{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 630 } }, "results": [ { "effective_time": "20140522", "inactive_ingredient": [ "Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate Questions or comments? Call 1-800-540-3765" ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to omeprazole Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus (immune system medicine) prescription antiretrovirals (medicines for HIV infection) S top use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-540-3765" ], "spl_product_data_elements": [ "QUALITY CHOICE OMEPRAZOLE omeprazole OMEPRAZOLE OMEPRAZOLE CARNAUBA WAX FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) LACTOSE MONOHYDRATE MONOETHANOLAMINE PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM STEARATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE capsule-shaped 20" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets Repeated 14-Day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition." ], "storage_and_handling": [ "Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) keep product out of high heat and humidity protect product from moisture" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 63868-170-42 QUALITY CHOICE Treats Frequent Heartburn! Occurring 2 or more days a week Omeprazole Delayed Release Tablets, 20mg Frequent Heartburn Relief Acid Reducer 42 Tablets Three 14-day courses of treatment omeprazole carton" ], "indications_and_usage": [ "Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect" ], "set_id": "0022ca14-9177-4fe9-90f3-1d67592d8d6c", "id": "a958dac3-8156-4222-a379-82fb3c229a74", "active_ingredient": [ "Active ingredient (in each tablet) Omeprazole delayed-release tablet, 20 mg" ] }, { "effective_time": "20120521", "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredients: Water, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Propylene Glycol, Sodium Chloride, DMDM Hydantoin, Glycerine, Tetrasodium EDTA, Fragrance, Methylchloroisothiazolinone, (and) Methyisothiazolinone, FDandC Yellow No.5, FDandC Red No.4" ], "purpose": [ "Purpose Antimicrobial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately." ], "warnings": [ "Warnings For external use only Do not use in or near eyes Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately." ], "when_using": [ "Do not use in or near eyes" ], "spl_product_data_elements": [ "Iris Antimicrobial Hand Chloroxylenol Chloroxylenol Chloroxylenol Water Sodium Lauryl Sulfate Cocamidopropyl Betaine Propylene Glycol Sodium Chloride DMDM Hydantoin Glycerin Edetate Sodium Methylchloroisothiazolinone Methylisothiazolinone FD&C Yellow No. 5 FD&C Red No. 4" ], "other_safety_information": [ "Other Information Store at room temperature" ], "openfda": {}, "version": "30025", "dosage_and_administration": [ "Directions Wet hands, dispense a small amount of soap, lather, rinse." ], "spl_unclassified_section": [ "SPL Unclassified Distributed by: Amerifoods Trading Co. P.O Box 512377 Los Angeles, CA 90051-0377 Product of U.S.A" ], "package_label_principal_display_panel": [ "image of label" ], "indications_and_usage": [ "Uses Antimicrobial Hand Soap" ], "set_id": "00cc5413-5fdb-4eed-bd1c-1e93e54e2578", "id": "c1ea512a-c605-46fb-9362-92eac215f01b", "active_ingredient": [ "Active Ingredient Chloroxylenol 0.3%" ] }, { "effective_time": "20150202", "inactive_ingredient": [ "INACTIVE INGREDIENTS: AQUA/WATER/EAU . CYCLOPENTASILOXANE . CYCLOMETHICONE . GLYCERIN . PEG/PPG-20/15 DIMETHICONE . CETYL DIMETHICONE . METHYL METHACRYLATE CROSSPOLYMER . SODIUM CHLORIDE . TALC . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE . ALUMINUM HYDROXIDE . STEARIC ACID . PARFUM/FRAGRANCE . PPG-3 MYRISTYL ETHER PEG-10 DIMETHICONE . DISTEARDIMONIUM HECTORITE . DISODIUM STEAROYL GLUTAMATE . SILICA . DIMETHICONE CROSSPOLYMER . ETHYLHEXYLGLYCERIN . PENTYLENE GLYCOL . DIMETHICONOL . DISODIUM EDTA . BUTYLENE GLYCOL . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . PINUS PINASTER BARK EXTRACT . THERMUS THERMOPHILLUS FERMENT . BIOSACCHARIDE GUM-4 . TRIETHOXYCAPRYLYLSILANE . RHODIOLA ROSEA ROOT EXTRACT . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . SODIUM LAURYL SULFATE . ECLIPTA PROSTRATA EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . PHENOXYETHANOL . SORBIC ACID . POTASSIUM SORBATE . BHT. ± / MAY CONTAIN/PEUT CONTENIR: [CI 77891/TITANIUM DIOXIDE . CI 77491/ CI 77492/CI 77499/IRON OXIDES . CI 77019/MICA]." ], "warnings": [ "WARNING: for external use only, not to be swallowed." ], "when_using": [ "Avoid contact with eyes." ], "spl_product_data_elements": [ "Super Restorative Foundation True Lift SPF 15 Tint 09 TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 CYCLOMETHICONE GLYCERIN SODIUM CHLORIDE TALC ALUMINUM HYDROXIDE STEARIC ACID PPG-3 MYRISTYL ETHER DISODIUM STEAROYL GLUTAMATE SILICON DIOXIDE ETHYLHEXYLGLYCERIN PENTYLENE GLYCOL EDETATE DISODIUM BUTYLENE GLYCOL MARITIME PINE TRIETHOXYCAPRYLYLSILANE LAPSANA COMMUNIS FLOWERING TOP SODIUM LAURYL SULFATE GREEN TEA LEAF PHENOXYETHANOL SORBIC ACID POTASSIUM SORBATE BUTYLATED HYDROXYTOLUENE MICA" ], "description": [ "An exceptional foundation that lifts and evens the complexion and covers imperfections. Its full-coverage formula and creamy texture gives the complexion aflawless, radiant appearance with a soft, vibrant, youthful glow. Clarins: make-up that cares for your skin. Non-comedogenic. Allergy tested. Expertise 3P. Protects skin from the harmful effects of today's pollution. Foundation mit \"Lifting\"-Effekt SPF 15 ref. 401401" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DIRECTIONS: apply liberally. Reapply as needed." ], "stop_use": [ "Discontinue use if signs of irritation or rash appear." ], "package_label_principal_display_panel": [ "09 ref. 401401 Cappuccino", "CLARINS PARIS SPF 15 Super Restorative Foundation True Lift - Apply with fingertips. \"Anti-Pollution\" protection. Allergy tested, non-comedogenic. Directions: see outer carton. WARNING: for external only, not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. ACTIVE INGREDIENT: TITANIUM DIOXIDE 2, 5 % Dist. in CLARINS CANADA INC. 815 Desserte est Autoroute Chomedey Laval (Quebec) H7W 5N4. Made in France CLARINS PARIS - 92200 Neuilly France 95300 Pontoise 30 mL 1.06 Oz. Net Wt. 12 M", "CLARINS PARIS 09 SPF 15 Super Restorative Foundation True Lift e 30 mL 1.06 Oz. Net Wt.", "Clarins Super Restorative Foundation True Lift Cappuchin 09", "Clarins Super Restorative Foundation True Lift Inner", "Clarins Super Restorative Foundation True Lift Outer 09" ], "set_id": "017baace-9265-4b6d-97ec-c1c86fe1d46d", "id": "4213bab9-1dda-4ef4-a0b3-a1de0674eaa1", "description_table": [ "
Expertise 3P. Protects skin from the harmful effects of today's pollution.
" ], "active_ingredient": [ "ACTIVE INGREDIENT: TITANIUM DIOXIDE 2, 5 %" ] }, { "effective_time": "20150115", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "AmerFresh Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Calcium Carbonate Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Saccharin Sodium Methylparaben Sodium Propylparaben Sodium AmerFresh Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion Calcium Carbonate Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Saccharin Sodium Methylparaben Sodium Propylparaben Sodium" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist" ], "spl_unclassified_section": [ "Drug Facts", "Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112 AMERFRESH ® FLUORIDE TOOTHPASTE NET WT. 3 oz (85g) PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112", "PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114 AMERFRESH ® FLUORIDE TOOTHPASTE NET WT. 3 oz (85g) PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1113" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "018990a8-bcc7-43f9-928e-db937f5705bc", "id": "26239955-403c-4dcd-9e8e-0b36d44a7e01", "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)" ] }, { "effective_time": "20101026", "inactive_ingredient": [ "Inactive ingredients sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, SD alcohol 38-B, flavor, cellulose gum, sodium saccharin, mica, red 40, red 33, titanium dioxide" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-5135 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "CLOSE UP Claiente Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA PEG-32 STEARATE SODIUM LAURYL SULFATE ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM DIHYDRATE MICA FD&C RED NO. 40 D&C RED NO. 33 TITANIUM DIOXIDE Cinnamon Blast Red" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "ANTICAVITY FLUORIDE TOOTHPASTE CLOSE UP with Breath Freshening Sparkle formula! Caliente! High-Impact CINNAMON flavor NET WT. 4.0 OZ. (113.4g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "022b7cac-bd18-4acc-94b0-5aa609660d76", "id": "5f344954-cca8-4c5e-b57b-8aa58203349e", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20141229", "inactive_ingredient": [ "Inactive ingredients Water, TEA-Dodecylbenzenesulfonate, Sodium Laureth Sulfate, Sodium Methyl 2-Sulfopalmitate, Lauramine Oxide, Sodium Lauryl Sulfate, Alcohol Denat., Disodium 2-Sulfopalmitate, Methyl Palmitate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Red No. 33" ], "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. In case of eye contact, rinse thoroughly with water." ], "purpose": [ "Antibacterial hand soap" ], "warnings": [ "For external use only" ], "questions": [ "Questions or comments about this product? 1-800 Wegmans (934-6267) Ext 5920 9am - 4pm EST weekdays Visit us at wegmans.com" ], "spl_product_data_elements": [ "Wegmans Ultra Dishwashing Orange Scent Triclosan TRICLOSAN TRICLOSAN WATER TRIETHANOLAMINE DODECYLBENZENESULFONATE SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE ALCOHOL LAURAMINE OXIDE DISODIUM 2-SULFOPALMITATE METHYL PALMITATE EDETATE SODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SULISOBENZONE FD&C YELLOW NO. 5 D&C RED NO. 33" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wash hands and rinse" ], "package_label_principal_display_panel": [ "LBLFR LBLBK front label back label" ], "indications_and_usage": [ "Use helps fight germs on hands when used as a hand soap" ], "set_id": "02305acf-d402-4849-a259-3d095e53b8b9", "id": "7cf76aa8-7614-48e3-8734-235b16871338", "active_ingredient": [ "Active ingredient Triclosan 0.10% Use helps fight germs on hands when used as a hand soap For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. In case of eye contact, rinse thoroughly with water. Directions wash hands and rinse Antibacterial hand soap Inactive ingredients Water, TEA-Dodecylbenzenesulfonate, Sodium Laureth Sulfate, Sodium Methyl 2-Sulfopalmitate, Lauramine Oxide, Sodium Lauryl Sulfate, Alcohol Denat., Disodium 2-Sulfopalmitate, Methyl Palmitate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Red No. 33 Questions or comments about this product? 1-800 Wegmans (934-6267) Ext 5920 9am - 4pm EST weekdays Visit us at wegmans.com" ] }, { "effective_time": "20101116", "inactive_ingredient": [ "Inactive ingredients water, glycerin, sorbitol, hydrated silica, poloxamer 407, sodium bicarbonate, PEG-32, sodium lauryl sulfate, SD alcohol 38-B, zinc citrate trihydrate, flavor, hydrogen peroxide, cellulose gum, sodium saccharin, phosphoric acid, titanium dioxide, blue 1, yellow 5" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "Mentadent Advanced Care Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN SORBITOL HYDRATED SILICA POLOXAMER 407 SODIUM BICARBONATE PEG-32 STEARATE SODIUM LAURYL SULFATE ALCOHOL ZINC CITRATE HYDROGEN PEROXIDE CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM DIHYDRATE PHOSPHORIC ACID TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Refreshing Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions supervise children as necessary until capable of using without supervision do not swallow adults and children 2 years and older brush teeth thoroughly preferable after each meal or at least twice a day, or as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to reduce swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel MENTADENT Anticavity Fluoride Toothpaste Baking Soda and Peroxide Advanced Care Clean Mint NET WT. 5.25 OZ. (148.8g) for HEALTHY TEETH and GUMS 1 REFILL 50% MORE than regular size pump Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "026250ae-5aac-44fa-87d3-c67225573cc0", "id": "cca4ba8c-1ff6-47a7-9795-7834691d5ad7", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20141022", "inactive_ingredient": [ "Inactive Ingredients (advanced 2x enamel) water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, carbomer, sodium saccharin, carrageenan gum, sodium hydroxide, blue 1 lake, red 30" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings When using this product, if irritation occurs discontinue use Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product, if irritation occurs discontinue use" ], "questions": [ "Questions or comments? call toll-free 1-800-897-5623 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "AQUAFRESH ADVANCED 2X ENAMEL sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA SORBITOL GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE XANTHAN GUM TITANIUM DIOXIDE SACCHARIN SODIUM CARRAGEENAN SODIUM HYDROXIDE FD&C BLUE NO. 1 ALUMINUM OXIDE D&C RED NO. 30" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • adults and children 2 years and older: • apply toothpaste onto a toothbrush • brush teeth thoroughly, preferably after each meal, at least twice a day, and not more than 3 times a day, or use as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. • to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established • children under 2 years consult a dentist or doctor" ], "storage_and_handling": [ "Other information • store below 30°C (86°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0498-04 Aquafresh ® FLUORIDE TOOTHPASTE TRIPLE PROTECTION ® advanced FIVE PACK 5/6.7OZ TUBES (189.9G EACH TOTAL NET WT. 33.5 OZ (948.G) STRENGTHENS WEAKENED TOOTH ENAMEL IN JUST 14 DAYS* • FIGHTS CAVITIES • PROMOTES HEALTHY GUMS • HELPS LOCK IN VITAL MINERALS • HELPS LOCK OUT PLAQUE ACIDS • GENTLY WHITENS • FRESHENS BREATH *Use as directed. 