain Reliever / Fever Reducer Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Phenylephrine HCl - Nasal Decongestant Relieves Headache & Fever Relieves Nasal & Chest Congestion Thins & Loosens Mucus Controls Cough 20 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING SATISFACTION GUARANTEED OR YOUR MONEY BACK Manufactured For: Your Military Exchanges Distributed by: LNK International, Inc. Hauppauge, NY 11788 *This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX™ Cold, Flu & Sore Throat. 50844 ORG011361609 KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION Exchange Select 44-616 Exchange Select 44-616" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: nasal congestion sore throat headache minor aches and pains cough temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive" ], "set_id": "13faf3ae-207f-4529-9493-0b3c18d9c8a9", "id": "6f9e89eb-5725-4709-854d-1273ddef7a90", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20120524", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you have kidney stones a calcium-restricted diet Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 15 tablets in 24 hours do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product do not take more than 15 tablets in 24 hours do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-800-616-2471" ], "spl_product_data_elements": [ "Calcium Carbonate calcium carbon CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID DEXTROSE MALTODEXTRIN MINERAL OIL POLYETHYLENE GLYCOLS POWDERED CELLULOSE TALC L478 Cherry, lemon, lime, orange" ], "ask_doctor": [ "Ask a doctor before use if you have kidney stones a calcium-restricted diet" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions chew 2 - 4 tablets as symptoms occur, or as directed by a doctor" ], "package_label_principal_display_panel_table": [ "
Bottles of 60 NDC 54868-2399-1
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 215 mg and magnesium 5 mg store at 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel CALCIUM Antacid Tablets Regular Strength ANTACID/CALCIUM SUPPLEMENT Calcium Carbonate 500 mg Assorted Fruit Naturally & Artificially Flavored Bottles of 60 NDC 54868-2399-1 image of package label" ], "indications_and_usage": [ "Uses relieves heartburn sour stomach acid indigestion upset stomach associated with these symptoms" ], "set_id": "14021627-2204-4f7e-83da-d3d4059208ca", "id": "587ea494-b2d2-40d6-8c4f-a74e435d23ae", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (in each tablet) Calcium carbonate USP 500mg" ] }, { "effective_time": "20150421", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "questions": [ "Questions or Comments? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "14ca3278-8f48-4a46-b30f-35c41c5d5240", "id": "a2d63bad-4e8e-4477-872a-750de9bc7f47", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use in a child under 4 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Rite Aid Daytime Severe Cold and Cough Relief Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Dextromethorphan hydrobromide Dextromethorphan Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton RITE AID ® PHARMACY SEE NEW WARNINGS INFORMATION & DIRECTIONS * Compare to the active ingredients in Theraflu ® Severe Cold & Cough daytime severe cold & cough relief acetaminophen 650 mg dextromethorphan HBr 20 mg phenylephrine HCl 10 mg pain reliever/fever reducer cough suppressant & nasal decongestant relieves: nasal & sinus congestion cough body ache sore throat pain headache fever berry infused with menthol & green tea flavors 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg Cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "questions_table": [ "
Amount Per Serving %Daily Value
Calories 10
Sugars 2g
Calcium 600mg 60%
Sodium 5mg (less than 1%)
Magnesium 2mg (less than 1%)
" ], "effective_time": "20141107", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, sorbitol, dextrose, sucrose, microcrystalline cellulose, magnesium stearate, natural and artificial flavors, adipic acid, corn starch, guar gum, maltodextrin, red 40 lake, blue 1 lake. Contains soy" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product • do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? 1-800-897-7535 weekdays CALCIUM SUPPLEMENT USES: As a daily source of extra calcium. DIRECTIONS: Chew 2 tablets twice daily with a meal. Supplement Facts Serving Size: 2 Tablets Servings Per Container: 30 Amount Per Serving %Daily Value Calories 10 Sugars 2g Calcium 600mg 60% Sodium 5mg (less than 1%) Magnesium 2mg (less than 1%) Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 TUMS and SMOOTHIES are trademarks of the GlaxoSmithKline group of companies. www.tums.com" ], "spl_product_data_elements": [ "Tums calcium carbonate Tums Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SORBITOL DEXTROSE SUCROSE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE ADIPIC ACID STARCH, CORN GUAR GUM MALTODEXTRIN FD&C RED NO. 40 ALUMINUM OXIDE FD&C BLUE NO. 1 SOYBEAN mauve, peach, dark pink TUMS;SD Berry Fusion, citrus berry, orange passion, strawberry Tums Extra Strength calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SUCROSE STARCH, CORN TALC MINERAL OIL ADIPIC ACID SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 TUMS Assorted Fruit Flavor" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions chew 2 – 4 tablets as symptoms occur, or as directed by a doctor" ], "spl_unclassified_section": [ "Other information • for calcium/magnesium/sodium content see Supplement Facts • store below 25 o C (77 o F). Keep the container tightly closed." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0555-01 TUMS ® EXTRA STRENGTH 750 ANTACID ASSORTED FRUIT 8 Chewable TABLETS TUMS ® ANTACID / CALCIUM SUPPLEMENT Smoothies TM EXTRA STRENGTH 750 CALCIUM RICH SMOOTH DISSOLVE BERRY FUSION NATURALLY & ARTIFICIALLY FLAVORED PAREVE FREE TUMS ® 8ct Roll 60ct Bottle – Smoothies Berry Fusion 8ct Roll – EX Assorted Fruit ©2012 GlaxoSmithKline 102777PA Tums copack Smoothies Berry Fusion 60ct and Extra Strength Assorted Fruit 8ct carton" ], "indications_and_usage": [ "Uses relieves • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms" ], "set_id": "15eb7ac5-530c-46bf-add0-98a064287009", "id": "0ef73ab8-7bb4-426f-aff9-a6bc010f2a0e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (per tablet) Calcium carbonate USP 750 mg" ] }, { "effective_time": "20151016", "inactive_ingredient": [ "Inactive ingredients FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Mucus Relief Chest Guaifenesin GUAIFENESIN GUAIFENESIN FD&C BLUE NO. 1 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONES SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;532" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take with a full glass of water adults and children 12 years of age and over : 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years : do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 49035-555-11 Immediate-Release Mucus Relief Chest Guaifenesin 400 mg • Expectorant Relieves Chest Congestion Thins and Loosens Mucus QUALITY GUARANTEED 60 Tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0812D53211 Wal-Mart 44-532 Wal-Mart 44-532" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom mucus and make coughs more productive" ], "set_id": "161af4aa-328b-4a49-9354-cee2ba67db19", "id": "f56c5d22-5698-4017-b064-b3f864a78a03", "active_ingredient": [ "Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg" ] }, { "effective_time": "20110729", "inactive_ingredient": [ "Inactive ingredients D&C red #30 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinylpyrrolidine, pregelatinized starch, silicon dioxide, stearic acid" ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "spl_product_data_elements": [ "ORGAN-I NR guaifenesin GUAIFENESIN GUAIFENESIN D&C RED NO. 30 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE STARCH, PREGELATINIZED CORN SILICON DIOXIDE STEARIC ACID rose colored 4740;V" ], "ask_doctor": [ "Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than 6 doses in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over 1 - 2 tablets every 4 hours children under 12 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "spl_unclassified_section": [ "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 .", "Made in the USA for Qualitest Pharmaceuticals Huntsville, AL 35811 Rev. 3/11 R5 8080143 4740 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Organ-I NR 200mg" ], "indications_and_usage": [ "Use helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "17e6ba6d-a80f-4e8a-8435-8dca701f1c3a", "id": "96c89e90-4db0-49df-bf0e-62991cc1dadb", "active_ingredient": [ "Active ingredient Guaifenesin, USP 200 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 - 2 tablets every 4 hours
children under 12 years do not use
" ] }, { "effective_time": "20131030", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "1.6 oz PDP DegreeMSSexyIntriguePDP", "2.6 ox PDPb DegreeMSSexyIntriguePDPb" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "187be720-2b90-4300-878c-9f9d86d1b525", "id": "af84c5a7-e40c-4e89-8a20-d7e2e7037251", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20140404", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Quality Choice Mucus Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if ■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "do_not_use": [ "Do not use ■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "18b3ac1b-408d-4658-8fc9-68ee1f05cefd", "id": "a3f885ab-8205-4c5d-8eac-ec6897cdd41a", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20151118", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dextrose, monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesiums stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "when_using": [ "When using this product do not exceed recommended dose." ], "questions": [ "Questions? 1-888-287-1915" ], "spl_product_data_elements": [ "Nasal Decongestant PE Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM DEXTROSE MONOHYDRATE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE TITANIUM DIOXIDE 44;453" ], "ask_doctor": [ "Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use this product in children under 12 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal display panel NDC 49035-453-23 equate® Compare to Sudafed PE® Active Ingredient* Maximum Strength Nasal Decongestant PE Phenylephrine HCl 10 mg Non-Drowsy Relieves: • Sinus pressure • Congestion 10 mg 72 TABLETS Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 ©Wal-Mart Stores, Inc. *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Sinus Headache. 50844 REV0313A45323 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Equate 44-453 Equate 44-453" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "18cdfcb9-6abd-4208-976c-927ab7f24c59", "id": "469b107d-1d87-4bda-b8bf-ab088186f1c3", "active_ingredient": [ "Active ingredients (in each tablet) Phenylephrine HCl 10 mg" ] }, { "effective_time": "20101229", "inactive_ingredient": [ "Other Ingredients Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcelluslose, Dicalcium Phosphate, dI-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflaving. Contains Soy. May contain Povidone and Polydextrose. Contains No artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk based by-products." ], "contraindications": [ "CONTRAINDICATIONS Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately." ], "precautions": [ "PRECAUTIONS Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "warnings": [ "WARNINGS Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins." ], "spl_product_data_elements": [ "Multi-Nate 30 beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION CAPRYLIC/CAPRIC MONO/DIGLYCERIDES CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE MALTODEXTRIN STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE ACACIA SODIUM ALGINATE POLYETHYLENE GLYCOL SUCROSE STARCH, CORN HYDROGENATED SOYBEAN OIL HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE ALPHA-TOCOPHEROL, DL- TITANIUM DIOXIDE TRIACETIN POLYSORBATE 20 RIBOFLAVIN RE;316" ], "openfda": {}, "version": "11", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one tablet by mouth daily, or as directed by a physician." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088." ], "how_supplied": [ "HOW SUPPLIED Multi-Nate 30 is available as a dark pink tablet imprinted “RE 316”: bottles of 100 tablets NDC 68032-444-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store a controlled room temperature 15-30C (59-86F). Keep in a cool, dry place. WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only" ], "package_label_principal_display_panel": [ "PACKAGING label" ], "indications_and_usage": [ "INDICATIONS AND USAGE Multi-Nate 30 is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception. Multi-Nate 30: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid." ], "set_id": "195435f6-3c9b-4ac5-9502-859ef03c7523", "id": "7164daaf-b77f-4bff-bb44-8b7623cf52c2" }, { "effective_time": "20100929", "inactive_ingredient": [ "magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children, In ase of overdose, get medical help or contact a Poison Center immediately" ], "purpose": [ "Purpose Cough Suppressant 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. package label" ], "spl_product_data_elements": [ "CVS Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Guaifenesin MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE, COLLOIDAL COPOVIDONE MALTODEXTRIN STEARIC ACID PH073" ], "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 610 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) Rev 10/U9 RCCF" ], "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" ], "do_not_use": [ "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." ], "package_label_principal_display_panel": [ "Enter section text here" ], "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": "19dfdf4d-4a58-4ffb-8d62-394fcaaa7298", "id": "74179880-e043-40b7-ba3a-8a3e7a5cc557", "active_ingredient": [ "Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Cough Suppressant Guaifenesin 400mg Expectorant" ] }, { "effective_time": "20100128", "inactive_ingredient": [ "Inactive Ingredients Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Dimethicone, Polyglyceryl-3 methylglucose distearate, C18-36 acid glycol ester, Butyrospermum parkii (Shea butter), Aesculus hippocastanum (Horsechestnut) extract, Theobroma cacao (Cocoa) seed butter, Phenoxyethanol, VP/hexadecene copolymer, Sodium benzoate, Parfum (Fragrance), Methylparaben, Acrylates/vinyl isodecanoate crosspolymer, Tetrasodium EDTA, Butylparaben, Ethylparaben, Potassium hydroxide, Maltodextrin, Propylparaben, Isobutylparaben, Dipropylene glycol, Silica, BHT" ], "purpose": [ "Uses Provides moderate protection against the adverse effects of the sun Higher SPF gives more protection" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help." ], "questions": [ "Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE WATER BUTYLENE GLYCOL DIMETHICONE SHEA BUTTER PHENOXYETHANOL SODIUM BENZOATE COCOA BUTTER HORSE CHESTNUT METHYLPARABEN BUTYLPARABEN ETHYLPARABEN POTASSIUM HYDROXIDE MALTODEXTRIN PROPYLPARABEN SILICON DIOXIDE BUTYLATED HYDROXYTOLUENE" ], "description": [ "Plant extracts at levels that really work, combined and formulated for outstanding product performance. Naturally. A triple action formulation for a complete daily skincare routine: moisturises, protects and promotes healthy looking skin. Horsechestnut extract a powerful anti-oxidant and SPF15 help protect against premature skin ageing. Dermatologically tested." ], "warnings_and_cautions": [ "Warnings For external use only When using this product keep out of eyes. If contact occurs rinse thoroughly with cold water. Avoid direct contact with fabric." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "openfda": {}, "version": "2", "storage_and_handling": [ "Other Information Do not store above 30 0 C or 86 0 F" ], "how_supplied": [ "Colour may vary due to natural extracts" ], "information_for_patients": [ "Mfd in the U.K. for BBI NG2 3AA. UK. Dist in the USA by Boots Retail USA Inc. Stamford CT 06901 www.boots.com" ], "package_label_principal_display_panel": [ "Carton label Normal/Dry Skin Triple Action Day Moisture Cream Sunscreen SPF 15 PEAU NORMALE ET SECHE Crème Hydratante de Jour ā Triple Action FPS 15 Boots The Power of Plants BOTANICS 50ml e 1.69 US Fl. Oz TA Day Moisture Cream carton.jpg TA Day Moisture Cream carton", "Jar front label Triple Action Day Moisture Cream Sunscreen SPF 15 Horsechestnut protects Crème Solaire Hydratante de Jour ā Triple Action FPS 15 Le Marronnier d'Inde protège Boots The Power of Plants BOTANICS 50ml e 1.69 US Fl. Oz TA Day Moisture Cream front label.jpg TA Day Moisture Cream front label", "Jar back label Dermatologically tested WARNINGS: Avoid getting directly in eyes. If contact occurs rinse thoroughly with cold water. Avoid direct contact with fabric. Colour may vary due to natural extracts. Dermo-teste MISE EN GARDE: Éviter tout contact avec les yeux. En cas de projection, rincer immédiatement ā l'eau froide. Éviter tout contact direct avec du tissu. La couleur peut varier en raison des extraits naturels. ACTIVE INGREDIENTS/ACTIFS: Avobenzone 3.0% Octinoxate 4.5% Mdf in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK. Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901 USA/Canada: Questions? 1-866-75-BOOTS www.boots.com TA Day Moisture Cream back label.jpg TA Day Moisture Cream back label" ], "indications_and_usage": [ "DIRECTIONS Massage onto face and neck with gentle upward strokes. Apply evenly at least 15 minutes before sun exposure. Reapply as required. Not intended for children under the age of 12. Not intended for protection while sunbathing." ], "set_id": "1a3705cf-d80a-470c-98ea-a58429d958ca", "id": "bd355393-0a28-4ce0-ba32-fb588a9c2982", "active_ingredient": [ "Active Ingredients Purpose Avobenzone 3.0% Sunscreens Octinoxate 4.5%" ] }, { "effective_time": "20140926", "inactive_ingredient": [ "Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid. image of display" ], "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 Center immediately." ], "warnings": [ "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": [ "Select Brand Mucus Relief DM Dextromethorphan Hydrobromide / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Guaifenesin SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN STEARIC ACID PH073" ], "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 (mucus)" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, 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." ], "storage_and_handling": [ "Other Information Store at 15°-30°C (59°-86°F)" ], "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": "1ab81134-1e22-4d0f-975a-4df1022b24cb", "id": "77f0990c-df64-42f6-b291-889049944454", "active_ingredient": [ "Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg" ] }, { "effective_time": "20140103", "inactive_ingredient": [ "Inactive Ingredients Water, Punica Granatum (Pomegranate) Fruit Juice, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol 38B, Propanediol, Solanum Lycopersicum (Tomato) Extract*, Aloe Barbadensis Leaf Extract, Chondrus Crispus (Carrageenan) Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Juice, Zingiber Officinale (Ginger) Root Extract*, Bisabolol, Maltodextrin, Glyceryl Caprylate, Sucrose Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Silica, Phenethyl Alcohol, Xanthan Gum, Alcohol. *Certified Organic Ingredient" ], "purpose": [ "Purpose Acne Treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings: For external use only. Flammable - Keep away from open fire or flame. Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product, as this may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water." ], "questions": [ "Questions? 1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com" ], "spl_product_data_elements": [ "YES TO TOMATOES ROLLER BALL SPOT STICK Salicylic Acid SALICYLIC ACID SALICYLIC ACID water ALCOHOL HAMAMELIS VIRGINIANA LEAF PROPANEDIOL LAVENDER OIL CHONDRUS CRISPUS GRAPEFRUIT JUICE PHENETHYL ALCOHOL MALTODEXTRIN POMEGRANATE JUICE XANTHAN GUM SUCROSE STEARATE GLYCERYL CAPRYLATE LEVOMENOL TEA TREE OIL ALOE VERA LEAF TOMATO SILICON DIOXIDE GINGER LIMONENE, (+/-)-" ], "warnings_and_cautions": [ "Drug Facts" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply Spot Stick directly on blemishes 1 - 3 times daily. Because excessive drying of skin may occur start with one application and gradually increase as needed." ], "package_label_principal_display_panel": [ "Principal Display Panel Image Components Bottle label Unit Carton label" ], "indications_and_usage": [ "Uses: for the treatment of acne" ], "set_id": "1abfc187-b7aa-4464-ae6d-2496de96114d", "id": "52a0349e-f327-4681-9491-d38cf5ce7776", "active_ingredient": [ "Active Ingredient Salicylic Acid 2%" ] }, { "effective_time": "20150212", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue 1 lake, corn starch, crospovidone, dextrose, flavors, gum acacia, magnesium stearate, maltodextrin, red 40 lake, silicon dioxide, sucrose, talc, yellow 5 (tartrazine) lake, yellow 6 lake." ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product do not take more than 10 tablets in 24 hours do not use the maximum dosage for more than 2 weeks" ], "spl_product_data_elements": [ "PharmaRight Extra Strength Antacid ASSORTED FRUIT CALCIUM CARBONATE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION ADIPIC ACID FD&C BLUE NO. 1 STARCH, CORN CROSPOVIDONE DEXTROSE ACACIA MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 SILICON DIOXIDE SUCROSE TALC FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 Cherry - Medium Red Orange - Bright Redish Orange Lemon - Deep To Medium Yellow Lime - Medium Greeen CO2 Assorted Fruit" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions chew 2 - 4 tablets as symptoms occur, or as directed by a doctor" ], "spl_unclassified_section": [ "PharmaRight Extra Strength Antacid ASSORTED FRUIT", "Manufactured by: Smith Brothers Co. Chicago, IL 60632 www.thesmithbrothers.com" ], "storage_and_handling": [ "Other information store below 25 degrees C (77 degrees F) Safely sealed Do not use if wrapping is damaged." ], "package_label_principal_display_panel": [ "PharmaRight Extra Strength Antacid ASSORTED FRUIT 12 Chewable TABLETS (76461-599-12) Label" ], "indications_and_usage": [ "Uses relieves heartburn sour stomach acid indigestion" ], "set_id": "1b2db23e-61f4-4ab8-878d-30c96cb01215", "id": "2c44c283-7903-47e3-bdf2-b29336ecde92", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (per tablet) Calcium Carbonate 750mg" ] }, { "effective_time": "20151105", "precautions": [ "PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "purpose": [ "Purpose Skin Protectant" ], "description": [ "DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure" ], "general_precautions": [ "General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled." ], "storage_and_handling": [ "Other information ■ protect from freezing ■ avoid excessive heat" ], "indications_and_usage": [ "INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.", "Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin" ], "set_id": "1b48175c-a3df-0ab3-e054-00144ff88e88", "id": "23d89b4f-da86-6b2c-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient Dimethicone 5.0%" ], "pediatric_use": [ "Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "inactive_ingredient": [ "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine." ], "contraindications": [ "CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation." ], "pregnancy": [ "Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time." ], "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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "nursing_mothers": [ "Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman." ], "spl_product_data_elements": [ "Dermasilkrx SDSpak Triamcinolone Acetonide Cream, Dimethicone Cream Triamcinolone Acetonide Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Skin Repair Complex Dimethicone KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE DIMETHICONE DIMETHICONE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ■ apply cream liberally as needed" ], "adverse_reactions": [ "ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria" ], "spl_unclassified_section": [ "Triamcinolone Acetonide Cream USP (0.1%) DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 67877-251-80 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.", "Skin Repair Complex (Dimethicone 5.0%) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin 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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions ■ apply cream liberally as needed Other information ■ protect from freezing ■ avoid excessive heat Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.", "Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours." ], "laboratory_tests": [ "Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test" ], "how_supplied": [ "HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 67877-251-80 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION." ], "information_for_patients": [ "Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings." ], "package_label_principal_display_panel": [ "SDS pak- carton new_sdes_box_72_dpi" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results." ], "overdosage": [ "DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted." ] }, { "effective_time": "20130228", "inactive_ingredient": [ "INGREDIENTS aqua (water), ethoxydiglycol, butylene glycol, glycereth-7 trimethyl ether, aminomethylpropanol, potassium azeloyl, diglycinate, syringa vulgaris (lilac) leaf cell culture extract, dipotassium glycyrrhizate, urea, angelica sinensis extract, avena sativa (oat) extract, avena sativa (oat) kernel extract, hamamelis virginiana (witch hazel) , bark/leaf/twig extract, papain, betaine, calcium pantothenate, proline, Alanine, serine, magnesium lactate, potassium lactate, lecithin, glycerin, maltodextrin , ethylhexylglycerin, sodium citrate, xanthan gum, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, magnesium chloride, benzyl alcohol , sorbic acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin" ], "purpose": [ "PURPOSE ACNE TREATMENT" ], "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 SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION. SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME." ], "spl_product_data_elements": [ "BLEMISH CORRECTING SERUM SENSITIVE SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID WATER DIETHYLENE GLYCOL MONOETHYL ETHER BUTYLENE GLYCOL GLYCERETH-7 TRIMETHYL ETHER AMINOMETHYLPROPANOL POTASSIUM AZELOYL DIGLYCINATE SYRINGA VULGARIS WHOLE GLYCYRRHIZINATE DIPOTASSIUM UREA ANGELICA SINENSIS WHOLE AVENA SATIVA TOP HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PAPAIN BETAINE CALCIUM PANTOTHENATE PROLINE ALANINE SERINE MAGNESIUM LACTATE POTASSIUM LACTATE LECITHIN, SOYBEAN GLYCERIN MALTODEXTRIN ETHYLHEXYLGLYCERIN SODIUM CITRATE XANTHAN GUM HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM MAGNESIUM CHLORIDE BENZYL ALCOHOL SORBIC ACID CAPRYLYL GLYCOL PHENOXYETHANOL" ], "other_safety_information": [ "Other Information Store at 20-25 DEGREES CELCIUS (68-78 DEGREES FAHRENHEIT)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS. AVOID THE DELICATE EYE AREA. START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO TIMES DAILY IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. CONSULT A PHYSICIAN BEFORE USE." ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION OR SENSITIVITY DEVELOPS OR INCREASES." ], "do_not_use": [ "DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN ARE SENSITIVE TO BENZOYL PEROXIDE" ], "package_label_principal_display_panel": [ "BB_Blemish Correcting Serum-Sensitive-SA CX620S BB_Blemish Correcting Serum-Sensitive-SA_1oz_Tubes_ARTWORK_FR" ], "indications_and_usage": [ "USES TREATS ACNE DRIES UP ACNE PIMPLES HELPS PREVENT NEW ACNE PIMPLES" ], "set_id": "1b808bcc-0751-4a24-9f9a-339563b56106", "id": "27fdba83-576d-4d5c-8bd5-f61967fb62b3", "active_ingredient": [ "ACTIVE INGREDIENT SALICYLIC ACID 2%" ] }, { "effective_time": "20120202", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Dimethicone Paraffin Microcrystalline Wax Fragrance (Parfum) Silica Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Dimethicone Crosspolymer Hydrated Silica Maltodextrin Gelatin Crosspolymer Hydrolyzed Corn Starch Cellulose Gum BHT" ], "purpose": [ "Purpose anti-perspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree Clinical Protection Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 DIMETHICONE MICROCRYSTALLINE WAX SILICON DIOXIDE HYDRATED SILICA MALTODEXTRIN STARCH, CORN GELATIN CARBOXYMETHYLCELLULOSE SODIUM BUTYLATED HYDROXYTOLUENE PARAFFIN" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ▪ apply to underarms only ▪ before bed, apply two clicks of product to each underarm" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz Degree Clinical Motion Sexy Intrigue PDP", "PDP 2.7 oz carton Degree Clinical Motion Sexy Intrigue Carton" ], "indications_and_usage": [ "Uses ▪ reduces underarm wetness ▪ 24 hour protection ▪ extra effective" ], "set_id": "1c5bc184-966f-432b-8f08-ca6efb0890c2", "id": "04784ca5-cd6e-42bd-b187-6b5447e27f31", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (20%)" ] }, { "effective_time": "20121213", "inactive_ingredient": [ "Inactive Ingredients croscarmellose sodium, magnesium sterate, maltodextrin, microcrystalline cellulose, stearic acid" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Other Information Each tablet contains: calcium 260 mg store at room temperature 15°-30°C (59°-86°F)" ], "warnings": [ "Warnings taking a prescription drug. Antacids may interact with certain prescription drugs. Ask a doctor or pharmacist before use if you are symptoms last more than 2 weeks. Stop use and ask a doctor if , ask a health professional before use. If pregnant or breast-feeding Keep out of reach of children." ], "questions": [ "Questions or Comments Call Monday – Friday, 9 am – 5 pm ET 1-800-645-2158, TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING This is a bulk pakage, dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP. Mfd for: Rugby Laboratories,Inc" ], "spl_product_data_elements": [ "Calcium carbonate Calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE STEARIC ACID off white AP;025" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take one to four tablets daily do not take more than 4 tablets in 24 hours do not use the maximum dosage for more than 2 weeks" ], "package_label_principal_display_panel": [ "CALCIUM CARBONATE TABLET Label Image" ], "indications_and_usage": [ "Use relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms" ], "set_id": "1cd621d0-58b9-45f7-80fb-e13ca68596a1", "id": "7e5037b1-4d47-4454-8cde-b93717dbcb54", "active_ingredient": [ "Active Ingredient (in each tablet) Calcium carbonate 10 gr (648 mg)" ] }, { "effective_time": "20151013", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount 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 for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage." ], "spl_product_data_elements": [ "Severe Multi-Symptom Cold Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 MAGNESIUM STEARATE MALTODEXTRIN POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE 44;503" ], "ask_doctor": [ "Ask a doctor before use if liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® COLD MULTI-SYMPTOM SEVERE DAYTIME* Best Choice® Non-Drowsy Severe Multi-Symptom Cold DAYTIME ACETAMINOPHEN - Fever/Headache, Sore Throat Dextromethorphan HBr - Coughing Guaifenesin - Expectorant Phenylephrine HCl - Nasal Congestion Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant Pseudoephedrine Free 24 Cool Caplets with Cool Blast Flavor *This product is not manufactured or distributed by McNeil Consumer HealthCare, owner of the registered trademark Tylenol® Cold Multi-Symptom Severe Daytime . 50844 RREV0512C50308 PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO. KANSAS CITY, KS 66106 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Best Choice 44-503CMS Best Choice 44-503CMS" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms minor aches and pains headache nasal congestion sore throat impulse to cough cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever" ], "set_id": "1d0d5dd6-e8ab-4948-a5b9-a4a3332616ac", "id": "00c0b9aa-94d9-40c0-bde4-1cda4b12afb5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenyleprhine HCl 5 mg" ] }, { "effective_time": "20151123", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: WATER,JUNIPERUS COMMUNIS FRUIT EXTRACT,RUBUS COREANUS FRUIT EXTRACT,ADONIS AMURENSIS/AKEBIA QUINATA/ALBIZIA JULIBRISSIN/ALTHAEA ROSEA/ANGELICA ACUTILOBA/ANGELICA ANOMALA/AQUILEGIA BUERGERIANA/ARTEMISIA PRINCEPS/ASTER CILIOSUS/ASTER SCABER/BRASSICA CAMPESTRIS/BROUSSONETIA KAZINOKI/CALLISTEPHUS CHINENSIS/CAMELLIA JAPONICA/CAMELLIA SINENSIS/CAMPSIS GRANDIFLORA/CARAGANA SINICA/CARTHAMUSTINCTORIUS/CASSIA OBTUSIFOLIA/CELOSIA CRISTATA/CERCIS CHINENSIS/CHAENOMELES SINENSIS/CHRYSANTHEMUM INDICUM/CHRYSANTHEMUM ZAWADSKII/CLEMATIS TERNIFLORA/COMMELINA COMMUNIS/CORNUS KOUSA/CORNUS OFFICINALIS/CORYDALIS INCISA/CORYDALIS TURTSCHANINOVII/CUCURBITA MOSCHATE/DENDROBIUM NOBILE/DIANTHUS CHINENSIS/ELSHOLTZIA SPLENDENS/EUPATORIUM LINDLEYANUM/FORSYTHIA KOREANA/FRITILLARIA USSURIENSIS/GARDENIA JASMINOIDES/GINKGO BILOBA/HELIANTHUS ANNUUS/HELIANTHUS TUBEROSUS/HEMEROCALLIS FULVA/HIBISCUS MUTABILIS/HIBISCUS SYRIACUS/HOSTA PLANTAGINAE/HYDRANGEA MACROPHYLLA/IMPATIENS BALSAMINA/IPOMEA HEDERACEA/IRIS PALLASII/IRIS PSEUDACORUS/KERRIA JAPONICA/LAGERSTROEMIA INDICA/LEONURUS SIBIRICUS/LESPEDEZA BICOLOR/LILIUM LANCIFOLIUM/LINDERA OBTUSILOBA/LIRIOPES MUSCARI/LONICERA JAPONICA/LYCORIS RADIATA/MAGNOLIA KOBUS/MAGNOLIA LILIFLORA/MALUS SIEBOLDII/NARCISSUS TAZETTA/NELUMBO NUCIFERA/OENOTHERA BIENNIS/PAEONIA LACTIFLORA/PAEONIA SUFFRUTICOSA/PAPAVER RHOEAS/PATRINIA SCABIOSIFOLIA/PAULOWNIA COREANA/PERSICARIA THUNBERGII/PETASITES JAPONICUS/PHYTOLACCA ESCULENTA/PLATYCODON GRANDIFLORUS/POLYGONUM ODORATUM/PONICIRUS TRIFOLIATA/PRUNUS ARMENIACA/PRUNUS MUME/PRUNUS PERSICA/PRUNUS SERRULATA/PRUNUS TOMENTOSA/PUERARIA LOBATA/RHODODENDRON MUCRONULATUM/ROBINIA PSEUDACACIA/ROSA MULTIFLORA/ROSA RUGOSA/SASA BOREALIS/SOPHORA JAPONICA/SPIRAEA PRUNIFOLIA/STYRAX JAPONICA/SYRINGA VULGARIS/TARAXACUM PLATYCARPUM/TULIPA EDULIS/VIOLA MANDSCHURICA/WEIGELA SUBSESSILIS/WISTERIA SINENSIS/ZANTHOXYLUM SCHINIFOLIUM/ZEA MAYS/ZINGIBER MIOGA/ZINNIA ELEGANS FLOWER EXTRACT,MORUS NIGRA LEAF EXTRACT,PUNICA GRANATUM EXTRACT,EUTERPE OLERACEA FRUIT EXTRACT,SAMBUCUS NIGRA FRUIT EXTRACT,RUBUS CHAMAEMORUS SEED EXTRACT,LYCIUM BARBARUM FRUIT EXTRACT,VACCINIUM MYRTILLUS FRUIT EXTRACT,PRUNELLA VULGARIS EXTRACT,MITRACARPUS SCABER EXTRACT,ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT,FUCUS VESICULOSUS EXTRACT,CAESALPINIA SAPPAN BARK EXTRACT,POGOSTEMON CABLIN LEAF EXTRACT,MYRISTICA FRAGRANS (NUTMEG) EXTRACT,DRABA NEMOROSA EXTRACT,CORYDALIS OCHOTENSIS EXTRACT,RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT,CHENOPODIUM ALBUM FLOWER EXTRACT,VACCINIUM ANGUSTIFOLIUM (BLUEBERRY) FRUIT EXTRACT,MORUS ALBA ROOT EXTRACT,FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT,LACTUCA INDICA EXTRACT,SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT,LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT,PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT,COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT,PLANTAGO ASIATICA EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,PORTULACA OLERACEA EXTRACT,PUERARIA THUNBERGIANA ROOT EXTRACT,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,PAEONIA LACTIFLORA ROOT EXTRACT,CNIDIUM OFFICINALE ROOT EXTRACT,CODIUM FRAGILE EXTRACT,ULMUS DAVIDIANA ROOT EXTRACT,SALVIA MILTIORRHIZA FLOWER/LEAF/ROOT EXTRACT,EUCOMMIA ULMOIDES EXTRACT,CAULERPA LENTILLIFERA EXTRACT,PORIA COCOS EXTRACT,PANAX GINSENG ROOT EXTRACT,PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT,CITRUS LIMON (LEMON) FRUIT EXTRACT ,CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT,ACER SACCHARUM (SUGAR MAPLE) EXTRACT,RUBUS ELLIPITICUS ROOT EXTRACT,RUBUS FRUTICOSUS (BLACKBERRY) LEAF EXTRACT ,PEG-40 HYDROGENATED CASTOR OIL,ALOE BARBADENSIS LEAF JUICE,HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER,SOLUBLE COLLAGEN,SODIUM HYALURONATE,BUTYLENE GLYCOL,SODIUM CITRATE,CITRIC ACID,ETHYLHEXYLGLYCERIN,DISODIUM EDTA,ALCOHOL,LACTOBACILLUS FERMENT,ALLANTOIN,HYDROXYMETHOXYPHENYL PROPYLMETHYLMETHOXYBENZOFURAN,MALTODEXTRIN,CHLORHEXIDINE DIGLUCONATE,XANTHAN GUM,FRAGRANCE,PHENOXYETHANOL" ], "purpose": [ "PURPOSE Purpose: Skin Protectant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep away from the reach of children" ], "warnings": [ "WARNINGS Warnings: 1. Stop using the product immediately if any of following symptoms appears, and consult a dermatologist as continuing to use the product may worsen the symptoms. 1) Red spots, swelling, itching or irritations during use 2) If above symptoms appeared to the applied area due to direct sunlight 2. Do not use on areas with scars, eczema or dermatitis 3. Storage and handling precautions 1) Close the lid after use 2) Keep away from the reach of children 3) Avoid storing high/low temperature and direct sunlight 4. Precautions during use 1) Use only on the vulva 2) Do not use the product for a prolonged period of time 3) Be careful if the affected area or the surrounding area is dirty 4) Do not use on children under 3 years of age 5) Avoid using during pregnancy and prior to the delivery as it may get into the newborn’s eyes during delivery" ], "spl_product_data_elements": [ "Inner Beauty Cleansing Tissue GLYCERIN GLYCERIN GLYCERIN WATER JUNIPERUS COMMUNIS FRUIT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Dosage & Administration: Use moderate amount." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Image of package" ], "indications_and_usage": [ "INDICATIONS & USAGE Indications & Usage: Take one sheet and gently wipe. You can use it as bathroom tissue or after using bathroom tissue. *No separate cleansing needed after use. *Be sure to reattach the sticker after use to prevent dryness." ], "set_id": "1d14b698-0cdf-4f8f-b4cc-6f82f1fb01e7", "id": "a53ea205-e715-4613-b0f1-ce91b9c67929", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredient: GLYCERIN 6.0%" ] }, { "effective_time": "20121015", "inactive_ingredient": [ "Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and stearic acid" ], "purpose": [ "Pain Reliever, Fever Reducer, Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Warnings: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product Do not: • use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • use more than the recommended dose for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • when using this product do not exceed recommended dose. • 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product. Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever. Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland" ], "spl_product_data_elements": [ "Sinus Relief Headache Nasal Acetaminophen,Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN POVIDONE K30 STEARIC ACID CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 sky blue FR2 FR2" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Adults and children 12 years of age and older: • Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. • Children under 12 years : Consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding baby, ask a health professional before use." ], "package_label_principal_display_panel": [ "MM1 Sinus Relief Headache nasal" ], "indications_and_usage": [ "Uses: Temporarily: • relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure ,helps decongest sinus openings and passages • restores free breathing. Temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps" ], "set_id": "1d975dea-6135-4560-b62e-fa31109fd002", "id": "ae5d9540-a988-4072-9a46-b2bfcb4fd3a1", "active_ingredient": [ "Active Ingredients Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer Phenylephrine HCl 5 mg.............................Nasal Decongestant" ] }, { "effective_time": "20150129", "purpose": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or Comments? Call 1-800-ShopRite" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a heath care professional before use." ], "storage_and_handling": [ "Other information each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever" ], "set_id": "1e0d1d59-8856-4914-b4dd-9050ab8086a0", "id": "f11d78c0-2007-4c20-a664-7ebfca15d6e2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant Phenylephrine hydrochloride 10 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch." ], "warnings": [ "Warnings Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use in a child under 4 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a heath care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "ShopRite Nighttime Flu Plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride Acetaminophen Acetaminophen Diphenhydramine hydrochloride Diphenhydramine Phenylephrine hydrochloride Phenylephrine acesulfame potassium aspartame anhydrous citric acid D&C yellow no. 10 FD&C blue no. 1 FD&C red no. 40 maltodextrin anhydrous trisodium citrate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a sodium-restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "spl_unclassified_section": [ "Drug Facts", "Distributed By: Wakefern Food Corp. 5000 Riverside Drive Keasbey, NJ 08832" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use in a child under 4 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Packet Carton Compare to: Active Ingredients in Theraflu ® Nighttime Severe Cold & Cough See New Warnings Information & Directions ShopRite ® Nighttime FLU & SEVERE COLD & COUGH ACETAMINOPHEN Pain Reliever/Fever Reducer DIPHENHYDRAMINE HCl Antihistamine/Cough Suppressant PHENYLEPHRINE HCl Nasal Decongestant Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache, Fever Honey Lemon Infused with Chamomile & White Tea Flavor 6 PACKETS PRINCIPAL DISPLAY PANEL - 6 Packet Carton" ], "purpose_table": [ "
Active ingredients (in each packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg Nasal decongestant
" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Stearyl Alcohol C12-15 Alkyl Benzoate PPG-14 Butyl Ether Hydrogenated Castor Oil Fragrance (Parfum) Dimethicone Polyethylene Helianthus Annuus (Sunflower) Seed Oil Sodium Starch Octenylsuccinate Caprylic/Capric Triglyceride Maltodextrin Hydrolyzed Corn Starch Gelatin Cellulose Gum Silica BHT" ], "purpose": [ "Purpose anti-perspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE" ], "spl_product_data_elements": [ "Degree Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 DIMETHICONE STEARYL ALCOHOL C12-15 ALKYL BENZOATE PPG-14 BUTYL ETHER HYDROGENATED CASTOR OIL SUNFLOWER OIL MALTODEXTRIN STARCH, CORN GELATIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM BUTYLATED HYDROXYTOLUENE" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ▪ apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.6 oz Degree Fresh Energy 2.6 oz", "48 Hour Label 48 hour label" ], "indications_and_usage": [ "Uses ▪ reduces underarm wetness" ], "set_id": "1e167278-86fa-4fa7-a1aa-665b4b11db2e", "id": "b4a58efd-b7e8-4059-aaef-0ccf7d8559e3", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (18.2%)" ] }, { "effective_time": "20120305", "inactive_ingredient": [ "Inactive ingredients Water (Aqua), Cyclopentasiloxane, Phenyl Trimethicone, Dimethicone, Silica, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone Crosspolymer, PEG-10 Stearate, Glyceryl Stearate, Bambusa Arundinacea Stem Powder, Boron Nitride, Stearyl Dimethicone, Sodium Hyaluronate, Lens Esculenta (Lentil) Seed Extract, Alpha-Glucan Oligosaccharide, Polymnia Sonchifolia Root Juice, Maltodextrin, Lactibacillus, Laminaria Saccharina Extract, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Tocopheryl Acetate, Ascorbic Acid, Chitosan, Propyl Gallate, Polyurethane-40, Zinc Gluconate, Sodium PCA, Sodium Lactate, Sorbitol, Proline, Triethoxycaprylylsilane, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Xantha Gum, Disodium EDTA, Magnesium Aluminum Silicate, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Mica, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Titanium Dioxide, (CI 77891), Iron Oxides (CI77489, CI77491, CI 77492, CI77499)." ], "purpose": [ "Purpose Acne Treatment" ], "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 Whe n using this product, using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin, if this occurs, only one medication should be used unless directed by a physician, avoid contact with eyes. Stop use and ask a doctor if, using other topical acne medications Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Whe n using this product, using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin, if this occurs, only one medication should be used unless directed by a physician, avoid contact with eyes." ], "questions": [ "Questions or comments? 1.800.33.MURAD Murad.com" ], "spl_product_data_elements": [ "Skin Perfecting Primer Acne and Shine Control Salicylic Acid Salicylic Acid Salicylic Acid WATER CYCLOMETHICONE 5 PHENYL TRIMETHICONE DIMETHICONE SILICON DIOXIDE BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL PEG-100 STEARATE GLYCERYL MONOSTEARATE BAMBUSA ARUNDINACEA STEM BORON NITRIDE HYALURONATE SODIUM LENTIL .ALPHA.-GLUCAN OLIGOSACCHARIDE MALTODEXTRIN SACCHARINA LATISSIMA THALLUS PENTYLENE GLYCOL HYDROXYPHENYL PROPAMIDOBENZOIC ACID ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID PROPYL GALLATE ZINC GLUCONATE SODIUM PYRROLIDONE CARBOXYLATE SODIUM LACTATE SORBITOL PROLINE TRIETHOXYCAPRYLYLSILANE POLYETHYLENE GLYCOL 2000 HYDROGENATED CASTOR OIL XANTHAN GUM EDETATE DISODIUM MAGNESIUM ALUMINUM SILICATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE SODIUM HYDROXIDE MICA PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN TITANIUM DIOXIDE FERRIC OXIDE RED" ], "other_safety_information": [ "Other information Other information, store at room temperature, avoid high temperatures, protect from freezing, keep away from flame, fire and heat." ], "openfda": {}, "version": "30441", "dosage_and_administration": [ "Directions Apply a thin layer to face under or in place of foundation, if bothersome dryness or peeling occurs, reduce application to every other day. Every day after moisturizing, blend evenly over face and neck." ], "stop_use": [ "Stop use and ask a doctor if, using other topical acne medications" ], "spl_unclassified_section": [ "image of bottle" ], "package_label_principal_display_panel": [ "image of carton" ], "indications_and_usage": [ "Use For the management of acne" ], "set_id": "1ebfa60f-b35d-4df9-9ec9-cbcc03f7b182", "id": "4fa9da28-5e15-42ad-a4c1-195f32faf1f6", "active_ingredient": [ "Active ingredients Salicylic Acid 0.5%" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Nighttime Inactive Ingredient Acesulfame potassium, Aspartame, Caramel, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.", "Multi-Symptom Inactive Ingredient Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, Silicon dioxide, Sodium Citrate, Starch and Sucrose." ], "purpose": [ "Purpose Nighttime Uses - temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever.", "Purpose Multi-Symptom Uses - Temporarily relieves these symptoms due to a cold: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - Temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Nighttime Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin reddening - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Multi-Symptom Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include - skin redenning - blisters - rash. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Well at Walgreens Multi-Symptom Wal-Flu Severe Cold and Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr Walgreens Nighttime Wal-Flu Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon flavor Caramel color D and C Yellow 10 Walgreens Multi-Symptom Wal-Flu Severe Cold Green Tea and Honey Lemon Flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey and Lemon flavor Natural Honey and Lemon Flavor Caramel color D and C Yellow No. 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Nighttime Dosage and Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and older one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve content of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.", "Multi-Symptom Dosage & Administration Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - do not use more than directed. - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. - a sodium restricted diet. Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Do not use - In a child under 4 years of age. - If you are allergic to Acetaminophen. - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "information_for_patients": [ "Nighttime Information for Patients Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.", "Multi-Symptom Information for Patients Other information - each packet contains: potassium 8 mg, sodium 15 mg, calcium 120 mg. - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1. jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "set_id": "1f336dce-df94-4c93-b901-17efc0b899d7", "id": "267ace69-bb22-482f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product - do not exceed recommended dosage. Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active Ingredients for Nighttime Wal-Flu Severe Cold and Cough Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.", "Active Ingredients for Multi-Symptom Wal-Flu Severe Cold Active ingredients (in each packet) Purpose Acetaminophen 500 mg ........................................Pain reliever/Fever reducer Dextromethorphan hydrobromide 20 mg ..............Cough suppressant Phenylephrine hydrochloride 10 mg.......................Nasal decongestant." ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and older one packet
", "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ] }, { "effective_time": "20121015", "inactive_ingredient": [ "Inactive ingredients: FDC Red 40, Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid" ], "purpose": [ "Pain Reliever, Fever Reducer, Antihistamine, Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "Warnings: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product Do not: use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • use more than the recommended dose • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product. Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland • may cause excitability especially in children • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect • avoid alcoholic beverages while taking this product • do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor • use caution when operating machinery." ], "spl_product_data_elements": [ "Allergy Relief Multisymptom Acetaminophen,Chlorpheniramine Maleate, Phenylephrine HCl POVIDONE K29/32 SODIUM STARCH GLYCOLATE TYPE A POTATO CELLULOSE, MICROCRYSTALLINE STEARIC ACID MALTODEXTRIN STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE snow white FR11 FR11" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Adults and children 12 years of age and older • take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor • Children under 12 years, consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding baby, ask a health professional before use." ], "package_label_principal_display_panel": [ "MM1 allergy multi symptom packet" ], "indications_and_usage": [ "Uses: Temporarily: • relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores free breathing • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive • Temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps" ], "set_id": "1fdea263-7769-4fb4-af81-58d902e49080", "id": "20ec419a-7112-4ba7-a0ec-da4dc0100e39", "active_ingredient": [ "Active Ingredients Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer Chlorpheniramine Maleate 2 mg.............................Antihistamine Phenylephrine HCl 5 mg.............................Nasal Decongestant" ] }, { "effective_time": "20121111", "inactive_ingredient": [ "Inactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid" ], "purpose": [ "Purpose: Pain Reliever / Fever Reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warning: Liiver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product" ], "spl_product_data_elements": [ "CETAFEN EXTRA acetaminophen ACETAMINOPHEN ACETAMINOPHEN HYDROXYPROPYL METHYLCELLULOSE E5 [II] MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL POVIDONE STEARIC ACID CFNX" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: do not take more than directed Adults and children 12 years of age and over: take 2 caplets every 4 to 6 hours while symptoms persist do not take more than 8 caplets in 24 hours unless directed by a doctor Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) for children under 12 years of age and may cause liver damage." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "stop_use": [ "Stop use and ask a doctor if new symptms occur redness or swelling is present fever worsens or lasts more than 3 days pain worsens or lasts more than 10 days These could be signs of a serious condition" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or non-prescription)" ], "package_label_principal_display_panel": [ "CetafenExtra.jpg" ], "indications_and_usage": [ "Uses: Temporarily relieves minor aches and pains due to: headache muscular aches backache minor arthritis pain the common cold toothache menstrual cramps Temporarily reduces fever" ], "set_id": "207cf327-b35c-405c-979e-af25183e6ae5", "id": "be810cb9-d7f4-481a-808f-527c3a157b29", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin you do not know if other drugs you are taking contain acetaminophen" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222." ], "active_ingredient": [ "Active Ingredient (in each caplet): Acetaminophen 500mg" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, maltodextrin*, methylparaben, microcrystalline cellulose, polyethylene glyocol, polyvinyl lacohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide *may also contain this ingredient" ], "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 immediately." ], "warnings": [ "Warnings Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are taking a presciption drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs When using this product do not use for a period longer than 1 week Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product do not use for a period longer than 1 week" ], "spl_product_data_elements": [ "Maximum Strength Laxative Sennosides SENNOSIDES SENNOSIDES ACACIA CALCIUM CARBONATE CARNAUBA WAX CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 MAGNESIUM STEARATE MALTODEXTRIN METHYLPARABEN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL PROPYLENE GLYCOL PROPYLPARABEN SHELLAC SODIUM BENZOATE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE 44;348" ], "ask_doctor": [ "Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions swallow pill(s) with a glass of water swallow pill(s) whole, do not crush, break or chew adults and children 12 years of age and older 2 pills once or twice daily children 6 to under 12 years of age 1 pill once or twice daily 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 rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition." ], "storage_and_handling": [ "Other information each pill contains: calcium 20 mg store at controlled room temperature 15º to 30ºC (59º-86ºF) see end flag for expiration date and lot number for better identification keep pills in carton until used" ], "do_not_use": [ "Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel For Gentle, Dependable Overnight Relief Compare to the Active Ingredient of Maximum Strength ex•lax®† Our Family® Quality Care Since 1904 Maximum Strength LAXATIVE PILLS Sennosides USP, 25 mg STIMULANT LAXATIVES 24 PILLS †This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Maximum Strength ex•lax®. DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS, 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF16338 50844 REV0410B34808 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Our Family 44-348 Our Family 44-348" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours" ], "set_id": "211de64e-7601-4a2e-975c-17d3812e7385", "id": "7bc06a63-4b47-4fbd-8507-ee63e859d930", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a presciption drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs" ], "active_ingredient": [ "Active ingredient (in each pill) Sennosides USP, 25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and older 2 pills once or twice daily
children 6 to under 12 years of age 1 pill once or twice daily
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20120822", "inactive_ingredient": [ "Inactive ingredients crospovidone, D&C Red No 7 calcium lake, ethyl cellulose, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium polystyrene sulfonate, sodium starch glycolate, sucralose" ], "purpose": [ "Purpose Nighttime Sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a poison center (1-800-222-1222) right away" ], "warnings": [ "Warnings Do not use For children under 12 years of age With any other product containing Diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers While using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 center (1-800-222-1222) right away" ], "when_using": [ "While using this product avoid alcoholic drinks" ], "questions": [ "Question or comments? Call toll free 1--800-walgreens" ], "spl_product_data_elements": [ "Wal-Som Diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSPOVIDONE D&C RED NO. 7 ETHYLCELLULOSES MAGNESIUM STEARATE MALTODEXTRIN MANNITOL CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM POLYSTYRENE SULFONATE SODIUM STARCH GLYCOLATE TYPE A POTATO SUCRALOSE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) Cherry flavor Round lozenge shaped CP223 pink color" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years of age and over: 2 Rapidmelt (25mg each) at bedtime if needed, or as directed by a doctor Place 2 tablets on to tongue; tablets dissolve with or without water allow tablets to dissolve in mouth or chew before swallowing" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness." ], "spl_unclassified_section": [ "Other information Each tablet contains Sodium 5mg Do not use if carton is opened or blister unit is broken Store between 20-25 ° C(68-77 ° F ). Avoid high humidity. Protect from light. See side panel for lot number and expiration date" ], "do_not_use": [ "Do not use For children under 12 years of age With any other product containing Diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal display panel NEW QUICK DISSOLVING NIGHTTIME SLEEP AID WELL AT WALGREENS WALGREENS PHARMACIST RECOMMENDED WAL-SOM DIPHENHYDRAMINE HCL TABLETS 25MG RAPIDMELT/ SLEEP AID SAFE, NON-HABIT FORMING, FALL ASLEEP FASTER, SLEEP SOUNDLY, WAKE UP REFRESHED 24 QUICK DISSOLVING TABLETS COMPARE TO UNISOM SLEEPMELTS ACTIVE INGREDIENT DO NOT SWALLOW WHOLE TABLET Carton image" ], "indications_and_usage": [ "Uses For relief of occasional sleeplessness" ], "set_id": "21f18921-e0d7-42ad-8a62-e912711aa8a3", "id": "14c0e8e3-f36f-4b10-8f76-2079600ca6f4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient Diphenhydramine HCl 25mg" ] }, { "effective_time": "20141222", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid, talc*, titanium dioxide, triglycerides* *contains one or more of these ingredients" ], "purpose": [ "Purpose Stool softener 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 laxative products for longer than 1 week unless told 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 or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call toll free 1-877-932-7948" ], "spl_product_data_elements": [ "Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES CARNAUBA WAX CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED WATER SODIUM BENZOATE STEARIC ACID TITANIUM DIOXIDE C10-18 TRIGLYCERIDES SILICON DIOXIDE ALUMINUM OXIDE TCL097;SS2;S44" ], "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": "3", "dosage_and_administration": [ "Directions Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 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." ], "storage_and_handling": [ "Other information each tablet contains: calcium 20 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 15º-30ºC (59º-86ºF), protect from excessive moisture" ], "do_not_use": [ "Do not use laxative products for longer than 1 week unless told 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 COMPARE TO PERI-COLACE® ACTIVE INGREDIENTS† Stool Softener Plus Stimulant Laxative Docusate Sodium 50 mg/ Sennosides 8.6 mg For Overnight Relief of Occasional Constipation Effective, Reliable, Comfortable Tablets †This product is not manufactured or distributed Purdue Products L.P., owner of the registered trademark Peri-Colace® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA Contact us at 1-877-932-7948 or www.supervalu-ourownbrands.com", "Product Label Stool softener plus stimulant laxative Equaline" ], "indications_and_usage": [ "Uses for overnight relief from occasional constipation (irregularity) generally produces a bowel movement in 6 to 12 hours" ], "set_id": "21f8ea1e-38fe-4c93-854e-6cff16a0f2d3", "id": "6c5cfe49-5cc8-4800-acb9-5105ec0d941a", "active_ingredient": [ "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 ask a doctor
" ] }, { "effective_time": "20130731", "inactive_ingredient": [ "Inactive ingredients corn starch, corn syrup, corn syrup solids, FD&C red #40, flavoring, glycerin, hydrogenated coconut oil, maltodextrin, sorbitol, soy lecithin, soy protein, sucrose, and titanium dioxide" ], "purpose": [ "Active ingredients (in each chew) Purpose Calcium carbonate 1177 mg Antacid Simethicone 80 mg Antigas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 6 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Keep out of reach of children." ], "when_using": [ "Do not take more than 6 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician." ], "questions": [ "Questions? call 1-800-223-0182" ], "spl_product_data_elements": [ "Rolaids Plus Calcium Carbonate and Dimethicone Calcium Carbonate Carbonate ion Dimethicone Dimethicone starch, corn corn syrup FD&C red no. 40 glycerin hydrogenated coconut oil maltodextrin sorbitol lecithin, soybean soy protein sucrose titanium dioxide Off white to Tan Cube Tropical Fruit" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew and swallow 2 to 3 chews, hourly if needed" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other information each chew contains: calcium 510 mg, magnesium 5 mg, sodium 2 mg contains soy store between 20 - 25° C (68 - 77° F) in a dry place tamper evident statement see back panel for lot number and expiration date" ], "active_ingredient_table": [ "
Active ingredients (in each chew) Purpose
Calcium carbonate 1177 mg Antacid
Simethicone 80 mg Antigas
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "indications_and_usage": [ "Uses relieves: heartburn sour stomach acid indigestion upset stomach due to these symptoms bloating, pressure, and discomfort commonly referred to as gas" ], "set_id": "22d9b22a-e438-4158-890a-2d03506ac6f0", "id": "b481a7a3-3deb-4ea9-ab10-4ffda70fbfd5", "purpose_table": [ "
Active ingredients (in each chew) Purpose