100620PA Aquafresh Advanced 5 pack label" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "02678a35-79f0-445c-b423-cda74ebd6af2", "id": "02678a35-79f0-445c-b423-cda74ebd6af2", "active_ingredient": [ "Active ingredient Sodium fluoride (0.15% w/v fluoride ion)" ] }, { "effective_time": "20130111", "inactive_ingredient": [ "Inactive ingredients calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "AmerFresh Sodium Monofluorophosphate Sodium Monofluorophosphate Fluoride Ion calcium carbonate carboxymethylcellulose sodium saccharin sodium sodium lauryl sulfate hydrated silica methylparaben sodium propylparaben sodium" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For Use wet toothbrush and dip into powder until brush is fully covered brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly Do not swallow supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist" ], "spl_unclassified_section": [ "Drug Facts", "Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 57 g Packet Label AMERFRESH ® FLUORIDE TOOTHPOWDER NET WT. 2 oz (57g) PRINCIPAL DISPLAY PANEL - 57 g Packet Label" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "02ae9422-6c06-4c91-ac42-de7368825e5b", "id": "c4e05d34-45f9-4883-9238-628b1562a55b", "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)" ] }, { "spl_product_data_elements": [ "Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION GLYCERIN HYDRATED SILICA WATER SODIUM BICARBONATE POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE SODIUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CARRAGEENAN SACCHARIN SODIUM TITANIUM DIOXIDE FD&C GREEN NO. 3" ], "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)" ], "purpose": [ "Purpose Anticavity" ], "indications_and_usage": [ "Use helps protect against cavities" ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician." ], "inactive_ingredient": [ "Inactive ingredients glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C green no. 3" ], "questions": [ "Questions? 1-800-468-6502 www.colgate.com" ], "spl_unclassified_section": [ "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 79 g Tube Label Colgate ® Fluoride Toothpaste Mint Zing Paste SPARKLING WHITE ® with Baking Soda & Peroxide WHITENS & PROTECTS TEETH FROM STAINS NET WT 2.8 OZ (79 g) Principal Display Panel - 79 g Tube Label" ], "set_id": "02dd29a2-ecd8-4252-9973-ecee66054e95", "id": "9bd8f953-906c-4f05-8ae6-ca928c8edca0", "effective_time": "20130130", "version": "3", "openfda": {} }, { "effective_time": "20150511", "inactive_ingredient": [ "Inactive Ingredients Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, methacrylic acid copolymer, sodium lauryl sulfate, polysorbate, triethyl citrate, titanium dioxide, talc, FD&C Yellow No.5, Aluminum Oxide" ], "purpose": [ "Purpose Pain 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: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for • gout • diabetes • arthritis Stop use and ask a doctor if • an allergic reaction occurs. Seek medical right away. • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better o pain gets worse or lasts more than 10 days o redness or swelling is present o new symptoms occur o ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "questions": [ "Questions or comments? Call toll free 1-888-952-0050 Monday through Friday 9AM-5PM *Health A2Z ® Aspirin is not manufactured or distributed by Bayer Consumer Care, distributor of Bayer® Manufactured for: A&Z Pharmaceutical Inc. Deer Park, NY11729" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN STARCH, PREGELATINIZED CORN CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE STEARIC ACID HYPROMELLOSES METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SODIUM LAURYL SULFATE POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE TALC FD&C YELLOW NO. 5 ALUMINUM OXIDE A" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions • drink a full glass of water with each dose • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor • children under 12 years: consult a doctor" ], "spl_unclassified_section": [ "Other Information • save carton for full directions and warnings • store at room temperature" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Aspirin (NSAID) 81 mg label" ], "indications_and_usage": [ "Uses Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Ask your doctor about other uses for Enteric Coated 81 mg Aspirin." ], "set_id": "036bb237-ac24-4eab-b0f2-61eb3824f830", "id": "302f81e2-345d-47c6-90a5-de1d0b9cf014", "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151230", "inactive_ingredient": [ "INACTIVE INGREDIENTS: SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT." ], "keep_out_of_reach_of_children": [ "WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD." ], "purpose": [ "PURPOSE: ANTICAVITY" ], "warnings": [ "WARNINGS: IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "spl_product_data_elements": [ "Go Smile PM SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE SODIUM BENZOATE SACCHARIN SODIUM VALERIAN" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "DIRECTIONS: ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS. INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR." ], "package_label_principal_display_panel": [ "GO SMiLE PM 1.0 ozTube_V5_7_11 GO SMiLE PM 3.5 ozTube_V4_7_11" ], "indications_and_usage": [ "PURPOSE: ANTICAVITY" ], "set_id": "03eb5f93-d683-4a7c-9946-051a8960804e", "id": "a301581f-f1c8-4739-9992-80d9096e3604", "active_ingredient": [ "ACTIVE INGREDIENTS: SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE 2 IN 1 DANDRUFF GREEN APPLE PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE DIMETHICONE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE SODIUM XYLENESULFONATE CETYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) SODIUM CHLORIDE MAGNESIUM SULFATE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL ALMOND OIL CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "040315ce-0bd9-4ad9-85a7-048879ff4381", "id": "b27e7eff-8fd5-47e1-bdb8-3ff137ff1e8c", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20140815", "inactive_ingredient": [ "Inactive ingredients (Fresh Impact) water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, blue 1", "Inactive ingredients (Deep Impact) water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, blue 1, yellow 10", "Inactive ingredients (Lasting Impact) water, sorbitol, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, isopentane, flavor, carrageenan gum, xanthan gum, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, sucralose, FD&C blue #1, D&C yellow #10", "Inactive ingredients (Pure Breath) water, hydrated silica, glycerin, sorbitol, PEG-8, sodium citrate, sodium lauryl sulfate, isopentane, flavor, carrageenan, xanthan gum, zinc chloride, sodium saccharin, citric acid, blue 1" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Flammable. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 o F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal." ], "warnings": [ "Warnings When using this product, if irritation occurs discontinue use Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Flammable. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 o F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal." ], "when_using": [ "When using this product, if irritation occurs discontinue use" ], "questions": [ "Questions or comments? call toll-free 1-800-897-5623 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "AQUAFRESH iso-active sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE PEG-8 LAURATE SODIUM LAURYL SULFATE ISOPENTANE CARRAGEENAN XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM HYDROXIDE SACCHARIN SODIUM FD&C BLUE NO. 1 greenish blue AQUAFRESH iso-active sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE PEG-8 LAURATE SODIUM LAURYL SULFATE ISOPENTANE CARRAGEENAN XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM HYDROXIDE SACCHARIN SODIUM SUCRALOSE D&C YELLOW NO. 10 FD&C BLUE NO. 1 greenish blue AQUAFRESH iso-active sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL GLYCERIN HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE PEG-8 LAURATE SODIUM LAURYL SULFATE ISOPENTANE CARRAGEENAN XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM HYDROXIDE SACCHARIN SODIUM SUCRALOSE FD&C BLUE NO. 1 D&C YELLOW NO. 10 greenish blue AQUAFRESH iso-active sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA GLYCERIN SORBITOL POLYETHYLENE GLYCOL 400 SODIUM CITRATE SODIUM LAURYL SULFATE ISOPENTANE CARRAGEENAN XANTHAN GUM ZINC CHLORIDE SACCHARIN SODIUM CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "Directions • adults and children 2 years of age and older: • apply toothgel onto a toothbrush • brush teeth thoroughly, preferably after each meal, at least twice a day, and not more than 3 times a day, or use as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. • to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing and rinsing until good habits are established • children under 2 years of age: consult a dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0505-01 Aquafresh ® triple protection® fluoride toothgel iso-active ® FOAMING GEL fresh impact ® +whitening healthy gums strong teeth fresh breath NET WT 4.3 oz (121.6g) triple protection® strong healthy teeth for a lifetime To clean, wipe nozzle without water. Do not remove nozzle healthy gums strong teeth fresh breath with regular brushing Aquafresh iso-active ® Whitening Deep Impact ® toothgel is a distinctive refreshing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth ALWAYS FOLLOW THE LABEL. AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies. Best before: see base of can. RECYCLING INFORMATION: Please recycle – when empty. Does not contain CFCs. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Taiwan www.Aquafresh.com ©2012 GlaxoSmithKline 102150XA Aquafresh IsoActive Whitening Fresh Impact 4.3 oz label", "Principal Display Panel NDC 0135-0504-01 Aquafresh ® triple protection® fluoride toothgel iso-active ® FOAMING GEL deep impact ® +whitening healthy gums strong teeth fresh breath NET WT 4.3 oz (121.6g) triple protection® strong healthy teeth for a lifetime To clean, wipe nozzle without water. Do not remove nozzle healthy gums strong teeth fresh breath with regular brushing Aquafresh iso-active ® Whitening Deep Impact ® toothgel is a distinctive flavor invigorating experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected whiter teeth ALWAYS FOLLOW THE LABEL. AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies. Best before: see base of can. RECYCLING INFORMATION: Please recycle – when empty. Does not contain CFCs. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Taiwan www.Aquafresh.com ©2012 GlaxoSmithKline 102149XA Aquafresh IsoActive Whitening Deep Impact 4.3 oz label", "Principal Display Panel Lasting Impact NDC 0135-0506-01 Aquafresh ® FLUORIDE TOOTHGEL iso-active ® WHITENING FOAMING GEL LASTING IMPACT TM TRIPLE PROTECTION® HEALTHY GUMS STRONG TEETH FRESH BREATH NET WT 4.3 oz (121.6g) For best results, wipe nozzle before and after each use. AQUAFRESH ® TOOTHPASTE WITH TRIPLE PROTECTION ® BENEFITS HEALTHY GUMS STRONG TEETH FRESH BREATH Aquafresh iso-active ® Whitening Lasting Impact TM , a distinctive energizing flavor experience. It penetrates hard to reach places in your mouth and actively breaks down stains when you brush, leaving behind healthy, protected white teeth while also helping to maintain healthy gums. Aquafresh ® , iso-active ® , Lasting Impact TM and the three striped logo are trademarks of the GlaxoSmithKline group of companies. Best before: see base of can. RECYCLING INFORMATION: Please recycle – when empty. Does not contain CFCs. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Taiwan www.Aquafresh.com ©2010 GlaxoSmithKline 53996XC Aquafresh Lasting Impact Label", "Principal Display Panel Pure Breath Action NDC 0135-0524-01 Aquafresh ® fluoride toothgel triple protection® iso-active ® FOAMING GEL EXTREME CLEAN WITH MICRO-ACTIVE FOAMING ACTION + WHITENING *Immediately after brushing versus a zinc free toothpaste pure breath action for 80% cleaner, purer breath* strong healthy teeth for a lifetime fresh mint NET WT 4.3 OZ (121.6g) To clean, wipe nozzle without water. Do not remove nozzle. triple protection ® healthy gums strong teeth fresh breath with regular brushing Aquafresh ® Extreme Clean ® Pure Breath Action iso-active ® toothgel transforms into a micro-active foam to get to hard to reach places in your mouth. As you brush, the unique mineral containing formula neutralizes bad breath odors for 80% cleaner, purer breath*. Take the Feeling of Clean to the Extreme! ® ALWAYS FOLLOW THE LABEL AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device and other marks are trademarks of the GlaxoSmithKline group of companies. Best before: see base of can. RECYCLING INFORMATION: Please recycle - when empty. Does not contain CFCs. DOT-2P M5706 Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Germany www.Aquafresh.com ©2012 GlaxoSmithKline 102151XA Aquafresh IsoActive Pure Breath Extreme Clean 4.3oz (121.6g) label" ], "indications_and_usage": [ "Use aids in the prevention of dental cavities" ], "set_id": "047f5ec4-42bb-4d21-b78d-71ba7159d53a", "id": "b539fc3b-61c7-40f4-81d6-0a447e617626", "active_ingredient": [ "Active ingredient Sodium fluoride (0.15% w/v fluoride ion)" ] }, { "effective_time": "20110321", "inactive_ingredient": [ "Inactive Ingredients: Sorbitol, Hydrated Silica, Water, PEG-6, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Titanium Dioxide, Sodium Phosphate, Sodium Saccharin" ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Western Family Cavity Control Sodium Fluoride Sodium Fluoride Fluoride Ion SORBITOL SILICON DIOXIDE WATER POLYETHYLENE GLYCOL 300 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE TITANIUM DIOXIDE SODIUM PYROPHOSPHATE SACCHARIN SODIUM Cool Fresh Paste" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children Brush teeth throughly, preferably after 2 years and older each meal, or at least twice a day, or as directed by your dentist. Do not swallow. Children under To minimize swallowing, use a pea-sized 6 years of age amount and supervise brushing until good habits are established. Children under 2 years Ask a dentist or physician." ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "Helps protect against cavities." ], "set_id": "04de1ef4-3212-4998-bd5e-f2fb556637b3", "id": "62798515-110d-472f-a027-11cc75387654", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste" ] }, { "effective_time": "20120321", "inactive_ingredient": [ "Inactive Ingredients Water, Sodium Lauryl Sulfate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice, Sodium Chloride, Citric Acid." ], "purpose": [ "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only . Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention." ], "questions": [ "Questions or comments? 1-800-GO-BENCO www.benco.com" ], "spl_product_data_elements": [ "natural extensions Antibacterial Liquid Hand Wash TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURYL SULFATE COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE GLYCERIN DMDM HYDANTOIN ALOE VERA LEAF SODIUM CHLORIDE CITRIC ACID MONOHYDRATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Wet hands. Apply liberal amount of product. Rub hands together for 30 seconds. Rinse thoroughly." ], "spl_unclassified_section": [ "natural extensions Antibacterial Liquid Hand Soap Earth-friendly Natural Extensions Antibacterial Liquid Hand Soap contains vegetable-based glycerin, soothing aloe and other natural ingredients, making it more environmentally sensitive than petroleum-based products. Non-irritating formula Bio-based pH balanced with natural moisturizers and aloe Supremely powerful antibacterial action Soft, rich lather Mild detergents" ], "stop_use": [ "Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours." ], "storage_and_handling": [ "Other Information Keep from freezing" ], "package_label_principal_display_panel": [ "500 ml Pump Bottle 500 ml Pump Bottle" ], "indications_and_usage": [ "Uses For handwashing to decrease bacteria on the skin." ], "set_id": "05b3ee4c-d9dc-412d-88f0-1d861648a96b", "id": "c7945e12-602e-451d-aac1-758f0f7de625", "active_ingredient": [ "Active Ingredient Triclosan.3%" ] }, { "effective_time": "20151127", "inactive_ingredient": [ "Inactive ingredients Water (Aqua), Sorbitol, Alcohol (21.6%), Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090)." ], "purpose": [ "Purpose Antigingivitis/Antiplaque" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately" ], "warnings": [ "Warnings Do not use in children under 12 years of age Keep out of reach of children If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately" ], "questions": [ "Questions or comments? 1-800-289-8343" ], "spl_product_data_elements": [ "HYVEE COMPLETE CARE FRESH MINT SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL ALCOHOL POLOXAMER 407 SODIUM LAURYL SULFATE EUCALYPTOL METHYL SALICYLATE THYMOL PHOSPHORIC ACID SUCRALOSE MENTHOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C RED NO. 40 FD&C BLUE NO. 1" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night Do not swallow" ], "storage_and_handling": [ "Other information Store at room temperature Cold weather may cloud this product. Its antiseptic properties are not affected." ], "package_label_principal_display_panel": [ "Label Copy Image of the label" ], "indications_and_usage": [ "Uses to help reduce and prevent plaque gingivitis" ], "set_id": "06c7ee9c-f8d6-4039-add9-193ea44f2b6d", "id": "2dd7bcd9-ec57-4b39-974c-9cd8166e1c3a", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.02% (0.01% w/v Fluoride ion) Purpose Antigingivitis/Antiplaque" ] }, { "effective_time": "20151029", "inactive_ingredient": [ "Inactive ingredients cellulose, citric acid, dibasic sodium phasphate, hydrogenated vegetable oil, hypromellose, propylene glycol, simethicone, sodium lauryl sulfate, starch, talc, titanium dioxide, magnesium carbonate, calcium carbonate, magnesium oxide." ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or fly-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 facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs symptoms do not improve new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days 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. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Buffered Aspirin Aspirin ASPIRIN ASPIRIN CITRIC ACID MONOHYDRATE HYPROMELLOSES PROPYLENE GLYCOL DIMETHICONE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE MAGNESIUM CARBONATE CALCIUM CARBONATE MAGNESIUM OXIDE 44;183" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "Directions adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor. Children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use 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 you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs symptoms do not improve new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablet contains : calcium 35 mg and magnesium 40 mg store at controlled room temperature 15º-30ºC (59º-86ºF) see end flag for expiration date and lot number" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel RITE AID® PHARMACY **Compare to the active ingredient in Bufferin® REGULAR STRENGTH pain relief buffered aspirin tri-buffered aspirin, 325 mg pain reliever • fever reducer (NSAID) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 ORG111018330 DISTRIBUTED BY: Rite Aid, 30 Hunter Lane Camp Hill, PA 17011 Product Packaging" ], "indications_and_usage": [ "Use(s) temporarily relieves minor aches and pains associated with: headache backache muscular aches minor pain of arthritis toothache the common cold premenstrual & menstrual cramps temporarily reduces fever" ], "set_id": "07a563a2-2a0e-4fac-8952-abd1bf281988", "id": "fe95e2a2-d382-403b-aad0-705329005a60", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient(s) Buffered aspirin equal to 325 mg aspirin (NSAID)* (buffered with magnesium carbonate, calcium carbonate and magnesium oxide) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151223", "inactive_ingredient": [ "Inactive ingredients Croscarmellose sodium, Dicalcium Phosphate, FD&C Yellow #5,Lake, FD&C Yellow #6 Lake, Hydroxypropylmethylcellulose, Magensium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Sodium Lauryl Sulfate, Starch, Stearic cid and Titanium Dioxide." ], "purpose": [ "Purpose" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poision Control Center right away." ], "warnings": [ "Warnings Do not use for longer than one week, when abdominal pain, nausea or vomiting are present." ], "spl_product_data_elements": [ "Senna Plus Senna Plus CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM ALUMINUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS SODIUM BENZOATE SODIUM LAURYL SULFATE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE SENNOSIDES SENNOSIDES DOCUSATE SODIUM DOCUSATE CPC490" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Take preferably at bedtime or as directed by a doctor, if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable age starting dose maximum dose adults and children over 12 years 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding, you fail to have a bowel movement after use of this product, may indicate a serious condition. You may report side effects to FDA at 1-800-FDA-1088." ], "storage_and_handling": [ "Store at controlled room temperature 20°C to 25°C (68°-77°F), excursions permitted to 15°C to 30°C (598°-86°F). Mfg by Contract Pharmacal Corp Hauppauge, NY 11788 USA www.CPCHealth.com" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Senna Plus Carton Label" ], "indications_and_usage": [ "Uses For the short term relief of constipation, produce bowel movement in 6 to 12 hours." ], "set_id": "07beb7c7-af12-48a3-ae0f-fce96ce1fca8", "id": "2794d704-947c-195f-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks" ], "active_ingredient": [ "Active ingredient Sennosides form Senna Concentrate 8.6mg Sodium Dioctylsulfosuccinate 50 mg" ], "dosage_and_administration_table": [ "
age starting dose maximum dose
adults and children over 12 years 2 tablets once a day 4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor
" ] }, { "effective_time": "20141115", "inactive_ingredient": [ "aloe barbadensis leaf, water, arnica montan extract, boswella serrata extract, camelia sinensis leaf extract, carbomer, ethylhexylglycerine, glycerine, isopropyl myristate, PEG 8, phenoxyethanol, polysorbate 80, sodium lauryl sulfate, triethanolamine, fd&c blue #1, fd&c yellow #5" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "purpose": [ "Topical anesthetic External analgesic" ], "spl_product_data_elements": [ "Lidenza Patch Lidocaine Hydrochloride WATER GLYCERIN ARNICA MONTANA POLYSORBATE 80 ALOE VERA LEAF BOSWELLIA SACRA WHOLE GREEN TEA LEAF CARBOMER 1342 ETHYLHEXYLGLYCERIN ISOPROPYL MYRISTATE PEG-8 GLYCERYL ISOSTEARATE PHENOXYETHANOL SODIUM LAURYL SULFATE TRIETHANOLAMINE BENZOATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS MENTHOL MENTHOL" ], "warnings_and_cautions": [ "Warnings For external use only Avoid contact with eyes Do not applly to open wounds or damaged skin If symptoms persist for more than seven days, discontinue use and consult physician If swallowed, consult physician Do not bandage tightly If pregnant or breast feeding, contact physician prior to use Do not use in large quantities, particularly over raw surfaces or blistered areas" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "clean and dry affected area remove patch from backing and apply to affected area use only one patch at a time, and maximum of four patches/day leave patch on affected area for up to 8 hours do not use patches for longer than five consecutive days children under 12 should consult physician prior to use" ], "package_label_principal_display_panel": [ "Lidenza Patch box image" ], "indications_and_usage": [ "Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations" ], "set_id": "07e9972b-b74b-4eb5-e054-00144ff88e88", "id": "07e9972b-b74c-4eb5-e054-00144ff88e88", "active_ingredient": [ "Lidocaine HCL 4.00% Menthol 1.00%" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "080f0e07-6004-40fe-868f-4e4da7fcf1f1", "id": "1fcccdd5-4dd6-43fd-a8f3-0c32bb897587", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20141118", "inactive_ingredient": [ "Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5." ], "purpose": [ "Purpose Topical Analgesic External Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, consult physician." ], "warnings": [ "Warnings For external use only Avoid contact with eyes Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, consult physician. Do not bandage tightly If pregnant or breast feeding, contact physician prior to use. Do not use in large quantities, particularly over raw surfaces or blistered areas." ], "spl_product_data_elements": [ "Lidonexe LIDOCAINE, MENTHOL INDIAN FRANKINCENSE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS MENTHOL MENTHOL GREEN TEA LEAF ETHYLHEXYLGLYCERIN GLYCERIN ISOPROPYL MYRISTATE POLYETHYLENE GLYCOL 400 PHENOXYETHANOL POLYSORBATE 80 SODIUM LAURYL SULFATE TROLAMINE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ARNICA MONTANA ALOE VERA LEAF water" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches/day. Leave patch on affected area for up to 8-hours. Do not use patches for longer than five consecutive days. Children under 12 should consult physician prior to use." ], "spl_unclassified_section": [ "Lidonexe Patch" ], "storage_and_handling": [ "Store below 25 degrees. Avoid direct sunlight." ], "package_label_principal_display_panel": [ "Lidonexe 25 patches (69329 -002-25) lindonexe_label_small.jpg" ], "indications_and_usage": [ "Uses: For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations." ], "set_id": "081c276b-f715-081e-e054-00144ff88e88", "id": "081c276b-f716-081e-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients: Lidocaine HCL 4.00% Menthol 1.00%" ] }, { "effective_time": "20110110", "inactive_ingredient": [ "Inactive Ingredients: Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carageenan, Mica, FDC Blue No.1." ], "purpose": [ "" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Western Family Complete Whitening Sodium Fluoride Sodium Fluoride Fluoride Ion SORBITOL SILICON DIOXIDE WATER GLYCERIN SODIUM LAURYL SULFATE ZINC CITRATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM BENZOATE SODIUM PYROPHOSPHATE SACCHARIN SODIUM SODIUM HYDROXIDE CARRAGEENAN MICA FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Adults and children Brush teeth throughly, preferably after 6 years and older each meal, or at least twice a day, or as directed by your dentist. Do not swallow. Children between To minimize swallowing, use a pea-sized 6 and 12 years amount and supervise brushing until good habits are established. Children under 6 years Ask a dentist or physician." ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "Helps protect against cavities." ], "set_id": "082d3822-cd16-4394-9aca-e4753fd8e610", "id": "e9de92b1-628f-4d40-b8f9-e4957827d8c7", "active_ingredient": [ "Active Ingredient Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste" ] }, { "effective_time": "20140307", "inactive_ingredient": [ "Inactive ingredients WATER, PPG-15 STEARYL ETHER, GLYCERIN, STEARYL ALCOHOL, CETYL BETAINE, DISTEARYLDIMONIUM CHLORIDE, SODIUM LAURYL SULFATE, OXIDIZED POLYETHYLENE, CETYL ALCOHOL, STEARETH-21, BEHENYL ALCOHOL, PPG-30, STEARETH-2, FRAGRANCE, DISODIUM EDTA." ], "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 avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. using other topical acne medications at the same time or immediately following the 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 doctor. Stop use and ask a doctor if irritation persists. 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. If contact occurs, rinse eyes thoroughly with water. using other topical acne medications at the same time or immediately following the 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 doctor." ], "questions": [ "Questions? 1-800-285-5170 www.olay.com" ], "spl_product_data_elements": [ "Olay Total Effects Cleanser Plus Blemish Control Salicylic Acid Salicylic Acid Salicylic Acid WATER GLYCERIN STEARYL ALCOHOL CETYL BETAINE DISTEARYLDIMONIUM CHLORIDE SODIUM LAURYL SULFATE CETYL ALCOHOL STEARETH-21 DOCOSANOL STEARETH-2 EDETATE DISODIUM" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Wet face Dispense product into hands Gently massage over skin Rinse thoroughly For best results use 1-3 times daily" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if irritation persists." ], "do_not_use": [ "For external use only." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 150 mL Tube Label OLAY ® total effects® 7-IN-1 ANTI-AGING SALICYLIC ACID ACNE CLEANSER cream cleanser plus blemish control 7 anti-aging benefits in 1 daily cream cleanser + salicylic acid for visibly younger and clearer-looking skin 5.0 FL OZ (150 mL) Principal Display Panel - 150 mL Tube Label" ], "indications_and_usage": [ "Uses for the treatment of acne" ], "set_id": "0ab73d52-dd01-401e-abdd-9bf02353e59e", "id": "32df0be8-c72f-4c82-9f81-9fac63cc08a6", "active_ingredient": [ "Active ingredient SALICYLIC ACID 2%" ] }, { "effective_time": "20130801", "inactive_ingredient": [ "INACTIVE INGREDIENT colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate." ], "purpose": [ "OTC - PURPOSE Pain reliever" ], "keep_out_of_reach_of_children": [ "OTC - 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 facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE 2208 (100 MPA.S) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE TALC CROSCARMELLOSE SODIUM PROPYLENE GLYCOL SODIUM BICARBONATE SODIUM LAURYL SULFATE TRIACETIN TRIETHYL CITRATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SP;03" ], "ask_doctor": [ "OTC - ASK A DOCTOR BEFORE USE IF stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor" ], "pregnancy_or_breast_feeding": [ "OTC - 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": [ "OTC - STOP USE AND ASK A DOCTOR IF you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs. Seek medical help right away. pain gets worse or lasts more than 10 days redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 15°-30°C (59°-86°F) do not use if seal on the carton is missing or damaged" ], "do_not_use": [ "OTC - DO NOT USE If you are allergic to aspirin or any other pain reliever/fever reducer." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 4a9520e4-figure-01" ], "indications_and_usage": [ "INDICATIONS AND USAGE for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief." ], "set_id": "0acef886-9e67-463f-9901-cb43a6650ecd", "id": "4a9520e4-2015-4055-a4e2-ec077a8b5f30", "ask_doctor_or_pharmacist": [ "OTC - ASK A DOCTOR/PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug for: Gout Diabetes arthritis" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20091203", "inactive_ingredient": [ "Inactive ingredients Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide DEA, Fragrance (Parfum), DMDM Hydantoin, Citric acid, Disodium EDTA, D and C Red No. 33, FD and C Blue No. 1" ], "warnings": [ "Warnings For external use only When using this product ， avoid contact with eyes. In case of contact, flush with water Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away" ], "when_using": [ "Directions Wet hands. Apply small amount to hands. Scrub thoroughly. Rinse. For children under 6, use only under adult supervision" ], "spl_product_data_elements": [ "Pier 1 Imports Sweet Grape Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE 1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN ANHYDROUS CITRIC ACID EDETATE DISODIUM D&C RED NO. 33 FD&C BLUE NO. 1 Coconut Breeze" ], "description": [ "Uses For hand washing to decrease bacteria on skin" ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "label label" ], "set_id": "0b0dfa42-a7b9-4acc-8dc6-b893cb5f3010", "id": "87358109-1e2b-4ab7-acb6-0d5ccde111f7", "active_ingredient": [ "Active ingredients Purpose Triclosan 0.115% Antibacterial" ] }, { "effective_time": "20111102", "inactive_ingredient": [ "Inactive Ingredients: Calcium Carbonate, Water, Sorbitol, Sodium Lauryl Sulfate, Silica, Carboxymethyl Cellulose, Flavor, Potassium Nitrate, Sodium benzoate, Sodium saccharin, menthol" ], "purpose": [ "Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "If more than is used for brushing is accidentally swallowed, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "MEDICHOICE ANTICAVITY FLUORIDE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SODIUM LAURYL SULFATE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE POTASSIUM NITRATE SODIUM BENZOATE SACCHARIN SODIUM MENTHOL" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions: Adults and children 2 yrs and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 yrs: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician. If more than is used for brushing is accidentally swallowed, seek professional help or contact a Poison Control Center immediately. Keep out of reach of children." ], "spl_unclassified_section": [ "Expiration Date: Expiration Date and Batch No. on crimp of Tube", "E.c No.: DD/COS/DD/C/52 Made in India MediChoice Reorder: 2002PC7385 Distributed by: Owens and Minor Mechanicsville, VA 23116 804.723.7000" ], "package_label_principal_display_panel": [ "tube", "MEDICHOICE Reorder: 2002PC7385 Anticavity Fluoride Toothpast 0.85 oz Contents: 144/bx Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "box", "Medichoice Reorder: 2002PC7385 Anticavity Fluoride Toothpaste 0.85 oz Contents: 144/bx, 5 boxes/cs, 720 cs Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "case" ], "indications_and_usage": [ "Use: Aids in the prevention of dental cavities." ], "set_id": "0b5a2788-ae38-44ca-bfc8-fb3c74ea95c9", "id": "fd3f54a2-301d-4b04-ae8c-13dc9b212848", "active_ingredient": [ "DRUG FACTS Active Ingredient: Purpose Sodium Fluoride 0.22% Anticavity Anticavity" ] }, { "spl_product_data_elements": [ "Colgate Sensitive Enamel Protect SODIUM FLUORIDE and POTASSIUM NITRATE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION HYDRATED SILICA WATER SORBITOL GLYCERIN POLYETHYLENE GLYCOL 600 SODIUM PYROPHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM XANTHAN GUM TITANIUM DIOXIDE" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022" ], "active_ingredient": [ "Active ingredients Purpose Potassium nitrate 5% Antisensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion) Anticavity" ], "active_ingredient_table": [ "
Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)Anticavity
" ], "purpose": [ "Active ingredients Purpose Potassium nitrate 5% Antisensitivity Sodium fluoride 0.24% (0.15% w/v fluoride ion) Anticavity" ], "purpose_table": [ "
Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)Anticavity
" ], "indications_and_usage": [ "Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact helps protect against cavities" ], "warnings": [ "Warnings When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist." ], "stop_use": [ "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 yearsconsult a dentist or physician
" ], "inactive_ingredient": [ "Inactive ingredients water, sorbitol, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin, xanthan gum, titanium dioxide" ], "questions": [ "Questions or comments? Call toll-free 1-800-468-6502" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 113 g Tube Carton Colgate ® Toothpaste for Sensitive Teeth and Cavity Protection MAXIMUM STRENGTH* Sensitive enamelprotect Clinically Proven Sensitivity Relief NET WT 4.0 OZ (113 g) ✔ Helps Protect Against Acid Wear ✔ Hardens Enamel Principal Display Panel - 113 g Tube Carton" ], "set_id": "0bbe502e-b75f-43a9-af00-df14c849e079", "id": "e3c89f7d-c0cf-4b7b-9761-87378444a9db", "effective_time": "20130726", "version": "3", "openfda": {} }, { "effective_time": "20140221", "inactive_ingredient": [ "Inactive ingredients (Advanced Acne Treatment) benzyl alcohol, ceteareth-20, citric acid, disodium EDTA, purified water, sodium citrate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).", "Inactive Ingredients (Deep Cleanser) citric acid, disodium EDTA, purified water, sodium citrate, sodium lauryl sulfate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).", "Inactive Ingredients (Foaming Wash) cetearyl alcohol, cocamidopropyl betaine, glycerin, glycolic acid, hydrogenated castor oil, lactic acid, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, and titanium dioxide, zea mays (corn) starch.", "Inactive Ingredients (Spot Treatment) ceteareth-20, cetylalcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol" ], "purpose": [ "Purpose Acne medication" ], "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. (AAT, DC, FW)" ], "warnings": [ "Warnings For external use only Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide. Stop use and ask a doctor if • irritation becomes severe. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (AAT, DC, FW)" ], "questions": [ "Questions? call 1-888-784-3335 (1-888-STIEFEL). Side effects may be reported to the number." ], "spl_product_data_elements": [ "MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE BENZYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER SODIUM CITRATE XANTHAN GUM MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER SODIUM CITRATE SODIUM LAURYL SULFATE XANTHAN GUM MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL COCAMIDOPROPYL BETAINE GLYCERIN GLYCOLIC ACID HYDROGENATED CASTOR OIL LACTIC ACID MINERAL OIL POLYETHYLENE GLYCOL 600000 POTASSIUM PHOSPHATE, UNSPECIFIED FORM WATER SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM PYRROLIDONE CARBOXYLATE TITANIUM DIOXIDE STARCH, CORN MaxClarity benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE POLYOXYL 20 CETOSTEARYL ETHER CETYL ALCOHOL DIMETHYL ISOSORBIDE WATER DIMETHICONE SILICON DIOXIDE STEARYL ALCOHOL" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions (Advanced Acne Treatment) • Clean the area thoroughly before applying this product. • Shake can before use. • Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball). • Using fingers, cover the entire affected area with a thin layer 1 to 3 times daily. • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.", "Directions (Deep Cleanser) • Wet area to be cleaned. • Shake can before use. • Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball). • Apply and gently massage area for 1 to 2 minutes. • Rinse thoroughly and pat dry. • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.", "Directions (Foaming Wash) • Wet area to be cleansed. • Apply acne wash and gently massage area for 1 to 2 minutes. Rinse thoroughly and pat dry. • Because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily, if needed or as directed by a doctor. • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.", "Directions (Spot Treatment) Clean 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 doctor. If going outside, apply sunscreen after using this product. Allow MaxClarity Spot Treatment to dry, then follow directions in the sunscreen labeling if irritation or sensitivity develops, stop use of both products and ask a doctor." ], "stop_use": [ "Stop use and ask a doctor if • irritation becomes severe." ], "storage_and_handling": [ "Other information (Advanced Acne Treatment, Deep Cleanser) Store at 68° to 77°F (20° to 25°C). Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).", "Other information (Foaming Wash) Store at controlled room temperature 59° - 86°F (15° - 30°C).", "Other information (Spot Treatment) Store at room temperature." ], "do_not_use": [ "Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0145-2842-02 MaxClarity™ foam acne medication Advanced Acne Treatment with VersaFoam® Technology Benzoyl Peroxide 2.5% Net Wt 2.64 Oz (75 g) MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories www.maxclarity.com To reorder call 877-LIKE-MAX Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION CFC FREE 10000000093323 MaxClarity Advanced Acne Treatment label", "Principal Display Panel NDC 0145-2840-02 MaxClarity™ foam acne medication Deep Cleanser with VersaFoam® Technology Benzoyl Peroxide 2.5% Net Wt 2.64 Oz (75 g) MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. www.maxclarity.com To reorder call 877-LIKE-MAX Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION CFC FREE 10000000093321 MaxClarity Deep Cleanser label", "Principal Display Panel NDC 0145-2832-09 MaxClarityTM Foaming Wash Acne Medication Benzoyl Peroxide 2.5% Steiefel Net Wt. 5.5 Oz (156 g) Stiefel Laboratories, Inc. RTP, NC 27709 Rev. 1/12 MAXCLARITY is a trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. www.maxclarity.com A102555 MaxClarity Foaming Wash Label", "Principal Display Panel NDC 0145-2847-10 MaxClarity™ Spot Treatment Acne Medication Benzoyl Peroxide 8% Net Wt. .35 Oz (10g) Stiefel Laboratories, Inc. RTP, NC 27709 2012 Stiefel Laboratories, Inc. Made in Canada Rev2/12 A102591 MaxClarity Spot Treatment Label" ], "indications_and_usage": [ "Use For the treatment of acne" ], "set_id": "0bdf0a5d-51ea-4136-a16d-1c115bc7877d", "id": "edd1b73a-f40e-4bcf-afbd-45f2ab25eb38", "active_ingredient": [ "Active ingredient (Advanced Acne Treatment, Deep Cleanser, Foaming Wash) Benzoyl peroxide 2.5%", "Active Ingredient (Spot Treatment) Benzoyl peroxide 8%" ] }, { "effective_time": "20130221", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol" ], "purpose": [ "Purpose Anti-itch cream" ], "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 eyes by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor. 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 consult a doctor before exceeding recommended dosage" ], "questions": [ "Questions? Call 1-866-923-4914" ], "spl_product_data_elements": [ "Hydrocortisone with Aloe Hydrocortisone Hydrocortisone Hydrocortisone cetostearyl alcohol sodium lauryl sulfate sodium cetostearyl sulfate citric acid monohydrate glycerin glyceryl monostearate methylparaben mineral oil paraffin propylparaben water stearyl alcohol" ], "ask_doctor": [ "Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions 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: do not use. consult a doctor For external anal itching: Adults: when practical, cleanse 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 application of this product Children under 12 years of age: consult a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544" ], "stop_use": [ "Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor." ], "storage_and_handling": [ "Other information To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube store at room temperature see carton or tube crimp for lot number and expiration date" ], "do_not_use": [ "Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 60 g Tube Carton meijer ™ Compare to Cortizone•10 ® active ingredient* Maximum Strength With Aloe Anti-Itch Relief 1% Hydrocortisone Cream Antipruritic NET WT 2 0Z (60 g) Principal Display Panel - 60 g Tube Carton" ], "indications_and_usage": [ "Uses temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy, poison oak, or poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external genital and anal itching other uses of this product should be only under the advice and supervision of a doctor" ], "set_id": "0ccbc9a6-a705-4604-b9d4-078f0dc36a03", "id": "4cfb507c-dc92-4282-9931-fd9c57510d1a", "active_ingredient": [ "Active ingredient Hydrocortisone 1%" ] }, { "effective_time": "20151118", "inactive_ingredient": [ "OTHER INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5." ], "purpose": [ "Topical Anesthetic External Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, consult physician." ], "warnings": [ "WARNINGS: For external use only. Avoid contact with eyes. Do not apply on open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. Do not bandage tightly. If pregnant or breast-feeding, contact physician prior to use. Do not use in large quantities, particularly over raw surfaces or blistered areas. Keep out of reach of children. If swallowed, consult physician." ], "spl_product_data_elements": [ "BenePatch LIDOCAINE HYDROCHLORIDE, MENTHOL FD&C BLUE NO. 1 GREEN TEA LEAF GLYCERIN PEG-8 STEARATE ISOPROPYL MYRISTATE PHENOXYETHANOL ALOE VERA LEAF POLYSORBATE 80 SODIUM LAURYL SULFATE TROLAMINE ARNICA MONTANA INDIAN FRANKINCENSE FD&C YELLOW NO. 5 ETHYLHEXYLGLYCERIN CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) WATER MENTHOL MENTHOL LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS patch" ], "openfda": {}, "version": "11", "dosage_and_administration": [ "DIRECTIONS: Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches/day. Leave patch on affected area for up to 8 hours. Do not use patches for longer than 5 consecutive days. Children under 12 should consult physician prior to use." ], "package_label_principal_display_panel": [ "Package Labeling for BenePatch, 15 Count (69418-002-01) Front Back" ], "indications_and_usage": [ "USES: For temporary relieft of pain associated with minor cuts, scrapes and minor skin irritations." ], "set_id": "0ce3c764-b905-418a-e054-00144ff8d46c", "id": "24d86c23-664b-00dc-e054-00144ff8d46c", "active_ingredient": [ "ACTIVE INGREDIENTS: Lidocaine HCL 4.00% Menthol 1.00%" ] }, { "effective_time": "20120529", "inactive_ingredient": [ "INACTIVE INGREDIENTS: WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, FRAGRANCE (PARFUM), CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, SODIUM XYLENESULFONATE." ], "purpose": [ "PURPOSE ANTIDANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER." ], "questions": [ "QUESTIONS OR COMMENTS? 1-888-723-3929" ], "spl_product_data_elements": [ "SAFEWAY DANDRUFF DRY SCALP PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE DIMETHICONE CETYL ALCOHOL POLYQUATERNIUM-10 (400 CPS AT 2%) MAGNESIUM SULFATE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE AMMONIUM LAURETH-3 SULFATE BENZYL ALCOHOL SODIUM CHLORIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM XYLENESULFONATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED." ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED." ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF." ], "set_id": "0d2241dd-79a6-48cb-9e8e-b28a23b38139", "id": "db7d8507-aa48-4ba5-b14a-a907b07c71bc", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTIDANDRUFF" ] }, { "effective_time": "20140102", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTIDANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "EQUALINE CLASSIC CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USING THIS PRODUCT AND ASK DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "0d6ea23f-5860-4a4a-a318-bf4944ea8531", "id": "26c313b9-fd6b-4e2f-96f7-70a2707faf89", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTIDANDRUFF" ] }, { "effective_time": "20130815", "inactive_ingredient": [ "Inactive ingredients water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben", "Inactive ingredients water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT", "Inactive ingredients 1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.", "Warnings Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.", "Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time" ], "spl_product_data_elements": [ "NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM PPG-2 MYRISTYL ETHER PROPIONATE TROLAMINE SALICYLATE SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYL TRIMETHICONE NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE AND ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE CYCLOMETHICONE 5 WATER GLYCERIN PHENOXYETHANOL XANTHAN GUM CHLORPHENESIN PENTYLENE GLYCOL PHENYL TRIMETHICONE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SQUALANE POLYSORBATE 60 PEG-40 STEARATE DIMETHICONE STEARYL ALCOHOL CETOSTEARYL ALCOHOL SODIUM DIHYDROXYCETYL PHOSPHATE HYDROGENATED PALM GLYCERIDES POLYOXYL 20 CETOSTEARYL ETHER CITRIC ACID MONOHYDRATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL TROPOLONE EDETATE DISODIUM POTASSIUM SORBATE SODIUM BENZOATE METHYLISOTHIAZOLINONE TETRAHEXYLDECYL ASCORBATE SODIUM POLYACRYLATE (2500000 MW) NU-DERM GENTLE CLEANSER inert WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE ALOE VERA LEAF GLYCERETH-7 PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE SAGE FD&C YELLOW NO. 5 APRICOT KERNEL OIL NU-DERM TONER inert WATER GLYCERIN HAMAMELIS VIRGINIANA TOP WATER SODIUM PYRROLIDONE CARBOXYLATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE POTASSIUM ALUM PANTHENOL SAGE CALENDULA OFFICINALIS FLOWER POLYSORBATE 80 ALLANTOIN ALOE VERA LEAF FD&C BLUE NO. 1 NU-DERM EXFODERM inert WATER GLYCERIN DIETHYLENE GLYCOL MONOETHYL ETHER METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL STEARETH-20 CANOLA OIL ISOHEXADECANE MAGNESIUM ALUMINUM SILICATE CETYL ALCOHOL FYTIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHICONE PEG-150 STEARATE PHENOXYETHANOL BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN POTASSIUM CETYL PHOSPHATE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE GLYCERETH-7 NU-DERM HYDRATE FACIAL MOISTURIZER inert WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE CAESALPINIA SPINOSA RESIN SHEA BUTTER GLYCERYL MONOSTEARATE CYCLOMETHICONE 5 CETYL ALCOHOL SACCHARIDE ISOMERATE DIMETHICONE TOCOPHEROL LAURETH-12 PHENOXYETHANOL ETHYLHEXYLGLYCERIN STEARIC ACID AVOCADO OIL SOY STEROL CAPRYLYL GLYCOL LEVOMENOL HEXYLENE GLYCOL TETRAHYDRODIFERULOYLMETHANE PANTHENOL MANGIFERA INDICA SEED BUTTER SODIUM STEAROYL GLUTAMATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALLANTOIN" ], "description": [ "Each gram of Obagi Nu-Derm Clear contains: Active ingredient Hydroquinone USP, 4% (40 mg/g) Inactive ingredients water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben", "Each gram of Obagi Nu-Derm Blender contains: Active ingredient Hydroquinone USP, 4% (40 mg/g) Inactive ingredients water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and administration Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.", "Dosage and administration Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.", "Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "spl_unclassified_section": [ "Clear (Skin Bleaching and Corrector Cream) NDC 62032-101-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only AM+PM Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.", "See enclosed Package Insert for full prescribing information. Rx ONLY. FOR EXTERNAL USE ONLY.", "Blender ® (Skin Lightener and Blending Cream) NDC 62032-100-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only PM A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. or Refissa ® Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. as prescribed by a physician.", "See enclosed Package Insert for full prescribing information. Rx ONLY. FOR EXTERNAL USE ONLY.", "Travel Bag and Patient Instruction Guide", "Obagi Hydrate is a trademark, and Blender, Exfoderm, Nu-Derm, and the Obagi logo are registered trademarks, of OMP, Inc. Refissa is a registered trademark of Spear Pharmaceuticals, Inc. Distributed by OMP, Inc., Long Beach, CA 90806 ©2012 Obagi Medical Products, Inc. All rights reserved. obagi.com Made in USA 41706111Z 7061", "Sun Shield Broad Spectrum SPF 50 Matte Net wt. 3 oz. (85 g) This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.", "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Store at controlled room temperature 15°C–25°C (59°F–77°F).", "Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-520-00 OBAGI ® MEDICAL NU-DERM ® SYSTEM NORMAL DRY Skin Transformation Kit PRINCIPAL DISPLAY PANEL - Kit Carton" ], "indications_and_usage": [ "Indications and usage The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.", "Indications and usage The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.", "Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0d91be8e-1553-4ef7-b333-724c0e27651e", "id": "1be2dfad-d98e-4b0d-9d07-4820deb8e2aa", "active_ingredient": [ "Active ingredients Octinoxate 7.5% Zinc Oxide 10.5%" ] }, { "effective_time": "20120531", "inactive_ingredient": [ "Inactive ingredients Water, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Propylene Glycol, Sodium Chloride, DMDM Hydantoin, Glycerine, Tetrasodium EDTA, Fragrance, Methylchloroisothiazolinone, (and) Methyisothiazolinone, FDandC Yellow No.5, FDandC Red No.4" ], "purpose": [ "Purpose Antimicrobial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately." ], "warnings": [ "Warnings For external use only When using this product do not use in or near eyes. Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately." ], "when_using": [ "When using this product do not use in or near eyes." ], "spl_product_data_elements": [ "Pro pride Antibacterial Hand Chloroxylenol Chloroxylenol Chloroxylenol WATER SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE PROPYLENE GLYCOL SODIUM CHLORIDE DMDM HYDANTOIN GLYCERIN EDETATE SODIUM METHYLCHLOROISOTHIAZOLINONE FD&C YELLOW NO. 5 FD&C RED NO. 4" ], "other_safety_information": [ "Other information Store at room temperature" ], "openfda": {}, "version": "22984", "dosage_and_administration": [ "Directions Wet hands, dispense a small amount of soap into the palm of the hand, work up a lather, adding water as needed, rinse." ], "package_label_principal_display_panel": [ "image of front label image of back label" ], "indications_and_usage": [ "Uses Antimicrobial Hand Soap" ], "set_id": "0dd20d84-8c5b-47dd-be4e-a35e3988805d", "id": "8f6e267c-a316-4bae-9f81-346def997ef7", "active_ingredient": [ "Active ingredient Chloroxylenol - 0.3%" ] }, { "effective_time": "20110919", "purpose": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% 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." ], "when_using": [ "When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptions. Contains a sunscreen to help prevent darkening from reoccurring." ], "set_id": "0de38654-f598-4cca-9e1e-47af1f21d21c", "id": "7d2ff072-8745-4a24-9ee4-6caf23fa9ad2", "active_ingredient": [ "Active ingredients: Purpose: Hydroquinone USP 2% Skin Lightener Oxybenzone USP 2.5% Sunscreen Padimate O USP 3.3% Sunscreen" ], "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl monostearate, isopropyl palmitate NF, ozokerite wax, mineral oil light NF, stearyl alcohol NF, PEG 1500 monostearate, poloxamer 188, propylene glycol USP, steareth-20, laureth-23, allantoin ascorbate, sodium bisulfite NF, steareth-10, dimethicone, sodium lauryl sulfate NF, methylparaben NF, fragrance, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "warnings": [ "Warnings For external use only. Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away." ], "spl_product_data_elements": [ "Esoterica Daytime with Sunscreen hydroquinone, oxybenzone, and padimate o hydroquinone hydroquinone oxybenzone oxybenzone padimate o padimate o water glyceryl monostearate isopropyl palmitate ceresin mineral oil stearyl alcohol polyethylene glycol 1500 poloxamer 188 propylene glycol steareth-20 laureth-23 allantoin sodium bisulfite steareth-10 dimethicone sodium lauryl sulfate methylparaben propylparaben edetate disodium butylated hydroxyanisole" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "do_not_use": [ "Do not use • On inflamed or broken skin • For prevention of sunburn • As sunscreen • On children under 12 years of age unless directed by a physician" ], "active_ingredient_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70g Carton Skin Lightener with Sunscreen NDC # 99207-292-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM DAYTIME With Sunscreen Net Wt. 2.5 oz (70g) Principal Display Panel - 70g Carton" ], "purpose_table": [ "
Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen
" ] }, { "effective_time": "20120926", "inactive_ingredient": [ "INACTIVE INGREDIENTS Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have Liver disease. Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin. Stop use and ask a doctor if the tablet got stuck in your throat pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more then the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE Capsule shaped cor116" ], "ask_doctor": [ "Ask a doctor before use if you have Liver disease." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if the tablet got stuck in your throat pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Lasts up to 8 Hours Use only as directed. NDC 21130-760-51 Arthritis Pain Relief Compare to Tylenol ® Arthritis Pain active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For The Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ™ DISTRIBUTED BY SAFEWAY INC. 5089374/R1011 This is the 100 count bottle carton label for Safeway APAP Arthritis." ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "0eb865a6-229e-452d-a6a9-eb213018d192", "id": "0a02ebb4-0d21-4159-b143-54662c512451", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
children under 18 years of age ask a doctor
" ] }, { "effective_time": "20110301", "inactive_ingredient": [ "Inactive Ingredient Section: water , sodium lauryl sulfate, Cocamide DEA, cocamidopropyl Betaine, Sodium Chloride, Disodium EDTA, Citric Acid, Fragrance, Methylchloroisothiazolinone and Methylisothiazolinone" ], "purpose": [ "uses Uses: For hand washing and to decrease bacterial on the skin. Recommended for repeated use." ], "keep_out_of_reach_of_children": [ "keep out of reach of children . In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately." ], "warnings": [ "warning: For external use only. When using this product, keep out of eyes. In case of contact with eyes, immediately flush eyes with water. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor." ], "spl_product_data_elements": [ "black hawks TRICLOSAN water sodium lauryl sulfate COCO DIETHANOLAMIDE Cocamidopropyl Betaine sodium chloride edetate disodium citric acid methylchloroisothiazolinone methylisothiazolinone TRICLOSAN TRICLOSAN green apple flavor" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use. For external use only. When using this product, keep out of eyes. In case of contact with eyes, immediately flush eyes with water. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor." ], "package_label_principal_display_panel": [ "image of apple" ], "indications_and_usage": [ "Direction : Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use." ], "set_id": "0f0f89c2-81e0-4296-b295-e3986cd6dc2b", "id": "81df65c1-bc2e-477a-b4ea-9e11518c7f8c", "active_ingredient": [ "Active Ingredients-------------------purpose Triclosan 0.2%-----------------------antibacterial" ] }, { "effective_time": "20131203", "inactive_ingredient": [ "Inactive ingredients Water, sodium laureth sulfate, sodium lauryl sulfate, glycol distearate, dimethicone, cocamidopropyl betaine, sodium citrate, cocamide mea, sodium xylenesulfonate, fragrance, citric acid, sodium benzoate, guar hydroxypropyltrimonium chloride, benzyl alcohol, sodium chloride, panthenol, panthenyl ethyl ether, methylisothiazolinone." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions [or comments]? 1-800-945-7768" ], "spl_product_data_elements": [ "Pantene Pro-V Anti-dandruff pyrithione zinc pyrithione zinc pyrithione zinc water sodium laureth-3 sulfate sodium lauryl sulfate glycol distearate dimethicone cocamidopropyl betaine sodium citrate coco monoethanolamide sodium xylenesulfonate citric acid monohydrate sodium benzoate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) benzyl alcohol sodium chloride panthenol methylisothiazolinone Pantene Pro-V Anti-dandruff 2in1 pyrithione zinc pyrithione zinc pyrithione zinc water sodium laureth-3 sulfate sodium lauryl sulfate dimethicone glycol distearate cocamidopropyl betaine sodium citrate coco monoethanolamide sodium xylenesulfonate citric acid monohydrate sodium benzoate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) benzyl alcohol sodium chloride panthenol methylisothiazolinone" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wet hair, massage into hair and scalp to create lather. Rinse. for best results use at least twice a week or as directed by a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 675 mL Bottle Label FIGHTS FLAKES, ITCHING, AND IRRITATION PANTENE PRO-V Pyrithione Zinc Anti-Dandruff Shampoo ALL HAIR TYPES Anti-Dandruff SHAMPOO 92082231 22.8 FL OZ (675 mL) Principal Display Panel - 675 mL Bottle Label", "PRINCIPAL DISPLAY PANEL - 675 mL Bottle Label FIGHTS FLAKES, ITCHING, AND IRRITATION PANTENE PRO-V Pyrithione Zinc Anti-Dandruff Shampoo & Conditioner ALL HAIR TYPES 2 IN 1 Anti-Dandruff SHAMPOO & CONDITIONER 92082224 22.8 FL OZ (675 mL) Principal Display Panel - 675 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "0fcdbb02-44fa-4702-af51-de7b52b77578", "id": "ffe0adf8-e3a0-4478-b577-23eb02ceb4fa", "active_ingredient": [ "Active ingredient Pyrithione zinc 0.5%" ] }, { "effective_time": "20100713", "inactive_ingredient": [ "Inactive Ingredients purified water, alcohol denat., PEG-8, propylene glycol, sodium lauryl sulfate, fragrance, citric acid, menthol, disodium EDTA." ], "purpose": [ "Use - for the treatment of acne" ], "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 until dry, keep away from extreme heat or open flame. When using this product - with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation may occur. If this occurs, only one acne medication should be used unless directed by a doctor - avoid contact with eyes Stop use and ask a doctor if skin irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "CVS Daily Pore Clearing Pads SALICYLIC ACID WATER DOCUSATE SODIUM CARBOMER HOMOPOLYMER TYPE C SODIUM HYDROXIDE EDETATE SODIUM SALICYLIC ACID SALICYLIC ACID" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - cleanse face and rinse thoroughly before applying medication - wipe pad over face and neck covering the affected area - 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. - use daily for best results Other Information - store in a cool dry place - close jar tightly" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Directions - cleanse face and rinse thoroughly before applying medication - wipe pad over face and neck covering the affected area - 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. - use daily for best results Other Information - store in a cool dry place - close jar tightly" ], "set_id": "0fde16f4-030c-4243-8e23-ebfa6fdc90d0", "id": "3032b9b8-012e-4148-be34-a0e52d4809db", "active_ingredient": [ "Active ingredient Purpose Salicylic Acid, 2%.......................................Acne medication" ] }, { "effective_time": "20130320", "inactive_ingredient": [ "Inactive Ingredients Inactive ingredients acrylates copolymer, benzyl alcohol, cetyl alcohol, cocamide MEA, dimethicone, FDC blue no.1, fragrance, glycol distearate, methylchloroisothiazolinone, methylisothiazolinone, polyquaterinum-10, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine, water, zinc sulfate" ], "purpose": [ "Purpose Anti-Dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children If swallowed get medical help or contact a Poison Control Center right away." ], "warnings": [ "W arnings For external use only" ], "when_using": [ "When using this product •avoid contact with eyes • if contact occurs, rinse eyes with plenty of water." ], "spl_product_data_elements": [ "BEING WELL BODY 2in1 Dandruff and Conditioner pyrithione zinc PYRITHIONE ZINC PYRITHIONE ZINC BENZYL ALCOHOL CETYL ALCOHOL COCO MONOETHANOLAMIDE DIMETHICONE FD&C BLUE NO. 1 GLYCOL DISTEARATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE POLYQUATERNIUM-10 (400 CPS AT 2%) SODIUM CHLORIDE SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE TROLAMINE WATER ZINC SULFATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions •wet hair •lather •massage onto scalp •rinse well •repeat if desired •for best results use regularly" ], "stop_use": [ "Stop use and ask a doctor if condition does not improve or worsen after regular use of this product as directed" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Uses • helps eliminate irritation and flaking associated with dandruff." ], "set_id": "0fe3ea18-845a-4847-90e7-0e918a85307b", "id": "5ac4701d-89dd-4bc8-85a8-66d66ed8b146", "active_ingredient": [ "Active Ingredient Pyrithione Zinc 1%" ] }, { "effective_time": "20140627", "inactive_ingredient": [ "Inactive ingredients Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions (or comments)? 