Calcium carbonate 1177 mg Antacid
Simethicone 80 mg Antigas
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each chew) Purpose Calcium carbonate 1177 mg Antacid Simethicone 80 mg Antigas" ] }, { "effective_time": "20120823", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestion" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "spl_product_data_elements": [ "Severe Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE TITANIUM DIOXIDE 44;503" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 11673-503-08 severe cold relief non-drowsy acetaminophen, 325 mg dextromethorphan HBr, 10 mg guaifenesin, 200 mg phenylephrine HCl, 5 mg Compare to active ingredients in Tylenol® Cold Multi-Symptom Severe Daytime Caplets pain reliever, fever reducer, nasal decongestant, cough suppressant, expectorant for ages 12 and older, with cool-blast sensation up to 4 hours relief does not contain pseudoephedrine up & up ™ DAY 24 CAPLETS 24 CAPLETS SHOWN ACTUAL SIZE ABOVE TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0111B50308 094 14 0202 ID201455 Distributed by Target Corporation, Mpls., MN 55403 © 2012 Target Brands, Inc. All Rights Reserved Shop Target.com Target 44-503C Target 44-503C" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms: headache minor aches and pains sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever" ], "set_id": "23f26480-233c-4d7a-9164-e296098efcb5", "id": "23dae1d6-8748-42c8-b277-acf81e92350b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20151210", "inactive_ingredient": [ "Inactive Ingredients: Acesulfame Potassium, Citric Acid, FD and C Yellow No. 5, Flavors, Maltitol, Maltodextrin, Menthol, Silicon Dioxide, Sucralose. Contains: FD and C Yellow No. 5 (tartrazine) as a color additive." ], "purpose": [ "Purpose Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contract a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount for this product - 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, nausea or vomiting, consult a doctor promptly. Do Not Use To Sedate Children. Do Not Use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients. in children under 12 years Ask a doctor before use if you have: - liver disease, - hear disease, - high blood pressure, - thyroid disease, - diabetes, - glaucoma, - cough with excessive phlegm (mucus), - a breathing problem such as emphysema or chronic bronchitis, - difficulty in urination due to enlargement of prostate gland, - persistent or chronic cough such as occurs with smoking, asthma and emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contract a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operating machinery excitability may occur, especially in children" ], "spl_product_data_elements": [ "SMITH BROS NIGHT TIME COUGH and CONGESTION ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 5 MALTITOL MALTODEXTRIN MENTHOL SILICON DIOXIDE SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Honey Chamomile" ], "ask_doctor": [ "Ask a doctor before use if you have: - liver disease, - hear disease, - high blood pressure, - thyroid disease, - diabetes, - glaucoma, - cough with excessive phlegm (mucus), - a breathing problem such as emphysema or chronic bronchitis, - difficulty in urination due to enlargement of prostate gland, - persistent or chronic cough such as occurs with smoking, asthma and emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than recommended dose take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. AGE DOSE children under 12 years do not use adults and children 12 years and over one packet dissolve 1 packet into 8oz. of hot water; sip while hot. Consume entire drink within 10 minutes." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "SMITH BROS NIGHT TIME COUGH & CONGESTION", "Other Information each packet contains: 15 calories store at room temperature. Avoid excessive heat. Tamper Evident . Do not use if packet has been disturbed or torn." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do Not Use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients. in children under 12 years" ], "package_label_principal_display_panel": [ "PRODUCT LABELS Night Time" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to a cold: minor aches and pains headache nasal congestion sinus congestion and pressure cough sore throat sneezing runny nose temporarily reduces fever" ], "set_id": "241a2c3e-731b-4f7c-8343-f8dd6c2cd03b", "id": "269247d2-8b74-34da-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan Hydrobromide 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCl 10 mg Purpose Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant" ], "dosage_and_administration_table": [ "
AGE DOSE
children under 12 years do not use
adults and children 12 years and over one packet
" ] }, { "effective_time": "20151110", "precautions": [ "PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "purpose": [ "Purpose Skin Protectant" ], "description": [ "DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure" ], "general_precautions": [ "General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled." ], "storage_and_handling": [ "Other information ■ protect from freezing ■ avoid excessive heat" ], "indications_and_usage": [ "INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.", "Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin" ], "set_id": "24664e10-3424-6186-e054-00144ff88e88", "id": "24381bab-d419-035b-e054-00144ff88e88", "active_ingredient": [ "Active ingredient Dimethicone 5.0%" ], "pediatric_use": [ "Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "inactive_ingredient": [ "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine." ], "contraindications": [ "CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation." ], "pregnancy": [ "Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time." ], "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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "nursing_mothers": [ "Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman." ], "spl_product_data_elements": [ "NEWSDS pak Triamcinolone Acetonide Cream, Dimethicone Cream Triamcinolone Acetonide Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Skin Repair Complex Dimethicone KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE DIMETHICONE DIMETHICONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ apply cream liberally as needed" ], "adverse_reactions": [ "ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria" ], "spl_unclassified_section": [ "Triamcinolone Acetonide Cream USP (0.1%) DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 0603-7862-90 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.", "Skin Repair Complex (Dimethicone 5.0%) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin 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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions ■ apply cream liberally as needed Other information ■ protect from freezing ■ avoid excessive heat Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.", "Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours." ], "laboratory_tests": [ "Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test" ], "how_supplied": [ "HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 0603-7862-90 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION." ], "information_for_patients": [ "Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings." ], "package_label_principal_display_panel": [ "NEWSDS pak- carton new_sds_pak" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results." ], "overdosage": [ "DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted." ] }, { "effective_time": "20151113", "precautions": [ "PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "purpose": [ "Purpose Skin Protectant" ], "description": [ "DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure" ], "general_precautions": [ "General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled." ], "storage_and_handling": [ "Other information ■ protect from freezing ■ avoid excessive heat" ], "indications_and_usage": [ "INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.", "Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin" ], "set_id": "24749639-0fa6-6a6c-e054-00144ff88e88", "id": "2474660b-176c-63aa-e054-00144ff88e88", "active_ingredient": [ "Active ingredient Dimethicone 5.0%" ], "pediatric_use": [ "Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children." ], "inactive_ingredient": [ "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine." ], "contraindications": [ "CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation." ], "pregnancy": [ "Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time." ], "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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "nursing_mothers": [ "Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman." ], "spl_product_data_elements": [ "NEWSDS pak Triamcinolone Acetonide Cream, Dimethicone Cream Triamcinolone Acetonide Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE Skin Repair Complex Dimethicone KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE DIMETHICONE DIMETHICONE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ■ apply cream liberally as needed" ], "adverse_reactions": [ "ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria" ], "spl_unclassified_section": [ "Triamcinolone Acetonide Cream USP (0.1%) DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. structure CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. INDICATIONS AND USAGE Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-PEDIATRIC USE). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are not adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin Atrophy Striae Miliaria DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 0603-7862-90 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.", "Skin Repair Complex (Dimethicone 5.0%) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin 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 ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions ■ apply cream liberally as needed Other information ■ protect from freezing ■ avoid excessive heat Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.", "Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours." ], "laboratory_tests": [ "Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test" ], "how_supplied": [ "HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 0603-7862-90 Store at 59-86°F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION." ], "information_for_patients": [ "Information for the Patient Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings." ], "package_label_principal_display_panel": [ "NEWSDS pak- carton new_sds_pak" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteriods are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results." ], "overdosage": [ "DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted." ] }, { "effective_time": "20131030", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Tropical Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "2.6 oz PDP DegreeMSTropicalRushPDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "24d3ea41-803a-4e78-b42d-8157e74b28e6", "id": "bc826efa-82b3-4ee6-b5a7-94c0f694ffb2", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20151217", "purpose": [ "Purposes Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product • do not exceed recommended dosage • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-877-932-7948" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information • each packet contains: potassium 10 mg and sodium 25 mg • phenylketonurics: contains phenylalanine 13 mg per packet • store at 20-25°C (68-77°F)" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • runny nose • sneezing • itchy nose or throat • itchy, watery eyes due to hay fever • cough due to minor throat and bronchial irritation • temporarily reduces fever" ], "set_id": "26112a21-f2c3-4021-898b-a86d357a0a91", "id": "773eb167-6652-40fd-a664-9d5de77b233d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg" ], "dosage_and_administration_table": [ "
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over one packet
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "spl_product_data_elements": [ "equaline flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME SILICON DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SODIUM CITRATE SUCROSE TRIBASIC CALCIUM PHOSPHATE Light to dark" ], "ask_doctor": [ "Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "stop_use": [ "Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion gets worse or lasts more than 7 days • cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use • if you have ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing diphenhydramine, even one used on skin • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel compare to Theraflu® Nighttime Severe Cold & Cough active ingredients flu & severe cold & cough nighttime acetaminophen (pain reliever/fever reducer) diphenhydramine HCl (antihistamine/cough suppressant) phenylephrine HCl (nasal decongestant) relieves: nasal congestion cough runny nose sneezing body ache sore throat pain headache/fever SEE NEW WARNINGS honey lemon infused with white tea flavors 6 packets Equaline Flu & Severe Cold & Cough image 1 Equaline Flu & Severe Cold & Cough image 2" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.", "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine" ], "contraindications": [ "CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components." ], "precautions": [ "PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Mupirocin Ointment USP, 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - *Bactroban Nasal ® (mupirocin calcium ointment) – is available for intranasal use. Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Mupirocin Ointment USP, 2% should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. Information for Patients - Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner. Drug Interactions - The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice. Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin. Pregnancy: Teratogenic Effects - Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman. Pediatric Use - The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years. Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled studies of mupirocin ointment USP, 2% in impetigo in pediatric patients studied as part of the pivotal clinical trials (see CLINICAL STUDIES )." ], "purpose": [ "Purpose Antiseptic", "Purpose Skin Protectant" ], "warnings": [ "WARNINGS Mupirocin Ointment USP, 2% is not for ophthalmic use.", "Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. 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 deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Dermawerx Surgical Plus Pak Mupirocin Ointment Kit Mupirocin Mupirocin POLYETHYLENE GLYCOLS MUPIROCIN MUPIROCIN Antiseptic Skin Cleanser Chlorhexidine Gluconate COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN CHLORHEXIDINE GLUCONATE CHLORHEXIDINE Skin Repair Complex Dimethicone BUTYLENE GLYCOL SAFFLOWER OIL CETYL ALCOHOL KUKUI NUT OIL ALOE VERA LEAF CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE TROLAMINE STEARIC ACID HYALURONATE SODIUM PHENOXYETHANOL NIACINAMIDE GINGER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PEG-100 STEARATE .ALPHA.-TOCOPHEROL ACETATE, DL- CAPRYLYL GLYCOL METHYLPARABEN WATER DIMETHICONE DIMETHICONE" ], "description": [ "DESCRIPTION Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E )-(2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26 H 44 O 9 and the molecular weight is 500.62. The chemical structure is: image description" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.", "Directions use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly", "Directions gently cleanse and dry affected area apply liberally to affected area as needed." ], "adverse_reactions": [ "ADVERSE REACTIONS The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: Burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to mupirocin ointment USP, 2% have occurred rarely." ], "spl_unclassified_section": [ "Mupirocin Ointment USP, 2% For Dermatologic Use Rx Only DESCRIPTION Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E )-(2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26 H 44 O 9 and the molecular weight is 500.62. The chemical structure is: image description CLINICAL PHARMACOLOGY Application of 14 C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency. Microbiology - Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens . It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents. Resistance occurs rarely. However, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci. Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined. Mupirocin has been shown to be active against most strains of S. aureus and Streptococcus pyogenes , both in vitro and in clinical studies (see INDICATIONS AND USAGE ). The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus . INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes . CONTRAINDICATIONS This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. WARNINGS Mupirocin Ointment USP, 2% is not for ophthalmic use. PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Mupirocin Ointment USP, 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - *Bactroban Nasal ® (mupirocin calcium ointment) – is available for intranasal use. Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Mupirocin Ointment USP, 2% should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. Information for Patients - Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner. Drug Interactions - The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted. Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice. Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin. Pregnancy: Teratogenic Effects - Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman. Pediatric Use - The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years. Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled studies of mupirocin ointment USP, 2% in impetigo in pediatric patients studied as part of the pivotal clinical trials (see CLINICAL STUDIES ). ADVERSE REACTIONS The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: Burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to mupirocin ointment USP, 2% have occurred rarely. DOSAGE AND ADMINISTRATION A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. CLINICAL STUDIES The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo three times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second study, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% three times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment. Pediatrics - There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric patients was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%). HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 45802-112-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal ® is a registered trademark of GlaxoSmithKline.", "Chlorhexidine Gluconate Solution, 4% Drug Facts Active ingredient Chlorhexidine Gluconate 4% solution Purpose Antiseptic Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. Directions use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF) Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.", "Skin Repair Cream (5% Dimethicone) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses temporarily protects and helps relieve chapped or cracked skin 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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions gently cleanse and dry affected area apply liberally to affected area as needed. Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine", "Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours." ], "storage_and_handling": [ "Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)" ], "how_supplied": [ "HOW SUPPLIED Mupirocin Ointment USP, 2% is available as follows: 22 gram tube (NDC 45802-112-22) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. *Bactroban Nasal ® is a registered trademark of GlaxoSmithKline." ], "clinical_studies": [ "CLINICAL STUDIES The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo three times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second study, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% three times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment. Pediatrics - There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric patients was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%)." ], "package_label_principal_display_panel": [ "Dermawerx Surgical Plus Pak surgical_pak" ], "indications_and_usage": [ "INDICATIONS AND USAGE Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes .", "Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing", "Uses temporarily protects and helps relieve chapped or cracked skin" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Application of 14 C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application. Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency. Microbiology - Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens . It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents. Resistance occurs rarely. However, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci. Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined. Mupirocin has been shown to be active against most strains of S. aureus and Streptococcus pyogenes , both in vitro and in clinical studies (see INDICATIONS AND USAGE ). The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus ." ], "set_id": "268023e4-43f0-3d4c-e054-00144ff8d46c", "id": "268023e4-43f1-3d4c-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient Chlorhexidine Gluconate 4% solution", "Active ingredient Dimethicone 5.0%" ] }, { "effective_time": "20151210", "inactive_ingredient": [ "Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.", "Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine" ], "purpose": [ "Purpose Antiseptic", "Purpose Skin Protectant" ], "warnings": [ "Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. 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 deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Dermawerx Surgical PrePak chlorhexidine gluconate pre-surgical kit Antiseptic Skin Cleanser Chlorhexidine Gluconate GLUCONOLACTONE PEG-75 LANOLIN CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL Skin Repair Complex Dimethicone BUTYLENE GLYCOL SAFFLOWER OIL CETYL ALCOHOL KUKUI NUT OIL ALOE VERA LEAF CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE TROLAMINE STEARIC ACID HYALURONATE SODIUM PHENOXYETHANOL NIACINAMIDE GINGER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PEG-100 STEARATE .ALPHA.-TOCOPHEROL ACETATE, DL- CAPRYLYL GLYCOL METHYLPARABEN WATER DIMETHICONE DIMETHICONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly", "Directions gently cleanse and dry affected area apply liberally to affected area as needed." ], "spl_unclassified_section": [ "Chlorhexidine Gluconate Solution, 4% Drug Facts Active ingredient Chlorhexidine Gluconate 4% solution Purpose Antiseptic Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away. Directions use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF) Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.", "Skin Repair Cream (5% Dimethicone) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses temporarily protects and helps relieve chapped or cracked skin 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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions gently cleanse and dry affected area apply liberally to affected area as needed. Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine", "Silicone Tape Uses • To be applied to wounds or scars as a protective silicone barrier. • As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. • As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions • Do not use if you are allergic to silicone • Keep out of reach of children Directions for use • Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours." ], "storage_and_handling": [ "Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF)" ], "package_label_principal_display_panel": [ "Dermawerx Surgical Pre Pak Surgical_Pre_pak" ], "indications_and_usage": [ "Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing", "Uses temporarily protects and helps relieve chapped or cracked skin" ], "set_id": "2687330c-50dc-0339-e054-00144ff88e88", "id": "2687330c-50dd-0339-e054-00144ff88e88", "active_ingredient": [ "Active ingredient Chlorhexidine Gluconate 4% solution", "Active ingredient Dimethicone 5.0%" ] }, { "effective_time": "20120926", "inactive_ingredient": [ "Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid. image of display" ], "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 Center immediately." ], "warnings": [ "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": [ "Leader TabTussin DM TDM Dextromethorphan Hydrobromide / Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Guaifenesin Guaifenesin SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN STEARIC ACID PH073" ], "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 (mucus)" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, 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." ], "storage_and_handling": [ "Other Information Store at 15°-30°C (59°-86°F)" ], "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": "277ef76d-62f1-4114-b229-b0d2570366e1", "id": "fe8524f9-e17b-4a00-9fed-7fae48734deb", "active_ingredient": [ "Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg" ] }, { "effective_time": "20120730", "inactive_ingredient": [ "Inactive Ingredients Water (Aqua) Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Methyl Gluceth-20, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Butylene Glycol, Cimicifuga Racemosa Root Extract, Camellia Oleifera Leaf Extract, Silver Citrate, Menthol, PEG-150 Distearate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Corn Starch Octenylsuccinate, Glyceryl Stearate, Cocamidopropyl Dimethylamine, Polysorbate 80, Citric Acid, Tetrasodium EDTA, Chlorphenesin, Methylisothiazolinone, Limonene, Citrus Reticulata (Tangerine) Leaf Oil, Cybopogon nardus (Citronella) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Aurantifolia (Lime) Oil, Lavandula Hybrida Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Prunus Armeniaca (Apricot) Kernel Oil, Fragrance (Parfum).", "Inactive ingredients Water (Aqua), Alcohol denatured, Butylene Glycol, Glycolic Acid, Methyl Gluceth-10, PPF-5-Ceteth-20, Aloe Barbadensis Leaf Juice, Hydrogen Peroxide, Rice Amino Acids, Zinc Aspartate, Ascorbic Acid, Chitosan, Retinol, Polysorbate 20, Arnica Montana Flower Extract, Epilobium Angustifolium Flower.Leaf/Stem Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Lecithin, Tocopherol, Magnesium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Water, Zinc Acetate, Linoleic Acid, Sodium Hydroxide, Propyl Gallate, Disodium EDTA, Hydroxyethylcellulose, Tetrasodium EDTA.", "Inactive ingredients Water (Aqua), Glycolic Acid, Sclerotium Gum, Dicaprylyl Maleate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate,Ceteareth-20, Glycerin, Avena sativa (Oat) Kernel Extract, Zinc Acetate, Salicylic Acid, Lecithin, Tocopherol, Magnesium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosppolymer, Vitis Vinifera (Grape) Seed Extract, Allantoin, Sodium Hydroxide, Disodium EDTA, Diazolidinyl Urea, Metylparaben, Propylparaben, Limonene, Citrus Aurantium Dulcis (Orange) Peel Oil.", "Inactive ingredients Water (Aqua), Kaolin, Bentonite, Propylene Glycol, Glycerin, Glyceryl Sterate SE, Zinc Oxide, Talc, Titanium Dioxide, Cetyl Alcohol, Dicaprylyl Maleate, Salicylic Acid, Lecithin, Tocoherol, Magnesium Ascorbyl Phosphate, Palmitoyl Hydroxyprpyltrimonium Amylopectin/Glycrin Crosspolymer, Vitis Vinifera (Grape) Seed Extract, Dipotassium Glycyrrhizate, Allantoin, Tetrasodium EDTA, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Diazolidinyl Urea, Methylchloroisothiazolinone, Methylisothiazolinone, Camphor, Geraniol, Limonene, Linalool, Lavandula Angustifolia (Lavender) Oil.", "Inactive ingredients Water (Aqua), Cyclopentasiloxane, Phenyl Trimethicone, Dimethicone, Silica, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone Crosspolymer, PEG-10 Stearate, Glyceryl Stearate, Bambusa Arundinacea Stem Powder, Boron Nitride, Stearyl Dimethicone, Sodium Hyaluronate, Lens Esculenta (Lentil) Seed Extract, Alpha-Glucan Oligosaccharide, Polymnia Sonchifolia Root Juice, Maltodextrin, Lactibacillus, Laminaria Saccharina Extract, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Tocopheryl Acetate, Ascorbic Acid, Chitosan, Propyl Gallate, Polyurethane-40, Zinc Gluconate, Sodium PCA, Sodium Lactate, Sorbitol, Proline, Triethoxycaprylylsilane, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Xantha Gum, Disodium EDTA, Magnesium Aluminum Silicate, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Mica, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Titanium Dioxide, (CI 77891), Iron Oxides (CI77489, CI77491, CI 77492, CI77499)." ], "purpose": [ "Purpose Acne Treatment", "Purpose Acne Treatment", "Purpose Acne Treatment", "Purpose Acne Treatment", "Purpose Acne Tretament" ], "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.", "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only When using this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a physician, avoid contact with eyes. Stop use and ask a doctor if, skin rash occurs. 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 this product, using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a physician, avoid contact with eyes. Stop use and ask a doctor if, skin rash occurs 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 this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician. Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a physician. Stop use and ask a doctor if, skin rash occurs. 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 this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician. Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a physician. Stop use and ask a doctor i f skin rash occurs. 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 this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin, if this occurs, only one medication should be used unless directed by a physician, avoid contact with eyes. Stop use and ask a doctor if , using other topical acne medications 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 , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a physician, avoid contact with eyes.", "When using this product, using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a physician, avoid contact with eyes.", "When using this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician. Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a physician.", "When using this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a physician. Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a physician.", "When using this product , using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin, if this occurs, only one medication should be used unless directed by a physician, avoid contact with eyes." ], "questions": [ "Questions or comments? 888.88.MURAD Murad.com", "Questions or comments? 888.88.MURAD Murad.com", "Questions or comments? 888.88.MURAD Murad.com", "Questions or comments? 888.88.MURAD Murad.com", "Questions or comments? 1.800.33.MURAD Murad.com" ], "spl_product_data_elements": [ "Acne 60 Day Salicylic Acid, Salicylic Acid, Sulfur, Sulfur, Salicylic Acid Clarifying Cleanser Salicylic Acid Salicylic Acid Salicylic Acid WATER COCAMIDOPROPYL BETAINE SODIUM C14-16 OLEFIN SULFONATE METHYL GLUCETH-20 POLYOXYL 40 HYDROGENATED CASTOR OIL BUTYLENE GLYCOL BLACK COHOSH CAMELLIA OLEIFERA LEAF SILVER CITRATE MENTHOL PEG-150 DISTEARATE STARCH, CORN GLYCERYL MONOSTEARATE DIMETHICONE CITRIC ACID MONOHYDRATE POLYSORBATE 80 EDETATE SODIUM CHLORPHENESIN METHYLISOTHIAZOLINONE LIMONENE, (+)- CITRUS RETICULATA LEAF OIL CITRONELLA OIL LEMON OIL LIME OIL LAVANDIN OIL MANDARIN OIL APRICOT SEED OIL CORN Exfoliating Acne Treatment Salicylic Acid Salicylic Acid Salicylic Acid WATER ALCOHOL BUTYLENE GLYCOL GLYCOLIC ACID METHYL GLUCETH-10 PPG-5-CETETH-20 ALOE VERA LEAF HYDROGEN PEROXIDE AMINO ACIDS ZINC ASPARTATE ASCORBIC ACID CHITOSAN OLIGOSACCHARIDE RETINOL POLYSORBATE 20 ARNICA MONTANA FLOWER EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP ORANGE LECITHIN, SOYBEAN ALPHA-TOCOPHEROL MAGNESIUM ASCORBYL PHOSPHATE GLYCYRRHIZINATE DIPOTASSIUM AMYLOPECTIN VITIS VINIFERA SEED GREEN TEA LEAF WITCH HAZEL ZINC ACETATE LINOLEIC ACID SODIUM HYDROXIDE PROPYL GALLATE EDETATE DISODIUM EDETATE SODIUM Acne Spot Treatment Sulfur SULFUR SULFUR WATER GLYCOLIC ACID BETASIZOFIRAN DIOCTYL MALEATE CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE POLYOXYL 20 CETOSTEARYL ETHER GLYCERIN OAT ZINC ACETATE ORANGE OIL SALICYLIC ACID LECITHIN, SOYBEAN TOCOPHEROL MAGNESIUM ASCORBYL PHOSPHATE GLYCYRRHIZINATE DIPOTASSIUM VITIS VINIFERA SEED ALLANTOIN SODIUM HYDROXIDE EDETATE DISODIUM DIAZOLIDINYL UREA METHYLPARABEN PROPYLPARABEN Clarifying Mask Sulfur SULFUR SULFUR WATER KAOLIN BENTONITE PROPYLENE GLYCOL GLYCERIN GLYCERYL MONOSTEARATE ZINC OXIDE TALC TITANIUM DIOXIDE CETYL ALCOHOL DIOCTYL MALEATE SALICYLIC ACID TOCOPHEROL MAGNESIUM ASCORBYL PHOSPHATE VITIS VINIFERA SEED GLYCYRRHIZINATE DIPOTASSIUM ALLANTOIN LINALOOL, (+/-)- LAVENDER OIL EDETATE SODIUM METHYLPARABEN BUTYLPARABEN ETHYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN DIAZOLIDINYL UREA METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE CAMPHOR (SYNTHETIC) Skin Perfecting Primer Salicyic Acid SALICYLIC ACID SALICYLIC ACID WATER CYCLOMETHICONE 5 PHENYL TRIMETHICONE DIMETHICONE SILICON DIOXIDE BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL PEG-100 STEARATE GLYCERYL MONOSTEARATE BAMBUSA ARUNDINACEA STEM BORON NITRIDE HYALURONATE SODIUM LENTIL .ALPHA.-GLUCAN OLIGOSACCHARIDE MALTODEXTRIN SACCHARINA LATISSIMA THALLUS PENTYLENE GLYCOL HYDROXYPHENYL PROPAMIDOBENZOIC ACID ALPHA-TOCOPHEROL ACETATE ASCORBIC ACID PROPYL GALLATE ZINC GLUCONATE SODIUM PYRROLIDONE CARBOXYLATE SODIUM LACTATE SORBITOL PROLINE TRIETHOXYCAPRYLYLSILANE POLYETHYLENE GLYCOL 2000 HYDROGENATED CASTOR OIL XANTHAN GUM EDETATE DISODIUM MAGNESIUM ALUMINUM SILICATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE SODIUM HYDROXIDE MICA PHENOXYETHANOL CAPRYLYL GLYCOL CHLORPHENESIN TITANIUM DIOXIDE FERRIC OXIDE RED" ], "openfda": {}, "version": "30942", "dosage_and_administration": [ "Directions Massage a small amount over damped face and neck, rinse with warm water and pat dry.", "Directions Cleanse the skin thoroughly before applying medication, cover the entire affected area with a thin layer one to three times daily, because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician, if bothersome dryness or peeling occurs, reduce application to once a day or every other day", "Directions Cleanse the skin thoroughly before applying medication Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradual increase to two or three times daily if needed or as directed by a physician If bothersome drying or peeling occurs, reduce application to once a day or every other day", "Directions Apply an even layer onto clean skin. Avoid eye area. Leave on for 10 minutes. Remove with damp washcloth and warm water. For best results use at least once a week.", "Directions Apply a thin layer to face under or in place of foundation, if bothersome dryness or peeling occurs, reduce application to every other day." ], "stop_use": [ "Stop use and ask a doctor if, skin rash occurs.", "Stop use and ask a doctor if, skin rash occurs", "Stop use and ask a doctor if, skin rash occurs.", "Stop use and ask a doctor i f skin rash occurs.", "Stop use and ask a doctor if , using other topical acne medications" ], "spl_unclassified_section": [ "SPL Unclassified Murad, Inc. Made in the USA for Murad, Inc. Los Angeles, CA 90245 Murad UK Ltd. 2 Omega Place London N1 9DR, United Kingdom", "SPL Unclassified Murad, Inc. Made in the USA for Murad, Inc. Los Angeles, CA 90245 Murad UK Ltd. 2 Omega Place London N1 9DR, United Kingdom", "SPL Unclassified Murad, Inc. Made in the USA for Murad, Inc. Los Angeles, CA 90245 Murad UK Ltd. 2 Omega Place, London N1 9DR, United Kingdom", "SPL Unclassified Murad, Inc. Made in the USA for Murad, Inc. Los Angeles, CA 90245 Murad UK Ltd. 2 Omega Place, London N1 9DR, United Kingdom" ], "storage_and_handling": [ "Other information •store at room temperature •avoid high temperature •protect from freezing •keep away from flame, fire and heat", "Other information Other information, store at room temperature, avoid high temperatures, protect from freezing, keep away from flame, fire and heat." ], "package_label_principal_display_panel": [ "Package Label Principal Display Panel image of tube image of box", "Package Label Principal Display Panel image of bottle image of box", "Package Label Principal Display Panel image of tube image of box", "Package Label Principal Display Panel image of tube image of box", "Package Label Principal Display Panel image of bottle image of box" ], "indications_and_usage": [ "Use For the management of acne", "Use For the management of acne", "Use For the management of acne", "Use For the management of acne", "Use For the management of acne" ], "set_id": "27d99fa9-d1d2-4e66-a640-0f7e26481909", "id": "99375a1a-9c0e-40de-a6fb-fc76bb50391c", "active_ingredient": [ "Active ingredient Salicylic Acid 1.5%", "Active ingredient Salicylic Acid 1.0%", "Active ingredient Sulfur 3.0%", "Active ingredient Sulfur 4.0%", "Active ingredient Salicylic Acid 0.5%" ] }, { "effective_time": "20151229", "inactive_ingredient": [ "Inactive ingredients aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate." ], "purpose": [ "Purpose Antiemetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately." ], "warnings": [ "Warnings Do not use in children under 12 years of age unless directed by a doctor Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers. When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately." ], "when_using": [ "When using this product may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-645-2158" ], "spl_product_data_elements": [ "Rugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC) Meclizine HCl ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM SULFATE SUCROSE TRICALCIUM PHOSPHATE MECLIZINE HYDROCHLORIDE MECLIZINE Biconvex Uncoated Tablet with Bisect 21G" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "other_safety_information": [ "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Dosage should be taken one hour before travel starts Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Other information Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet store at room temperature" ], "do_not_use": [ "Do not use in children under 12 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses prevents and treats nausea, vomiting or dizziness due to motion sickness" ], "set_id": "280dc4d4-7773-3c13-e054-00144ff8d46c", "id": "280dc4d4-7774-3c13-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each chewable tablet) Meclizine HCl USP 25 mg" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid" ], "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 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 cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use more than directed" ], "spl_product_data_elements": [ "Mucus Relief DM Dextromethorphan HBr and Guiafenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;533" ], "ask_doctor": [ "Ask a doctor before use if you have cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions take with a full glass of water adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. SAFETY SEALED Our Family® Quality Care Since 1904 Mucus Relief DM Guaifenesin 400 mg, Dextromethorphan HBr 20 mg Expectorant Cough Suppressant • Thins and loosens mucus • Controls cough IMMEDIATE-RELEASE 50844 REV0510A53301 DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF13473 Product Packagin Product Packagin" ], "indications_and_usage": [ "Use(s) temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive" ], "set_id": "2955b2f9-e33f-479a-91e6-72c8d1df496d", "id": "4b7d0aa6-f0f2-49df-8bfe-3fa0479b5482", "active_ingredient": [ "Active ingredient(s) Dextromethorphan HBr 20 mg Guaifenesin 400 mg" ] }, { "questions_table": [ "
Amount Per Serving % Daily Value
Calories 10
Sugars 3g
Calcium 800mg 80%
Sodium 10mg (less than 1%)
" ], "effective_time": "20140123", "inactive_ingredient": [ "Inactive ingredients (Ultra) sucrose, calcium carbonate, corn starch, talc, mineral oil, natural and artificial flavors, adipic acid, sodium polyphosphate, red 40 lake, yellow 6 lake, yellow 5 (tartrazine) lake, blue 1 lake", "Inactive ingredients (Assorted Tropical Fruit) calcium stearate, corn starch, FD&C Blue #1, gum acacia, maltodextrin, natural & artificial flavor, sorbitol, sucralose, sucrose, tocopherols" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product (Ultra) • do not take more than 7 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks When using this product (Freshers) • do not take more than 15 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children." ], "when_using": [ "When using this product (Ultra) • do not take more than 7 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks", "When using this product (Freshers) • do not take more than 15 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks" ], "questions": [ "Questions? (Ultra) 1-800-897-7535 weekdays CALCIUM SUPPLEMENT USES: As a daily source of extra calcium. DIRECTIONS: Chew 2 tablets once or twice daily with a meal. Supplement Facts Serving Size: 2 Tablets Servings Per Container: 80 Amount Per Serving % Daily Value Calories 10 Sugars 3g Calcium 800mg 80% Sodium 10mg (less than 1%) Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free PAREVE", "Questions or Comments? (Freshers) 1-800-897-7535 (English/Spanish) weekdays Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free If using this product as a calcium supplement, do not exceed 5 tablets per day without consulting a doctor. TUMS®, FRESHERS® and other marks are trademarks of the GlaxoSmithKline group of companies. PAREVE" ], "spl_product_data_elements": [ "Tums calcium carbonate Tums Ultra calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION SUCROSE STARCH, CORN TALC MINERAL OIL ADIPIC ACID SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 orange, yellow, green TUMS assorted fruit, orange, lemon, lime Tums Freshers calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION CALCIUM STEARATE STARCH, CORN FD&C BLUE NO. 1 ACACIA MALTODEXTRIN SORBITOL SUCRALOSE SUCROSE TOCOPHEROL with blue speckles TUMS cool mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions (Ultra) • chew 2-3 tablets as symptoms occur, or as directed by a doctor", "Directions (Freshers) • take 2-4 tablets as symptoms occur, or as directed by a doctor" ], "spl_unclassified_section": [ "Other information (Ultra) • for calcium and sodium content see Supplement Facts • store below 30 o C (86 o F)", "Other information (Freshers) • each tablet contains: elemental calcium 200 mg • store below 25°C (77°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0543-01 TUMS ® freshers CALCIUM RICH ANTACID cool mint TUMS ® ANTACID/CALCIUM SUPPLEMENT ULTRA STRENGTH 1000 ASSORTED FRUIT NATURALLY & ARTIFICIALLY FLAVORED Special Pack 1-25 ct FRESHERS 1-160 ct ASSORTED FRUIT CHEWABLE TABLETS GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 www.tums.com FIGHT BACK FAST WITH TUMS + Fast Heartburn Relief, Fresh Breath ANYTIME, ANYWHERE. Use as directed. ©2012 GlaxoSmithKline 102322PB Tums Ultra 160 count & Freshers 25 count carton" ], "indications_and_usage": [ "Uses relieves • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms" ], "set_id": "2a1e77a5-f792-4c91-aaba-3671b618a366", "id": "71dddc99-14c6-42da-a44d-9ad1ea5c487b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredient (per tablet) (Ultra) Calcium carbonate USP 1,000 mg", "Active ingredient (per tablet) (Freshers) Calcium carbonate USP 500 mg" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate)." ], "purpose": [ "Purpose Anti-itch" ], "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 in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding 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 avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator" ], "questions": [ "Questions? Call 1-866-923-4914" ], "spl_product_data_elements": [ "meijer Hydrocortisone Hydrocortisone Hydrocortisone Hydrocortisone aloe vera whole cetostearyl alcohol sodium lauryl sulfate sodium cetostearyl sulfate chamomile flower oil citric acid monohydrate corn oil glycerin glyceryl monostearate isopropyl palmitate maltodextrin methylparaben mineral oil paraffin petrolatum propylene glycol propylparaben water stearyl alcohol Vitamin A palmitate cholecalciferol .alpha.-tocopherol acetate" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544" ], "stop_use": [ "Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs" ], "storage_and_handling": [ "Other information To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube Store between 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 g Tube Carton meijer ™ Intensive Healing Formula † Hydrocortisone Cream 1% Antipruritic (Anti-Itch) † Enriched with Vitamins A, D, & E NET WT 1 oz (30 g) PRINCIPAL DISPLAY PANEL - 30 g Tube Carton" ], "indications_and_usage": [ "Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor" ], "set_id": "2a451dcd-2f10-4ac5-b7c6-5f742ec7a421", "id": "adcef4da-6521-4766-9f8e-a7161526504d", "active_ingredient": [ "Active Ingredient Hydrocortisone 1%" ] }, { "effective_time": "20130109", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information" ], "indications_and_usage": [ "Uses for the temporary relief of: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, and hay fever or other upper respiratory allergies" ], "set_id": "2a9d2ec5-3b62-49a6-9a8f-e2aa9359bdba", "id": "8cefa83b-202c-41d0-9965-ed615ffce5eb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL POVIDONES STARCH, CORN PROPYLENE GLYCOL STEARIC ACID TALC TITANIUM DIOXIDE AAA;1119" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton NDC 57344-119-05 RESTORE u † COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL ® SINUS CONGESTION & PAIN - SEVERE See New Warnings Information & Directions DAYTIME NON-DROWSY Severe Sinus For Adults CONGESTION & PAIN Pain Reliever, Nasal Decongestant, Expectorant Sinus Headache – Acetaminophen Nasal Congestion/Sinus Pressure – Phenylephrine HCl Clears Mucus, Chest Congestion – Guaifenesin 24 CAPLETS PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20111014", "inactive_ingredient": [ "Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid, titanium dioxide* * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding , ask a health professional before use." ], "questions": [ "Questions or comments? 1-800-356-0783" ], "spl_product_data_elements": [ "Rapid Comfort Non Aspirin Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES MALTODEXTRIN POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID white ROUND FR;2" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding , ask a health professional before use." ], "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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor" ], "package_label_principal_display_panel": [ "145R LSS Non-Aspirin 325 mg Label Rapid Comfort™ Non-Aspirin Acetaminophen 325 mg Easy to Swallow Film-Coated Tablets Pull to Open Compare Active ingredients to: Tylenol® Registered Trademark of McNeil Consumer 100 Tablets (50 x 2s) Tamper Evident Unit Dose Packets 145R LSS Non-Aspirin 325 mg Label" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain common cold toothache menstrual cramps For the reduction of fever." ], "set_id": "2ab9c6ff-3d09-4168-b669-f393b6ce50c7", "id": "a82be2c1-4eec-4966-aa6e-68a9e4f87144", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 325 mg" ] }, { "effective_time": "20121228", "inactive_ingredient": [ "Inactive ingredients carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide *contains one or more of these ingredients" ], "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." ], "warnings": [ "Warnings" ], "questions": [ "Questions or comments? Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST" ], "spl_product_data_elements": [ "Senna S docusate sodium and sennosides SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CARNAUBA WAX CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED WATER SILICON DIOXIDE SODIUM BENZOATE STEARIC ACID TALC TITANIUM DIOXIDE TCL081;SS1;S35" ], "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" ], "other_safety_information": [ "Other Information each tablet contains: sodium 6 mg/tablet LOW SODIUM each tablet contains: Calcium 20 mg/tablet store at 15 o - 30 o C (59 o -86 o F) in well closed containers do not use if imprinted safety seal under cap is broken or missing **This product is not manufactured or distributed by Purdue products L.P., owner of the registered trademark Senokot-S®" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age or older 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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "do_not_use": [ "Do not use 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": [ "Principal Display Panel Compare to the active ingredients in Senokot- S® ** SENNA-S Laxative/ Stool softener Standardized senna concentrate 8.6 mg and Docusate Sodium 50 mg Natural vegetable laxative ingredient plus stool softener DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: American Sales Company 4201 Walden avenue, Lancaster, NY 14086 www.care1.com", "Product Label Senna-S Laxative/stool softener CareOne" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours" ], "set_id": "2cc65650-e643-40f8-a080-fbe62bac379c", "id": "82d1df85-ade7-407d-ba00-077b1efd3924", "active_ingredient": [ "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
age starting dosage maximum dosage
adults and children 12 years of age or older 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
" ] }, { "effective_time": "20151105", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Dimethicone Paraffin Microcrystalline Wax Fragrance (Parfum) Silica Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Dimethicone Crosspolymer Hydrated silica Maltodextrin Gelatin crosspolymer Hydrolyzed Corn Starch Cellulose Gum BHT" ], "purpose": [ "Purpose anti-perspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Clinical Protection Motion Sense Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 DIMETHICONE MICROCRYSTALLINE WAX SILICON DIOXIDE HYDRATED SILICA MALTODEXTRIN STARCH, CORN GELATIN CARBOXYMETHYLCELLULOSE SODIUM BUTYLATED HYDROXYTOLUENE PARAFFIN" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions ▪ apply to underarms only ▪ before bed, apply two clicks of product to each underarm" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "1.7 oz PDP DegreeClinProtectClassicRomance1pt7PDPrev4", "1.7 oz carton DegreeClinProtectClassicRomance1pt7cartonrev4" ], "indications_and_usage": [ "Uses ▪ reduces underarm wetness ▪ extra effective" ], "set_id": "2fa6ff30-8a1f-4b38-9795-99ca4ea5c95b", "id": "fac83990-931b-43e7-b749-078d26481768", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (20%)" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Stearyl Alcohol C12-15 Alkyl Benzoate PPG-14 Butyl Ether Hydrogenated Castor Oil Fragrance (Parfum) Dimethicone Polyethylene Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Helianthus Annuus (Sunflower) Seed Oil Maltodextrin Hydrated Silica Hydrolyzed Corn Starch Gelatin Crosspolymer BHT Silica Cellulose Gum" ], "purpose": [ "Purpose anti-perspirant" ], "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" ], "questions": [ "Questions? Call toll-free 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree Motion Sense Linen Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE STEARYL ALCOHOL HYDROGENATED CASTOR OIL PPG-14 BUTYL ETHER BUTYLATED HYDROXYTOLUENE DIMETHICONE SUNFLOWER OIL MALTODEXTRIN HYDRATED SILICA SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP Degree Motion Sense Linen Dry", "DFW 48 hour label DFW 48 hour label" ], "indications_and_usage": [ "Uses · reduces underarm wetness" ], "set_id": "2fd8c569-a352-4652-ba9e-c1d040fd96ee", "id": "712711b6-7968-49fc-a9e9-29aab2552544", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (18.2%)" ] }, { "effective_time": "20120109", "inactive_ingredient": [ "Inactive ingredients Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "questions": [ "Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "spl_product_data_elements": [ "GUAIFENESIN AND DEXTROMETHORPHAN BHR GUAIFENESIN AND DEXTROMETHORPHAN BHR GUAIFENESIN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE WHITE Capsule shape C;26" ], "ask_doctor": [ "Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)" ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant Dextromethorphan HBr 15 mg............................... Antitussive Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive and provide relief from dry, non-productive coughs. Warnings Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. Directions Do not exceed 6 doses in 24 hours. Take with a full glass of water. Adults and children 12 years of age and over: 1 tablet, every4 hours Children 6 years to under 12 years: 1/2 tablet, every 4 hours Children under 6 years of age: ask a doctor Other information store between 150°- 30°C (59°- 86°F) do not use if carton is opened Inactive ingredients Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, povidone Questions or Comments? Call 1-866-383-9908 Manufactured by: Cispharma Inc 1212 Cranbury S River Road Cranbury, NJ 08512" ], "stop_use": [ "Stop use and ask a doctor if Cough lasts more than 7 days, comes back, or occurs with fever rash or persistent headache. These could be signs of a serious illness." ], "package_label_principal_display_panel": [ "Expectorant NDC number 52204-126-99 Antitussive GUAIFENESIN AND DEXTROMETHORPHAN BHR, 400 mg / 15mg" ], "set_id": "30d4a02c-eb2b-4140-975c-edb608f05059", "id": "30d4a02c-eb2b-4140-975c-edb608f05059", "active_ingredient": [ "Active ingredient (in each tablet) Purpose Guaifenesin USP 400 mg..................................... Expectorant Dextromethorphan HBr 15 mg............................... Antitussive" ] }, { "effective_time": "20140520", "inactive_ingredient": [ "Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - nasal and sinus congestion - cough due to minor throat and bronchial irritation - runny nose - sneezing - itchy, watery eyes due to hay fever - itchy nose and throat - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "spl_product_data_elements": [ "TopCare Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Acesulfame Aspartame Citric acid monohydrate Maltodextrin Sodium Citrate Sucrose Natural Honey and Lemon Flavor Natural Honey and Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor. - if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "31108eec-b555-4dd3-afe3-4073cb1be075", "id": "9d086914-86f6-45f3-8bfa-4bdb00fdc3bf", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg ........................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg...................................Nasal decongestant." ] }, { "effective_time": "20091023", "inactive_ingredient": [ "Inactive Ingredients Fractionated coconut oil, Hypromellose, Maltodextrin, Microcrystalline cellulose, Polydextrose, Sodium starch glycolate, Stearic acid, Talc, Titanium dioxide." ], "purpose": [ "Uses for the temporary relief of minor aches and pain associated with: Tension Headaches Sinus Headaches Stress Headaches Chronic Headaches Menstrual Headaches" ], "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 Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include hives, asthma (wheezing), facial swelling, shock, rash, skin reddening, and blisters. Alcohol warning : If you consume 3 or more alcoholic drinks everyday, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding." ], "questions": [ "Questions or comments: 1 877 - 466 - 0294. Distributed by Migralex Inc. Larchmont, New York 10538 Made in Canada U.S. Patent #5538959, 5914129 TAMPER EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS BROKEN OR MISSING" ], "spl_product_data_elements": [ "Migralex Dr. Mauskop Aspirin buffered with magnesium oxide aspirin aspirin magnesium oxide magnesium oxide M" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease asthma a magnesium-restricted diet bleeding problems stomach problems that last or come back (such as heartburn, upset stomach or stomach pain), or if you have ulcers." ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if allergic reaction occurs. Seek medical help right away. pain gets worse or lasts for more than 10 days new symptoms occur fever gets worse or lasts for more than 3 days ringing in the ears or a loss of hearing occurs redness or swelling is present" ], "storage_and_handling": [ "Directions Drink a full glass of water with each dose Adults and children 12 years and over: take 2 tablets every 6 hours while symptoms persist, but not more than 8 tablets in 24 hours, or as directed by a doctor Children under 12 years: ask a doctor Other Information store at room temperature read all product information before using save carton for full directions and warnings" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "image of carton label image of bottle label" ], "set_id": "31962eb9-690c-4727-852d-d6dfbf842c2a", "id": "0be179e8-6b58-424d-8af2-be237a80bc84", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active Ingredients (in each tablet) Aspirin 500 mg (Purpose: Pain Reliever) Buffered with Magnesium Oxide 75 mg" ] }, { "effective_time": "20131006", "inactive_ingredient": [ "Inactive Ingredients dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid" ], "purpose": [ "Purpose Antiflatulent" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc." ], "spl_product_data_elements": [ "MYTAB For GAS Simethicone DIMETHICONE DIMETHICONE DEXTROSE SUCROSE MALTODEXTRIN PEPPERMINT SORBITOL STEARIC ACID AP;019" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician" ], "spl_unclassified_section": [ "Drug Facts .", "Other Information store at room temperature 15-30 °C (59-86 °F) protect from moisture" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-2163-3 Packaged by: A-S Medication Solutions Libertyville, IL 60048 2163-3.jpg" ], "indications_and_usage": [ "Uses relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing" ], "set_id": "322ffda3-0044-4836-9208-a8aa19746960", "id": "2893572a-b7fd-449f-9a73-d5caa5e1cb47", "active_ingredient": [ "Active Ingredient (in each chewable tablet) Simethicone 80 mg" ] }, { "effective_time": "20130426", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, corn starch, dextrose excipient, FD&C blue #1, FD&C red # 3, flavor, magnesium stearate, maltitol, maltodextrin, pregelatinized starch, silicon dioxide, sucrose" ], "purpose": [ "Active ingredients (in each tablet) Purpose Calcium carbonate 675 mg Antacid Magnesium hydroxide 135 mg Antacid Simethicone 60 mg Antigas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 8 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Keep out of reach of children" ], "questions": [ "Questions or comments? call 1-800-223-0182" ], "spl_product_data_elements": [ "Rolaids Multi-Symptom Calcium Carbonate, magnesium hydroxide, and dimethicone Calcium Carbonate Carbonate Ion Magnesium Hydroxide Hydroxide Ion Dimethicone dimethicone ACESULFAME POTASSIUM STARCH, CORN FD&C BLUE NO. 1 FD&C RED NO. 3 MAGNESIUM STEARATE MALTITOL MALTODEXTRIN SILICON DIOXIDE SUCROSE White with purple specks R" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions chew 2 to 4 tablets, hourly if needed" ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other information each tablet contains: calcium 270 mg, magnesium 55 mg store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton is open or roll wrap is open or torn see side panel for lot number and expiration date" ], "do_not_use": [ "Do not take more than 8 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician." ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Calcium carbonate 675 mg Antacid
Magnesium hydroxide 135 mg Antacid
Simethicone 60 mg Antigas
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NEW LOOK! Same Trusted Relief MULTI-SYMPTOM NDC 50580-748-30 Rolaids ® Antacid PLUS Anti-Gas FAST ACTING Relieves ▶ Heartburn ▶ Acid Indigestion ▶ Bloating & Pressure from Gas 3 Rolls 30 Total Tablets Berry Principal Display Panel" ], "indications_and_usage": [ "Uses relieves: heartburn acid indigestion pressure, bloating and discomfort commonly referred to as gas" ], "set_id": "3279b04c-2ef1-43f8-b3a8-10383c2afa6d", "id": "c52c4b6c-b8db-47e6-ad8e-15c200cb7a68", "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Calcium carbonate 675 mg Antacid
Magnesium hydroxide 135 mg Antacid
Simethicone 60 mg Antigas
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each tablet) Purpose Calcium carbonate 675 mg Antacid Magnesium hydroxide 135 mg Antacid Simethicone 60 mg Antigas" ] }, { "effective_time": "20101004", "inactive_ingredient": [ "Inactive ingredients aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin" ], "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 Center right away (1-800-222-1222)." ], "warnings": [ "Warnings Do not use with any other product containing Diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to an enlargement of prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product Avoid alcoholic beverages Marked drowsiness may occur Alcohol, sedatives and tranquilizers may increase the drowsiness effect Excitability may occur, especially in children Be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center right away (1-800-222-1222)." ], "when_using": [ "When using this product Avoid alcoholic beverages Marked drowsiness may occur Alcohol, sedatives and tranquilizers may increase the drowsiness effect Excitability may occur, especially in children Be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ETHYLCELLULOSE ANHYDROUS CITRIC ACID CROSPOVIDONE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MALTODEXTRIN MANNITOL METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO SUCRALOSE TALC TRIACETIN AMMONIA CAPRYLIC/CAPRIC MONO/DIGLYCERIDES OLEIC ACID None" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to an enlargement of prostate gland", "Ask a doctor before use if you are taking sedatives or tranquilizers" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Take every 4 to 6 hours Do not take more than 6 times in 24 hours Adults and Children 12 years of age and over 2 to 4 tablets Children 6 to under 12 years of age 1 to 2 tablets Children under 6 years of age Consult a doctor Children under 4 years of age Do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Other Information Do not use if carton is opened or blister unit is broken Store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. See end panel for lot number and expiration date." ], "do_not_use": [ "Do not use with any other product containing Diphenhydramine, even one used on skin to make a child sleepy" ], "package_label_principal_display_panel": [ "Principal Display Panel Capricorn Pharma ORIGINAL DEVELOPERS AND MANUFACTURERS NDC 66007-212-02 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT Children's Allergy Diphenhydramine HCl 12.5mg ANTIHISTAMINE Temporarily Relieves: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat Cherry Flavor RAPIDMELT 18 Fast Dissolving Tablets Diphenhydramine HCl Antihistamine carton" ], "indications_and_usage": [ "Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis." ], "set_id": "327ccd2d-dcc6-4919-83d7-51d8920b7b01", "id": "557a995c-3fe4-411c-94ef-f6d4f1bd0a55", "active_ingredient": [ "Active ingredient (in each tablet) Diphenhydramine HCl 12.5mg" ], "dosage_and_administration_table": [ "