1-800-723-9569" ], "spl_product_data_elements": [ "Head and Shoulders 2in1 Green Apple Pyrithione Zinc Pyrithione Zinc Pyrithione Zinc water sodium lauryl sulfate sodium laureth-3 sulfate glycol distearate zinc carbonate sodium chloride sodium xylenesulfonate dimethicone cocamidopropyl betaine sodium benzoate magnesium carbonate hydroxide methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 fd&c yellow no. 5" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp, rinse, repeat if desired." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo + conditioner IMPROVES HAIR & SCALP HEALTH GUARANTEED 2 in 1 green apple for a clean fresh scent 14.2 FL OZ (420 mL) 99860229 Principal Display Panel - 420 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "100eb534-7525-4cd0-aa7e-406885faa8fd", "id": "96d04ec7-8a30-4518-aa78-802afebf9580", "active_ingredient": [ "Active ingredient Pyrithione zinc 1%" ] }, { "effective_time": "20150302", "drug_interactions": [ "Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established." ], "precautions": [ "PRECAUTIONS General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis). Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal ).", "Perioperative Use Administration of clonidine hydrochloride tablets, USP should be continued to within four hours of surgery and resumed as soon as possible thereafter. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required." ], "description": [ "DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure", "Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. Structure" ], "general_precautions": [ "General In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to clonidine transdermal system, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected." ], "storage_and_handling": [ "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "pharmacokinetics": [ "Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "indications_and_usage": [ "INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents." ], "set_id": "104a3cba-6ed9-48b3-e054-00144ff8d46c", "id": "104fea5c-cb2d-16c3-e054-00144ff88e88", "teratogenic_effects": [ "Teratogenic Effects:", "Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal )." ], "inactive_ingredient": [ "The inactive ingredients are dibasic calcium phosphate, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate. The clonidine hydrochloride 0.1 mg tablet also contains FD&C Blue #1 aluminum lake and FD&C Red #40 aluminum lake." ], "contraindications": [ "CONTRAINDICATIONS Clonidine hydrochloride tablets, USP should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS )." ], "warnings": [ "WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.", "Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication." ], "pregnancy": [ "Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets, USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as ⅓ the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed." ], "nursing_mothers": [ "Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman." ], "spl_product_data_elements": [ "Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO FD&C BLUE NO. 1 FD&C RED NO. 40 CLONIDINE HYDROCHLORIDE CLONIDINE light tan 25;41;V Clonidine Hydrochloride clonidine hydrochloride CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO CLONIDINE HYDROCHLORIDE CLONIDINE 25;42;V" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.", "Adults The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.", "Initial Dose 0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.", "Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.", "Renal Impairment Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis." ], "animal_pharmacology_and_or_toxicology": [ "Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged. In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days." ], "adverse_reactions": [ "ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol. Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria. Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes." ], "spl_unclassified_section": [ "Rx only Oral Antihypertensive Tablets of 0.1, 0.2 and 0.3 mg Prescribing Information", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181999 R6/12-R6" ], "how_supplied": [ "HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are available as: 0.1 mg: light tan, oval, scored, convex, debossed \"25\" bisect \"41\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2957-10 Bottles of 90: NDC 0603-2957-02 Bottles of 100: NDC 0603-2957-21 Bottles of 180: NDC 0603-2957-04 Bottles of 500: NDC 0603-2957-28 Bottles of 1000: NDC 0603-2957-32 Bottles of 2500: NDC 0603-2957-30 0.2 mg: orange, oval, scored, convex, debossed \"25\" bisect \"42\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2958-10 Bottles of 100: NDC 0603-2958-21 Bottles of 500: NDC 0603-2958-28 Bottles of 1000: NDC 0603-2958-32 Bottles of 2500: NDC 0603-2958-30 0.3 mg: peach, oval, scored, convex, debossed \"25\" bisect \"43\" on one side and debossed \"V\" on the reverse side, supplied as follows: Bottles of 10: NDC 0603-2959-10 Bottles of 100: NDC 0603-2959-21 Bottles of 500: NDC 0603-2959-28 Bottles of 1000: NDC 0603-2959-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container." ], "information_for_patients": [ "Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes." ], "package_label_principal_display_panel": [ "Principal Display Panel Clonidine Hydrochloride Tablets, USP 0.1mg 90 Tablets NDC 10544-196-90 Label", "PrincipalDisplay Panel Clonidine Hydrochloride Tablets, USP 0.2mg 90 Tablets NDC 10544-199-90 Label" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly. The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent. Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45° tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long-term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise. Tolerance to the antihypertensive effect may develop in some patients, necessitating a re-evaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated. Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m 2 basis)." ], "overdosage": [ "OVERDOSAGE Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children. There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine. The largest overdose reported to date involved a 28-year-old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD 50 of clonidine is 206 and 465 mg/kg, respectively." ] }, { "spl_product_data_elements": [ "Colgate Junior Fresh Protect SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM LAURYL SULFATE SACCHARIN SODIUM MICA TITANIUM DIOXIDE FD&C BLUE NO. 1" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022" ], "active_ingredient": [ "Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)" ], "purpose": [ "Purpose Anticavity" ], "indications_and_usage": [ "Use helps protect against cavities" ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician" ], "dosage_and_administration_table": [ "
adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician
" ], "inactive_ingredient": [ "Inactive ingredients sorbitol, water, hydrated silica, PEG-12, cellulose gum, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1" ], "questions": [ "Questions? 1-800-468-6502" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 g Tube Carton Colgate ® Anticavity Fluoride Toothpaste FRESH 'N PROTECT ™ CLINICALLY PROVEN CAVITY AND ENAMEL PROTECTION mild mint flavor toothpaste ages 8 + FRESH 'N PROTECT ADA Accepted American Dental Association ® NET WT 0.85 OZ (24 g) Principal Display Panel - 24 g Tube Carton" ], "set_id": "1051a550-cfb5-48da-b937-8d282596b000", "id": "6b2d51da-7c02-4b00-83ef-e829bb819a3e", "effective_time": "20120124", "version": "2", "openfda": {} }, { "effective_time": "20130702", "inactive_ingredient": [ "Inactive ingredients lactose, magnesium silicate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, titanium dioxide and triacetin image of carton" ], "purpose": [ "Purpose Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not exceed recommended dosage" ], "spl_product_data_elements": [ "Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM LACTOSE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE MAGNESIUM SILICATE MAGNESIUM STEARATE RCCGPE;C27" ], "ask_doctor": [ "Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ excessive phlegm;mucus ■ difficulty in urination due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if ■ nervousness, dizziness or sleeplessness occurs ■ symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) ■ cough and congestion do not improve within 7 days or tend to recur. These could be signs of a serious condition ." ], "do_not_use": [ "Do not use ■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive" ], "set_id": "10874e99-e7fa-4994-9af8-7e203262b1cc", "id": "096b79d6-3275-42b2-99ba-fed836ade8dc", "active_ingredient": [ "Active ingredient - (per tablet) Guaifenesin 400 mg Phenylephrine HCl 10 mg" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-356-0783" ], "spl_product_data_elements": [ "Rapid Comfort Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 Rapid Comfort Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Label Safety Ibuprofen Label 60683-083 Lab Safety Ibuprofen Label 60683-083 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-083", "Lab Safety Ibuprofen Label 60683-082 Lab Safety Ibuprofen Label 60683-082 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-082" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "108f8ac2-7b89-422d-9bb2-d26c4e01e939", "id": "0c3b148b-f2b9-3a0e-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150308", "inactive_ingredient": [ "aloe barbadensis leaf, water, arnica montan extract, boswella serrata extract, camelia sinensis leaf extract, carbomer, ethylhexylglycerine, glycerine, isopropyl myristate, PEG 8, phenoxyethanol, polysorbate 80, sodium lauryl sulfate, triethanolamine, fd&c blue #1, fd&c yellow #5" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "purpose": [ "Topical anesthetic External analgesic" ], "spl_product_data_elements": [ "Releevia LM Patch Lidocaine Hydrochloride WATER GLYCERIN ARNICA MONTANA POLYSORBATE 80 ALOE VERA LEAF BOSWELLIA SACRA WHOLE GREEN TEA LEAF CARBOMER 1342 ETHYLHEXYLGLYCERIN ISOPROPYL MYRISTATE PEG-8 GLYCERYL ISOSTEARATE PHENOXYETHANOL SODIUM LAURYL SULFATE TRIETHANOLAMINE BENZOATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS MENTHOL MENTHOL" ], "warnings_and_cautions": [ "Warnings For external use only Avoid contact with eyes Do not applly to open wounds or damaged skin If symptoms persist for more than seven days, discontinue use and consult physician If swallowed, consult physician Do not bandage tightly If pregnant or breast feeding, contact physician prior to use Do not use in large quantities, particularly over raw surfaces or blistered areas" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "clean and dry affected area remove patch from backing and apply to affected area use only one patch at a time, and maximum of four patches/day leave patch on affected area for up to 8 hours do not use patches for longer than five consecutive days children under 12 should consult physician prior to use" ], "package_label_principal_display_panel": [ "Releevia LM Patch box image" ], "indications_and_usage": [ "Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations" ], "set_id": "10d1bcb7-c2f3-1145-e054-00144ff88e88", "id": "10d1bcb7-c2f4-1145-e054-00144ff88e88", "active_ingredient": [ "Lidocaine HCL 4.00% Menthol 1.00%" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings:" ], "when_using": [ "When using this product Avoid alcoholic drinks. Marked drowsiness may occur. Excitability may occur, especially in children. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery." ], "spl_product_data_elements": [ "Diphenhydramine HCL Diphenhydramine HCL FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PH014" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture" ], "do_not_use": [ "Do not use With any other product containing Diphenhydramine HCL, including one applied topically." ], "package_label_principal_display_panel": [ "Principal Display Panel Blenheim Pharmacal, Inc. NDC 10544-166-15 Diphenhydramine HCl Capsules, USP 25mg 15 Capsules 25mg 15ct" ], "indications_and_usage": [ "Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes." ], "set_id": "117fead9-699d-57ae-e054-00144ff88e88", "id": "11a88159-9fdc-1983-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you have: Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Glaucoma If you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
Adults and children 12 years or over 1 to 2 capsule
Children 6 to under 12 years 1 capsule
Children under 6 years ask a doctor