Adults and Children 12 years of age and over 2 to 4 tablets
Children 6 to under 12 years of age 1 to 2 tablets
Children under 6 years of age Consult a doctor
Children under 4 years of age Do not use
" ] }, { "effective_time": "20140630", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, pregelatinized starch" ], "purpose": [ "Purpose Alertness aid" ], "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 For occasional use only Do not use • in children under 12 years of age • as a substitute for sleep When using this product limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as two cups of coffee. Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as two cups of coffee." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "Smart Sense Stay Awake Caffeine CAFFEINE CAFFEINE DEXTROSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MALTODEXTRIN L409" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur" ], "storage_and_handling": [ "Other information • store at 20-25°C (68-77°F)" ], "do_not_use": [ "Do not use • in children under 12 years of age • as a substitute for sleep" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredient of Vivarin® Tablets ALERTNESS AID Stay Awake Contains 200 mg Caffeine ACTUAL SIZE 40 TABLETS 200 mg Each Smart Sense Stay Awake Image 1 Smart Sense Stay Awake Image 2" ], "indications_and_usage": [ "Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness" ], "set_id": "32dc5dc7-29c5-46c6-a7fe-1866e250f42a", "id": "5a86338c-04ed-4c09-9df1-55b8159caa11", "active_ingredient": [ "Active ingredient (in each tablet) Caffeine 200 mg" ] }, { "effective_time": "20120910", "inactive_ingredient": [ "Inactive ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid." ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)" ], "spl_product_data_elements": [ "The Medicine Shoppe Chest Congestion Relief Guaifenesin Guaifenesin Guaifenesin MALTODEXTRIN STEARIC ACID SILICON DIOXIDE COPOVIDONE MAGNESIUM STEARATE PH063" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , 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." ], "storage_and_handling": [ "Other Information store at 15°-30°C (59°-86°F)" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive" ], "set_id": "3316b6a5-c0d6-4dd3-9e93-a29d35fc5251", "id": "882bb8d4-69fc-4ce8-97d4-e062d6b8ad52", "active_ingredient": [ "Active ingredient (per tablet) Guaifenesin 400mg" ] }, { "effective_time": "20121115", "inactive_ingredient": [ "Inactive ingredients acrylates copolymer, ammonium lauryl sulfate, citrus aurantium bergamia (bergamot) fruit oil, cocamidopropyl betaine, disodium cocoyl glutamate, disodium EDTA, DMDM hydantoin, fragrance, glycerin, honey, lauryl glucoside, malpighia glaba (acerola) fruit extract, maltodextrin, menthol, mica, polyethylene, purified water, sodium cocoyl glutamate, sodium hydroxide, sodium laureth sulfate, sodium lauroyl sarcosinate, titanium dioxide, tocopheryl acetate." ], "purpose": [ "Purpose Acne treatment" ], "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 Allergy alert do not use this product if you have a known allergy to salicylic acid When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. 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 skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time." ], "spl_product_data_elements": [ "Stridex Conditioning Acne Scrub Salicylic Acid Salicylic Acid Salicylic Acid ammonium lauryl sulfate bergamot oil cocamidopropyl betaine disodium cocoyl glutamate Edetate Disodium DMDM hydantoin glycerin honey lauryl glucoside malpighia glabra fruit maltodextrin menthol mica high density polyethylene water sodium cocoyl glutamate sodium hydroxide sodium laureth-3 sulfate sodium lauroyl sarcosinate titanium dioxide .alpha.-tocopherol acetate" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions wet face cover the entire affected area with a thin layer, massaging gently, and rinse thoroughly, use one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day" ], "spl_unclassified_section": [ "Drug Facts" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 177mL Tube Label NDC 10157-1042-1 SINGLE-STEP ACNE CONTROL ® New! STRIDEX® SALICYLIC ACID 2.0% W/W ACNE MEDICATION CONDITIONING ACNE SCRUB WITH SUPER-FINE EXFOLIATING SPHERES SCRUBS PORES WITHOUT SCRATCHING SMOOTHES SKIN TREATS & PREVENTS ACNE SOOTHES & COOLS PLUS VITAMINS & BOTANICALS Acerola, Bergamot & Honey Extract 6 fl oz (177ml) Principal Display Panel - 177mL Tube Label" ], "indications_and_usage": [ "Uses for the treatment of acne reduces the number of acne pimples and blackheads and allows skin to heal helps prevent new acne pimples from forming" ], "set_id": "3316e7be-38c4-408d-8e8c-1035d9d7cee8", "id": "d0953407-9274-4f98-af74-c1704a425a7b", "active_ingredient": [ "Active ingredient Salicylic acid 2.0% (w/w)" ] }, { "effective_time": "20151209", "inactive_ingredient": [ "Acesulfame K, aspartame, caramel color, citric acid, D and C Yellow 10, maltodextrin, natural flavors, sodium citrate, starch and sugar." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose and throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "spl_product_data_elements": [ "Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. ACESULFAME ASPARTAME CITRIC ACID MONOHYDRATE MALTODEXTRIN SODIUM CITRATE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey & Lemon Flavor Natural Honey & Lemon Flavor Caramel Color D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor - If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin -If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 7 mg, sodium 46 mg - phenylketonurics: contains phenylalanine 13 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "331f14b8-55fb-4ad8-83a8-95a7ed740c82", "id": "267ca7df-1a15-6d1b-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg .......................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg .................................Nasal decongestant." ] }, { "effective_time": "20150416", "inactive_ingredient": [ "Inactive Ingredients Blue #1, dextrose, flavors, magnesium stearate, maltodextrin, red #40, yellow #6, yellow #10 Manufactured by: A&Z Pharmaceutical, Inc. Happauge, NY 11788" ], "purpose": [ "Purpose Acid Indigestion, Heartburn, Sour & Upset Stomach" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children" ], "warnings": [ "Warnings" ], "when_using": [ "When Using do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks." ], "spl_product_data_elements": [ "Calcium Antacid Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION FD&C BLUE NO. 1 DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 FD&C YELLOW NO. 6 D&C YELLOW NO. 10 AZ;024" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • chew 2-4 tablets as symptoms occur, repeat hourly if needed Other Information • store at 59°-86°F • do not use if imprinted safety seal under cap is broken or missing • Calcium content per tablet: 200mg Supplement Facts • Serving size 2 tablets • Servings per Container: 25 • Amount Per Serving Calories: 5 Calcium: 400mg(40%DV)" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Sodium Free CALCIUM ANTACID Regular Strength 500 mg Calcium Supplement Fast Relief of Acid Indigestion, Heartburn, Sour & Upset Stomach 50 Tablets Assorted Fruit Chewable Tablets Compare to Tums ® Active Ingredient * W:\\Share\\Bashir\\Labeling\\A2Z Artwork & proofs\\Antacid Asst 500 mg 50s\\antacid asst 500mg 50s front.jpg" ], "indications_and_usage": [ "Uses relieves • heartburn • acid • indigestion • sour stomach • upset stomach due to these symptoms" ], "set_id": "33376895-edf5-4dde-8614-b9798e97b9ed", "id": "61bac10c-afa8-44e6-8831-12960c487e91", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are When Using do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks." ], "active_ingredient": [ "Active ingredient Calcium Carbonate 500 mg" ] }, { "effective_time": "20150120", "inactive_ingredient": [ "Inactive ingredients corn starch, hypromellose, maltodextrin, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide* * May contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve pain or fever persists or gets worse new symptoms occur redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or comments? 1-800-240-6373" ], "spl_product_data_elements": [ "Lab Safety Supply - Rapid Comfort Extra Strength Non-Aspirin Acetaminophen HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN white ROUND AZ;235" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop using and ask a doctor if symptoms do not improve pain or fever persists or gets worse new symptoms occur redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel 175R LSS XS Non Aspirin 500 mg Label Rapid Comfort® Extra Strength Non-Aspirin Acetaminophen 500 mg Easy to Swallow Film-Coated Tablets Pull to Open Compare active ingredient to: Extra Strength Tylenol® Registered Trademark of McNeil Consumer Products See new warnings information 100 Tablets (50 x 2s) Tamper-Evident Unit Dose Packets 175R LSS XS Non Aspirin 500 mg Label" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains associated with headache toothache minor arthritis pain muscular aches common cold menstrual cramps For the reduction of fever." ], "set_id": "33cc7a38-f33c-42dd-bb85-ce389fdbf5ad", "id": "0d1b5959-de3b-3e98-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 500 mg" ] }, { "effective_time": "20130702", "inactive_ingredient": [ "Inactive ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid." ], "purpose": [ "Purpose Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough is accompanied by excessive phlegm (mucus)" ], "spl_product_data_elements": [ "Shopko Chest Congestion Relief Guaifenesin Guaifenesin Guaifenesin MALTODEXTRIN STEARIC ACID SILICON DIOXIDE COPOVIDONE MAGNESIUM STEARATE PH063" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , 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." ], "storage_and_handling": [ "Other Information store at 15°-30°C (59°-86°F)" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive" ], "set_id": "33ea8e0c-0221-42b1-9a74-3ba5e6c2db79", "id": "16730c70-ef40-49bb-b5ac-86fb703bbe65", "active_ingredient": [ "Active ingredient (per tablet) Guaifenesin 400mg" ] }, { "effective_time": "20120806", "inactive_ingredient": [ "INGREDIENTS WATER • BUTYLENE GLYCOL • ISONONYL ISONONANDATE • BUTYLOCTYL SALICYLATE • TRIACONTANYL PVP • POLYESTER-8 • SILICA • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • STEARYL DIMETHICONE • CAFFEINE • PLANKTON EXTRACT • SUCROSE • HYDROGENATED LECITHIN • POTASSIUM CETYL PHOSPHATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • PEG-100 STEARATE • CETYL ALCOHOL • POLYETHYLENE • ACRYLIC ACID/VP CROSSPOLYMER • VP/EICOSENE COPOLYMER • TOCOPHERYL ACETATE • TROMETHAMINE • SODIUM RNA • ALOE BARBADENSIS POWDER • PHOSPHOLIPIDS • LECITHIN • MAGNESIUM ASCORBYL PHOSPHATE • SODIUM HYALURONATE • HYDROXYPROPYL METHYLCELLULOSE • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • ASCORBYL TOCOPHERYL MALEATE • MALTODEXTRIN • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • FERULIC ACID • DISODIUM EDTA • PHENOXYETHANOL • CHLORPHENESIN • MICA [ILN34995]" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help right away." ], "warnings": [ "WARNING For external use only. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help right away." ], "spl_product_data_elements": [ "CLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION homosalate, octisalate, avobenzone, and octocrylene homosalate homosalate octisalate octisalate avobenzone avobenzone octocrylene octocrylene water butylene glycol isononyl isononanoate butyloctyl salicylate triacontanyl pvp (wp-660) silicon dioxide rosemary perilla frutescens leaf caffeine sucrose potassium cetyl phosphate peg-100 stearate cetyl alcohol high density polyethylene .alpha.-tocopherol acetate tromethamine magnesium ascorbyl phosphate hyaluronate sodium maltodextrin caprylyl glycol hexylene glycol masoprocol ferulic acid edetate disodium phenoxyethanol chlorphenesin mica" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "spl_unclassified_section": [ "CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 150 ml Carton CLINIQUE SPF 15 with SolarSmart UVA UVB advanced protection face/body cream 5 FL. OZ. 150 ml e Principal Display Panel - 150 ml Carton" ], "indications_and_usage": [ "TO USE Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring." ], "set_id": "340c82a5-bbf5-4528-bb25-51aa267f3b8a", "id": "ccaf35c2-e800-4f09-9881-55decb422123", "active_ingredient": [ "ACTIVE INGREDIENTS HOMOSALATE 10.0% • OCTISALATE 5.0% • AVOBENZONE 3.0% • OCTOCRYLENE 2.7%" ] }, { "effective_time": "20120809", "inactive_ingredient": [ "Inactive ingredients aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide. DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING" ], "purpose": [ "Purpose Bulk-forming laxative" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Warnings Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed the maximum recommended daily dosage in a 24-hour period you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake" ], "spl_product_data_elements": [ "Health Mart fiber psyllium husk PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain, nausea or vomiting a sudden change in bowel habits persisting for 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take at the first sign of irregularity up to 3 times a day put one dose into an empty glass fill glass with 8oz of water or favorite beverage stir briskly and drink promptly if mixture thickens add more water and stir take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary adults and children 12 years and over 1 rounded teaspoon 6 to under 12 years 1/2 teaspoon under 6 years ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if constipation lasts more than 7 days rectal bleeding occurs These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Fiber Supplement Information Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program. Warnings Read entire label, including warnings in Drug Facts Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) in 8 oz of liquid 3 times daily. Children under 12 years : Consult a doctor. NOTICE : Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you havbe difficulty swallowing. See choking warning." ], "storage_and_handling": [ "Other information each teaspoon contains: potassium 30 mg and sodium 5 mg Phenylketonurics: contains phenylalanine 25 mg per teaspoon store at (20 o -25 o C) 68 o -77 o F" ], "package_label_principal_display_panel": [ "PDP Health Mart Pharmacy Compare to Metamucil ® active ingredient fiber powder psyllium husk 3.4 g bulk-forming laxative dietary fiber supplement helps maintain and restore regularity sugar free smooth texture orange flavor net wt 10 oz (283 g) 48 teaspoon doses sugar free smooth texture" ], "indications_and_usage": [ "Uses effective in treating occasional constipation and restoring regularity" ], "set_id": "352b19c5-12d2-45c5-b161-0d9fdc0cdc57", "id": "4a145697-965e-4a46-81cc-b99535f3c132", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (per each rounded teaspoon=5.8 g) psyllium husk 3.4 g" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 1 rounded teaspoon
6 to under 12 years 1/2 teaspoon
under 6 years ask a doctor
" ] }, { "effective_time": "20150716", "inactive_ingredient": [ "Inactive ingredients Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid." ], "purpose": [ "Purpose Anti-Gas" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children." ], "warnings": [ "Warnings If pregnant or breast-feeding , ask a health professional before use. Keep this and all drugs out of the reach of children." ], "questions": [ "Questions? If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817." ], "spl_product_data_elements": [ "Blonil Simethicone DIMETHICONE DIMETHICONE FRUCTOSE MALTODEXTRIN SILICON DIOXIDE SORBITOL STARCH, CORN STEARIC ACID Natural and Artificial Round Flat Faced Beveled Edge GPI;LB" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults: Chew 1 or 2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets per day except under the advice and supervision of a physician." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Other Information Store at room temperature. Avoid high humidity. Do not use if imprinted safety seal under cap is broken or missing." ], "package_label_principal_display_panel": [ "Principal Display Panel BLONIL Simethicone 80 mg Anti Gas Relieves Gas Fast Pressure Bloating Discomfort 100 CHEWABLE TABLETS 80mg Each untitled.jpg" ], "indications_and_usage": [ "Uses Relieves bloating and pressure commonly referred to as gas." ], "set_id": "352c3aa1-0935-4fc7-b154-4ee1107c7357", "id": "998ce6dd-0c91-407a-8d3d-992f3f688165", "active_ingredient": [ "Active ingredient (in each tablet) Simethicone 80 mg, USP" ] }, { "effective_time": "20151208", "inactive_ingredient": [ "Acesulfame K, aspartame, calcium phosphate dibasic, citric acid, D and C Yellow 10, maltodextrin, natural flavor, silicon dioxide, sodium citrate dihydrate." ], "purpose": [ "Uses - temporarily relieves: - minor aches and pains - minor sore throat pain - headache - nasal and sinus congestion - runny nose - sneezing - itchy nose and throat - itchy, watery eyes due to hay fever - cough due to minor throat and bronchial irritation - temporarily reduces fever." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "spl_product_data_elements": [ "Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough Natural honey lemon flavor Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. ACESULFAME ASPARTAME CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CITRIC ACID MONOHYDRATE MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Natural Honey & Lemon Flavor Natural Honey & Lemon Flavor D & C Yellow 10" ], "ask_doctor": [ "Ask a doctor before use if you have - liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - do not use more than directed - take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor. - adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. - children under 12 years of age: consult a doctor - If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if - nervousness, dizziness, or sleeplessness occurs - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - symptoms do not get better or worsen - pain, cough or nasal congestion gets worse or lasts more than 7 days - cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use - In a child under 4 years of age. - With any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - with any other product containing diphenhydramine, even one used on the skin -If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product." ], "information_for_patients": [ "Other information - each packet contains: potassium 10 mg, sodium 19 mg - phenylketonurics: contains phenylalanine 11 mg per packet - store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture." ], "package_label_principal_display_panel": [ "MM1.jpg" ], "indications_and_usage": [ "When using this product - do not exceed recommended dosage - avoid alcoholic drinks - marked drowsiness may occur - alcohol, sedatives and tranquilizers may increase drowsiness - be careful when driving a motor vehicle or operating machinery - excitability may occur, especially in children." ], "set_id": "3568f379-3743-4a83-b7b1-887c19d24020", "id": "2665a8b7-5f72-401c-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are - taking sedatives or tranquilizers - taking the blood thinning drug warfarin." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredients (in each packet) Purpose Acetaminophen 650 mg .......................................Pain reliever/Fever reducer Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant Phenylephrine hydrochloride 10 mg .................................Nasal decongestant." ] }, { "effective_time": "20110915", "inactive_ingredient": [ "Inactive Ingredients : Mica , Boron Nitride , Caprylic/Capric Triglyceride , Bismuth Oxychloride , Zinc Stearate , Magnesium Silicate , Magnesium Carbonate ,Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate , Citric Acid, Sodium Citrate , Walthena Indica Leaf Extract , Dextrin , Ferulic Acid, L-Lactic Acid, Butyrospermum Parkii (Shea Butter) , Silica, Thioctic Acid,Sodium Hyarluronate, Retinol, L-Ascorbic Acid, Ceramide 6 II , Magnolia Officinalis Bark Extract, Vitis Vinifera (Grape) Seed Extract , Tocopherol , Lecithin , Maltodextrin , Vitis Vinifera (Grape) Fruit Skin, Glycerin, Palmitoyl Tripeptide-5, L-Glucothione, Aloe Barbadensis Leaf Extract, Hydrated Silica , Tocopheryl Acetate , Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambus Vulgaris Leaf/Stem Extract, Magnesium Carbonate , Iron oxide , May contain : Titanium Dioxide, Ultramarines." ], "purpose": [ "Purpose : Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children ." ], "warnings": [ "For external use only. Please avoid contact inside eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "4 in 1 Pressed Mineral SPF 15 Medium Dark Titanium Dioxide Mica Titanium Dioxide Titanium Dioxide Boron Nitride MEDIUM-CHAIN TRIGLYCERIDES Bismuth Oxychloride Zinc Stearate Magnesium Silicate MAGNESIUM CARBONATE SILICON DIOXIDE Shea Butter Acetate Ion Iron" ], "openfda": {}, "version": "1", "stop_use": [ "Discontinue use If rash or irritation develops and increases. If irritation persists, consult a health care practitioner or Contact a Poison Control Center right away." ], "package_label_principal_display_panel": [ "" ], "set_id": "370084dd-835b-4839-9fa8-45055a454369", "id": "768678a7-0132-4308-9a6d-545ff982c3c3", "active_ingredient": [ "Active Ingredient : Titanium Dioxide 9 % Image of Label" ] }, { "effective_time": "20120906", "inactive_ingredient": [ "Inactive ingredients beet juice extract, carrageenan, glycerin, gum arabic, maltodextrin, natural flavor, oat fiber, pectin, polysorbate 80, stevia, vanillin, xylitol" ], "purpose": [ "Purpose Chamomilla (chamomile) 3X HPUS....................pain & irritability reliever Coffea cruda (coffee seed) 3X HPUS..................calming aid Calcarea phosphorica (calcium phosphate) 12X....supports dentition" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Warnings: Do not use if packet seal is torn or broken." ], "questions": [ "Questions or Comments? 1-866-267-8710 or www.humphreysbaby.com Distributed by: Humphreys Pharmacal, Inc. East Hampton, CT 06424 Made in USA" ], "spl_product_data_elements": [ "Humphreys Baby Teething Relief Cherry Swift Strips matricaria recutita, arabica coffee bean, tribasic calcium phosphate matricaria recutita matricaria recutita arabica coffee bean arabica coffee bean tribasic calcium phosphate calcium cation beet juice carrageenan glycerin acacia maltodextrin oat bran pectin polysorbate 80 stevia rebaudiuna leaf vanillin xylitol natural flavor translucent pink rectangle" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Open packet, tear in half along perforation. Peel from corner to expose strip. Place 1 strip on tongue and allow to dissolve. If needed, repeat every 2 hours up to 4 times per day. If child is persistently irritable, wakeful and restless, administer 1 strip before bed - repeat if necessary or as directed by a healthcare professional." ], "stop_use": [ "Stop use and ask doctor if symptoms persist for more than 7 days or if irritation persists inflammation, fever or infection develops" ], "package_label_principal_display_panel": [ "Cherry Strip Carton FC79" ], "indications_and_usage": [ "Uses: Temporarily relieves minor irritation, pain and wakefulness associated with teething in infants." ], "set_id": "3715b3de-9afe-4280-ac9d-403acf5fd92e", "id": "5170ed26-40b2-47df-b7e3-8f0976abef2f", "active_ingredient": [ "Active Ingredients: Chamomilla (chamomile) 3X HPUS Coffea cruda (coffee seed) 3X HPUS Calcarea phosphorica (calcium phosphate) 12X HPUS" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Inactive ingredients citric acid, corn starch, crospovidone, D&C red 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "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 at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if 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 or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. 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 case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage." ], "questions": [ "Questions or comments? 1-866-467-2748" ], "spl_product_data_elements": [ "Premier Value Childrens Acetaminophen Melts Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CITRIC ACID MONOHYDRATE STARCH, CORN CROSPOVIDONE (15 MPA.S AT 5%) D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM ETHYLCELLULOSES FD&C BLUE NO. 1 GELATIN MALTODEXTRIN MAGNESIUM STEARATE SUCRALOSE RP080" ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease." ], "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 the right dose on chart. If possible, use weight to dose; otherwise, use age. • Chew before swallowing; this product will soften in mouth for ease of chewing • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tablets)* Under 24 Under 2 years ask a doctor 24-35 2-3 years 2 tablets 36-47 4-5 years 3 tablets 48-59 6-8 years 4 tablets 60-71 9-10 years years 5 tablets 72-95 11 6 tablets" ], "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." ], "storage_and_handling": [ "Other information • store at controlled room temperature 20-25ºC (68-77ºF). Avoid high humidity. Protect from light • see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child is allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "Product Packaging NDC 68016-196-00 Compare to Children's Tylenol® Meltaways® Active Ingredient* Premier Value Children's Pain Reliever Ages 2-6 ACETAMINOPHEN pain reliever/fever reducer Aspirin Free/ Ibuprofen Free GRAPE FLAVOR 30 count – 80mg each TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®. Premier Value Children's Pain Reliever" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: • the common cold • headache • flu • sore throat • toothache • temporarily reduces fever" ], "set_id": "37aed983-2698-42f6-aa66-36022462c488", "id": "37aed983-2698-42f6-aa66-36022462c488", "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 tablet) Acetaminophen 80 mg" ], "dosage_and_administration_table": [ "
Weight (lb) Age (yr) Dose (tablets)*
Under 24 Under 2 years ask a doctor
24-35 2-3 years 2 tablets
36-47 4-5 years 3 tablets
48-59 6-8 years 4 tablets
60-71 9-10 years years 5 tablets
72-95 11 6 tablets
" ] }, { "effective_time": "20130715", "inactive_ingredient": [ "Inactive ingredients Ethyl Palmate, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter), Beeswax (Cera Alba), Anthemis Nobilis Flower Oil (Chamomile), Punica Granatum Extract (Pomegranate), Punica Granatum Fruit Juice (Pomegranate), Tocopherol (Vitamin E), Glycerin (Palm), Gluconolactone, Sodium Benzoate, Maltodextrin, Silica." ], "instructions_for_use": [ "Directions apply liberally 15 minutes before sun sxposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 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 shirts, pants, hats, and sunglasses children under 6 months: ask a doctor" ], "purpose": [ "Purpose Sunscreen" ], "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 immediately." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Desert Essence Mineral Sunscreen SPF 35 Zinc Oxide ZINC OXIDE zinc oxide WATER SORBITAN OLIVATE SHEA BUTTER GLUCONOLACTONE GLYCERIN SODIUM BENZOATE TOCOPHEROL ALOE CALCIUM GLUCONATE POMEGRANATE JUICE MALTODEXTRIN SOYBEAN OIL SILICON DIOXIDE YELLOW WAX POMEGRANATE SUNFLOWER OIL CHAMOMILE FLOWER OIL ETHYL PALMITATE ETHYL OLEATE ETHYL LINOLEATE" ], "other_safety_information": [ "Other information protect this product container from excessive heat and direct sun" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use and ask a doctor Stop use and ask a doctor if rash occurs." ], "do_not_use": [ "Do not use Do not use on damaged or broken skin." ], "package_label_principal_display_panel": [ "Principal Display Panel image components 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": "39580856-ebee-4b20-a582-ddeefe5114da", "id": "fadc97b3-9d98-49ca-8151-4d4a1784843a", "active_ingredient": [ "Active Ingredient Zinc Oxide (15%)" ] }, { "effective_time": "20121116", "inactive_ingredient": [ "Inactive Ingredients Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin. *May also contain." ], "purpose": [ "Purpose Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Do not use Laxative products for longer than 1 week, unless directed by a doctor Ask a doctor befor use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Other Information each tablet contains: calcium 25 mg/tablet store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®" ], "questions": [ "Questions or Comments? Call toll free: 1877-753-3935 Monday-Friday 9AM - 5PM EST This product is not manufactured or distributed by Purdue Products, L.P., owner of th registered trademark Senokot. Proudly Distributed by Valu Merchandisers, Co. Kansas City, KS 66106" ], "spl_product_data_elements": [ "Good Neighbor Senna Sennosides SENNOSIDES A AND B SENNOSIDES A AND B CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES PARAFFIN MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL SILICON DIOXIDE STEARIC ACID SODIUM LAURYL SULFATE TALC TRIACETIN S3;S8;TCL080" ], "ask_doctor": [ "Ask a doctor befor use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that continues over a period of 2 weeks" ], "other_safety_information": [ "Other Information each tablet contains: calcium 25 mg/tablet store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®", "Other Information each tablet contains calcium 25mg store at 25C. excursions permitted between 15-30C (59-86F)" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions Take preferably at bedtime or as directed by a doctor. Age Starting Dosage Maximum Dosage adults and children 12 years of age or older 2tablets once a day 4 tablets twice a day children 6 to under 6 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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "package_label_principal_display_panel": [ "Product Labeling Good Neighbor Pharmacy Senna Lax Sennosides, 8.6mg Natural Laxative for Relief of Constipation Works naturally 100tablets gnsl" ], "indications_and_usage": [ "Uses: Relieves occasional constipation (irregularity) Generally produces a bowel movement in 6 - 12 hours" ], "set_id": "39f4f4b3-726a-41b4-9fb9-78e466bbfc0b", "id": "9089757d-2174-4deb-8d40-cd36418ac9b9", "active_ingredient": [ "Active Ingredient Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
Age Starting Dosage Maximum Dosage
adults and children 12 years of age or older 2tablets once a day 4 tablets twice a day
children 6 to under 6 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
" ] }, { "effective_time": "20111230", "inactive_ingredient": [ "Inactive ingredients D&C red #27 (al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol" ], "purpose": [ "Purpose Anti-diarrheal/Upset stomach reliever" ], "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 Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy Alert: Do not take if you are * allergic to salicylates (including aspirin) * taking other salicylate products Do not use * if you have bloody or black stool * if you have an ulcer or bleeding problem Ask a doctor before use if you have * fever * mucus in the stool" ], "spl_product_data_elements": [ "Peptic Relief Peptic Relief BISMUTH SUBSALICYLATE BISMUTH SUBSALICYLATE D&C RED NO. 27 CALCIUM CARBONATE DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN SILICON DIOXIDE SORBITOL LOGO;045" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions * drink plenty of clear fluids to help prevent dehydration caused by diarrhea * repeat dosage every 1/2 to 1 hour as needed * do not take more than 8 doses in 24 hours * use until diarrhea stops but not more than 2 days * adults and children 12 years and over: 2 tablets * children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts Ask a doctor or pharmacist before use if you are taking any drug for * anticoagulation (thinning the blood) * diabetes * gout * arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if * symptoms get worse * ringing in the ears or loss of hearing occurs * diarrhea lasts more than 2 days If pregnant or breast-feeding , ask a health professional before use.", "Other information * each tablet contains: calcium 77mg salicylate 102mg * store at 15°-30°C (59°-86°F) * protect from moisture", "Questions or comments? call 1-800-645-2158 , 9 am-5 pm EST, Monday-Friday." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Peptic Relief 262mg" ], "indications_and_usage": [ "Uses * Controls diarrhea * Relieves upset stomach due to overindulgence in food or drink" ], "set_id": "39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d", "id": "39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d", "active_ingredient": [ "Active ingredient Bismuth Subsalicytate 262mg" ] }, { "effective_time": "20131202", "inactive_ingredient": [ "Acetylatated Monoglycerine, Ammonium Glycyrrhizate, Croscarmellose Sodium, Ethylcellulose, Eudtagit E acrylic polymer, FD and C Red #40 Lake, Flavors, Fructose, Hydroxypropylcellulose, Hydroxypropylmethylcellulose, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Gluconate, Sodium Lauryl Sulfate, Soy Lecithin, Sucralose, Sugar, Vegetable Oil" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "purpose": [ "Purpose Antihistamine Nasal Decongestant" ], "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 two weeks after stopping the MAOI drug. If you do no know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "when_using": [ "When using this product do not exceed recommended dosage may cause excitability especially in children may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "DICEL Chlorpheniramine/Pseudoephedrine CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE FRUCTOSE CROSCARMELLOSE SODIUM MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS LECITHIN, SOYBEAN SUCRALOSE PALM KERNEL OIL SODIUM LAURYL SULFATE SUCROSE none" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma a sodium restricted diet trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not take more than 4 doses in 24 hours adults and children 12 years of age and over 2 chewables every 4 to 6 hours chlidren 6 to under 12 years of age one chewable every 4 to 6 hours children under 6 years of age consult 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 get nervous, dizzy, or sleeplessness occurs symptoms do not improve within 7 days, or are accompanied by fever" ], "package_label_principal_display_panel": [ "image of carton" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold, hay fever or other respiratory allergies Runny nose, sneezing, itching of the nose or throat, and itching watery eyes nasal congestion" ], "set_id": "3adcf527-ffce-46c5-bce0-df88f4016a2c", "id": "2a8ab738-d5d4-408d-94ba-f609eb95851f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each chewable) Chlorpheniramine Maleate 2mg Pseudoephedrine Hydrochloride 30mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 2 chewables every 4 to 6 hours
chlidren 6 to under 12 years of age one chewable every 4 to 6 hours
children under 6 years of age consult a doctor
" ] }, { "effective_time": "20131029", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Talc, PEG-8 Distearate, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Hydrated Silica, Maltodextrin, Gelatin Crosspolymer, Hydrolyzed Corn Starch, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "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 broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Adrenaline Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL PEG-8 DISTEARATE TALC STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz DegreeAdventurePDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "3b8b3072-cbef-458b-b8df-d94d00e453c9", "id": "5e6b27bd-5534-4a64-adb0-8c5dce944ff5", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20150116", "inactive_ingredient": [ "Inactive ingredients adipic acid, blue 1, dextrose, flavors, magnesium stearate, maltodextrin, red 27, starch, sucralose, yellow 6 lake, yellow 10 lake. Questions? 1-866-467-2748" ], "purpose": [ "Purpose Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 7 tablets in 24 hours if pregnant do not take more than 5 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor." ], "questions": [ "Questions? 1-866-467-2748" ], "spl_product_data_elements": [ "up and up ultra strength antacid Assorted Fruit Antacid Tablets CALCIUM CARBONATE CARBONATE ION CALCIUM CATION ADIPIC ACID FD&C BLUE NO. 1 DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN D&C RED NO. 27 STARCH, CORN SUCRALOSE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 RP103 assorted fruit" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor" ], "spl_unclassified_section": [ "Other information each tablet contains: elemental calcium 400mg store below 30°C (86°F)." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 11673-903-17 Compare to Tums Ultra®* ultra strength antacid 1000 calcium carbonate relief of heartburn, acid indigestion ,sour stomach and upset stomach associated with these symptoms ASSORTED FRUIT FLAVOR 160 TABLETS 160 CHEWABLE TABLETS naturally and artificially flavored 245 05 0457 R00 IDC-000274-01-007 Distributed by Target Corporation Minneapolis, MN 55403 ©2016 Target Brands, Inc. *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark Tums®. GLUTEN FREE Safety sealed: Do not use if printed seal under cap is torn or missing 100% satisfaction guaranteed or your money back. up and up ultra strength antacid 1000" ], "indications_and_usage": [ "Uses relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms" ], "set_id": "3bd4fc82-ce77-43e6-bc0c-bc9057b571c5", "id": "3bd4fc82-ce77-43e6-bc0c-bc9057b571c5", "active_ingredient": [ "Active ingredient (per tablet) Calcium Carbonate USP 1000mg" ] }, { "effective_time": "20121101", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium*, hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone*, sodium starch glycolate*, starch, stearic acid. *may contain" ], "purpose": [ "Purposes Pain reliever/ fever reducer Cough suppressant Expectorant 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." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing any of the above active ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful driving a motor vehicle or operating machinery Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days you get nervous, dizzy or sleepless cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-234-1464" ], "spl_product_data_elements": [ "Moore Medical MooreBrand Severe Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYPROMELLOSES POLYETHYLENE GLYCOLS STARCH, CORN STEARIC ACID white ROUND AZ;273" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59°-86°F (15°-30°C) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days you get nervous, dizzy or sleepless cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing any of the above active ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "425R Moore Medical Severe Cold Relief Label moore medical the supply experts® UPN# 0-0607415-87677-2 Moore Brand® Severe Cold relief Tablets Pseudoephedrine-Free 250 Packets/2 Tablets Each Packet Net Wt. 650 mg See new warnings information Reorder No. 87677 To Reorder: Call: 1.800.234.1464 Fax: 1.800.944.6667 Online: www.mooremedical.com Principal Display Panel - 425R Moore Medical Severe Cold Relief Label" ], "indications_and_usage": [ "Uses Temporarily relieves these cold symptoms cough sore throat minor aches and pains headache nasal congestion helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive Temporarily reduces fever." ], "set_id": "3caeb057-2e04-4f71-844a-45b5f7ce17f8", "id": "9e9262dc-4e3d-46c2-bb3c-0a6fb455a18c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active ingredients (in each tablet) Acetaminophen 325 mg Dextromethorphan Hydrobromide 15mg Guaifenesin 200mg Phenylephrine Hydrochloride 5mg" ] }, { "effective_time": "20140124", "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more 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." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more 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." ], "questions": [ "Questions or comments? 1-800-719-9260" ], "spl_product_data_elements": [ "APAP Arthitis Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POVIDONE STEARIC ACID TITANIUM DIOXIDE caplet L544" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole – do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F). see end panel for lot number and expiration date" ], "do_not_use": [ "Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Tylenol® Arthritis Pain active ingredient See New Warnings Information For the temporary relief of minor arthritis pain ASPIRIN FREE Pain Relief acetaminophen extended-release tablets, 650 mg pain reliever/fever reducer Arthritis Pain 650 mg each *Capsule-Shaped Tablets NDC 54868*-2801-0 image of package label Pain Relief Carton Image 1 Pain Relief Carton Image 2" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: arthritis the common cold headache toothache muscular aches backache menstrual cramps temporarily reduces fever" ], "set_id": "3d15a67f-963a-45fd-bf25-7762452f2dbd", "id": "bce0eae3-70df-43d8-8a1a-7b150dde95f5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredient (in each caplet) Acetaminophen 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole – do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age ask a doctor
" ] } ] }