" ] }, { "effective_time": "20101130", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), water, glycerin, sodium saccharin, PEG-8, flavor, cellulose gum, sodium lauryl sulfate, sodium lauroyl sarcosinate" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Dental Care Advance Cleaning Maximun Strength Cleaning Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE WATER GLYCERIN SACCHARIN SODIUM DIHYDRATE POLYETHYLENE GLYCOL 400 CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste DENTAL CARE Advance Cleaning FRESH MINT MAXIMUM STRENGTH CLEANING NET WT. 4.5 OZ. (127g) FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "1272f906-768e-4255-a283-4fe408bd69e8", "id": "1547d13c-2dd0-4325-8e15-c87221cc4e45", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20110919", "inactive_ingredient": [ "Inactive ingredients purified water USP, glyceryl stearate, isopropyl palmitate NF, light mineral oil NF, ozokerite, propylene glycol USP, stearyl alcohol NF, PEG-1500 stearate, poloxamer 188, propylene glycol monostearate NF, steareth-20, laureth-23, sodium metabisulfite NF, sodium lauryl sulfate NF, anhydrous citric acid USP, fragrance, methylparaben NF, dimethicone, propylparaben NF, edetate disodium, butylated hydroxyanisole" ], "purpose": [ "Purpose Skin Lightener" ], "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 inflamed or broken skin • On children under 12 years of age unless directed by a physician Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid When using this product • Avoid contact with eyes • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure If pregnant or breast-feeding, ask a healthcare professional before use. 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 • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor • Limit sun exposure" ], "questions": [ "Questions? 1-800-900-6389 (24 hours a day, 7 days a week)" ], "spl_product_data_elements": [ "Esoterica Nighttime with Moisturizers hydroquinone hydroquinone hydroquinone water glyceryl monostearate isopropyl palmitate mineral oil ceresin propylene glycol stearyl alcohol polyethylene glycol 1500 poloxamer 188 steareth-20 laureth-23 sodium metabisulfite sodium lauryl sulfate anhydrous citric acid methylparaben dimethicone propylparaben edetate disodium butylated hydroxyanisole PROPYLENE GLYCOL MONOPALMITOSTEARATE" ], "ask_doctor": [ "Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor • For sensitive skin, test overnight on small area (inside elbow) • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a healthcare professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: MEDICIS The Dermatology Company ® Scottsdale, AZ 85256" ], "storage_and_handling": [ "Other information • Store at room temperature • Tamper-evident carton • Serious side effects may be reported to the phone number provided in the Questions? section below." ], "do_not_use": [ "Do not use • On inflamed or broken skin • On children under 12 years of age unless directed by a physician" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 70 g Carton Skin Lightener with Moisturizers NDC # 99207-290-02 E ESOTÉRICA ® ESOTÉRICA ® FADE CREAM NIGHTTIME With Moisturizers Net Wt. 2.5 oz (70 g) carton.jpg" ], "indications_and_usage": [ "Use Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptives." ], "set_id": "12adc34c-e65d-4679-b2c3-ab9ff5f615e8", "id": "8f190ff1-ad4c-4e71-9006-38aa705d381b", "active_ingredient": [ "Active ingredients Hydroquinone USP 2%" ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "MEDIQUE I-PRIN Ibuprofen SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST PLUS Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Dover Addaprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Otis Clapp Ultraprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Physicians Care Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Lab Safety Supply Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug Purpose Pain reliever/fever reducer Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever. Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain Questions or comments? 1-800-634-7680" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Medique® I-Prin Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 24 tablets (12 x 2) Compare active ingredient to Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 100 tablets (50 x 2) Compare active ingredient to: Genuine Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Plus Ibuprofen 200 mg See new warnings information Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets 250 tablets (125 x 2) Compare active ingredient to: Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Rapid Comfort SM Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film Coated Tablets Compare active ingredient to: Advil® Registered trademark of Whitehall-Robins See new warnings information 100 Tablets (50 x 2s) Tamper Evident Unit Dose Packets Dover Addaprin Pain Reliever-Fever Reducer Ibuprofen 200 MG. Tablets (NSAID) See new warnings information Dover Pharmaceutical Products of the highest quality and effectiveness Tamper Resistant Sealed Packets Unit Dose Packs 500 Tablets (250 Packets of 2) OC Otis Clapp Quality & Integrity Since 1840 Ultraprin ™ Pain Reliever-Fever Reducer (NSAID) Ibuprofen Tablets USP 200 mg For Deep Seated Pain See Warnings and directions on Side Panel See new warnings information Tear out along perforation to dispense Professional Healthcare 300 Tablets (150 Packets of 2) Physician's Care® Ibuprofen Anti-inflammatory, Fever Reducer & Pain Reliever (NSAID) Coated Tablets Compare active ingredient to: Advil® Registered trademark of Wyeth Corporation Tamper Evident Packets of 2 tablets See new warnings information Physicians Care® Registered trademark of Acme United Corporation 50 Packets (2 Tablets 200 mg Each) Medique Iprin Medi-First Ibuprofen Medi0First Plus Ibuprofen Lab Safety Ibuprofen Dover Addaprin Otis Clapp Ultraprin Physicians Care" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever." ], "set_id": "130baa8b-c8a0-4d72-94c9-6eb8dc8c7c29", "id": "07d899a0-08bc-57b3-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100218", "inactive_ingredient": [ "Inactive Ingredients: Cetearyl Alcohol, Mineral Oil, Paraffin, Sodium Lauryl Sulfate, Tocopheryl Acetate (vitamin E)." ], "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." ], "purpose": [ "Antiseptic" ], "warnings": [ "For external use only. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor." ], "spl_product_data_elements": [ "Thursday Plantation Tea Tree Antiseptic TEA TREE OIL TEA TREE OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: clean the affected area. apply small amount two or three times a day. may be covered with a sterile bandage." ], "stop_use": [ "Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs." ], "storage_and_handling": [ "store below 86 degrees F." ], "package_label_principal_display_panel": [ "Thursday Plantation Australia's Original Tea Tree Antiseptic With Vitamin E Distributed By: Integria Healthcare Australia Pty Ltd 8 Clunies Ross Court Eight Mile Plains, QLD 4113 Australia www.thursdayplantation.com USA Phone: 1-866-273-0377 Made in Australia Tea Tree Antiseptic Ointment Label" ], "indications_and_usage": [ "Uses: protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection." ], "set_id": "13902ab8-8562-4527-8ff9-82075002a41a", "id": "bbe03f6e-37db-49c2-8930-77727aba77bf", "active_ingredient": [ "Melaleuca Alternifolia (Tea Tree) Leaf Oil 5% ...... Antiseptic" ] }, { "effective_time": "20100726", "inactive_ingredient": [ "Inactive ingredients Sorbitol, Water, Hydrated Silica, Polyethylene Glycol 1450, Sodium Carboxymethylcellulose, Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Sodium Methylparaben, Mica, Propyparaben, Titanium Dioxide, D C Red 33, FD C Blue 1." ], "purpose": [ "PURPOSE Anticavity" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Walgreens Scooby Doo Fluoride Gel Toothpaste Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER SILICON DIOXIDE POLYETHYLENE GLYCOL 1450 CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFATE SACCHARIN SODIUM METHYLPARABEN SODIUM PROPYLPARABEN TITANIUM DIOXIDE D&C RED NO. 33 FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not swallow instruct children under 6 years in good rinsing habits (to reduce swallowing) supervise children as necessary until capable of using with our supervision adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or doctor children under 2 years: consult a dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "USE Aids in the prevention of dental decay." ], "set_id": "14039307-3fe6-4623-9709-1eccf3500f3e", "id": "33e7c7b7-299b-42c2-86e4-fcc30dbeb8b1", "active_ingredient": [ "Active Ingredients Sodium Fluoride 0.24% Anticavity" ] }, { "effective_time": "20130723", "inactive_ingredient": [ "INACTIVE INGREDIENTS croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Contains No Aspirin Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902" ], "spl_product_data_elements": [ "Arthritis Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE Capsule Shaped cor116" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date (Applicable only for Bottle Carton) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 66336-0233-XX EASY TO OPEN BOTTLE Use only as directed. See New Warnings Information Lasts up to 8 hours Arthritis Pain Relief Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) † Compare to the active ingredient of Tylenol ® Arthritis Pain † This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., The owner of the registered trademark Tylenol ® is the Tylenol Company. NDC 66336-0233-XX" ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "14a9db65-6d7b-4b06-ae03-93988ccc141d", "id": "8e39026d-40d6-4235-8422-08408281f3f6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age ask a doctor
" ] }, { "effective_time": "20130723", "inactive_ingredient": [ "Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E Acetate), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5" ], "purpose": [ "Handwash to help reduce bacteria that can potentially cause disease." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, seek medical help or contact Poison Control immediately." ], "warnings": [ "Avoid contact with eyes. If contact occurs, flush eyes with water. For external use only. Avoid contact with the eyes. If contact occurs, flush eyes with water. Discontinue use and consult a health practitioner if irritation develops. If swallowed seek medical help or contact Posion Control immediately. Keep out of reach of children." ], "spl_product_data_elements": [ "SoftCIDE-ES SoftCIDE-ES CHLOROXYLENOL CHLOROXYLENOL WATER EDETATE SODIUM POTASSIUM HYDROXIDE TALL OIL COCONUT ACID SODIUM LAURYL SULFATE COCO DIISOPROPANOLAMIDE PHENOXYETHANOL SODIUM SULFATE SODIUM LAURETH SULFATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL- IODOPROPYNYL BUTYLCARBAMATE D&C RED NO. 33 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Wet skin and apply a sufficient amount on hands and forearms. Scrub well and rinse thoroughly after washing." ], "package_label_principal_display_panel": [ "55863-281-27-ERI.jpg 55863-281-27-ERI.jpg", "55863-281-32-ERI.jpg 55863-281-32-ERI.jpg", "55863-281-32-VWR.jpg 55863-281-32-VWR.jpg", "55863-281-27-VWR.jpg 55863-281-27-VWR.jpg" ], "indications_and_usage": [ "Handwash to help reduce bacteria that can potentially cause disease. Avoid contact with the eyes. If contact occurs, flush eyes with water. Discontinue use and consult a health practitioner if irritation develops. If swallowed seek medical help or contact Posion Control immediately. Keep out of reach of children." ], "set_id": "152c8952-4fd6-4595-8039-502021c4f96e", "id": "5de72152-9b3f-426d-9916-df7e9ef384b4", "active_ingredient": [ "Chloroxylenol 0.3% w/w" ] }, { "effective_time": "20140624", "inactive_ingredient": [ "Inactive ingredients water, cetyl betaine, PPG-15 stearyl ether, sodium lauryl sulfate, glycerin, stearyl alcohol, distearyldimonium chloride, cetyl alcohol, steareth-21, behenyl alcohol, PPG-30, steareth-2, disodium EDTA.", "Inactive ingredients water, glycerin, PPG-15 stearyl ether, polymethylsilsesquioxane, dimethicone, isohexadecane, titanium dioxide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, decylene glycol, stearyl alcohol, cetyl alcohol, behenyl alcohol, cetearyl alcohol, cetearyl glucoside, dimethiconol, bisabolol, tocopheryl acetate, steareth-21, polysorbate 60, disodium EDTA, zingiber officinale (ginger) root extract." ], "purpose": [ "Purpose Acne treatment", "Purpose Acne Medication" ], "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 right away.", "Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Do not use on irritated or broken skin. Stop use and ask a physician if rash, irritation or sensitivity develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.", "Warnings For external use only. When using this product Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Do not use on irritated or broken skin. Stop use and ask a physician if rash, irritation or sensitivity develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. 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.", "When using this product Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. 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." ], "questions": [ "Questions or comments? 1-866-710-PROX (7769) www.olayprofessional.com", "Questions or comments? 1-866-710-PROX (7769) www.olayprofessional.com" ], "spl_product_data_elements": [ "Olay Professional ProX Clear Acne Protocol Salicylic Acid Olay Professional ProX Clear Pore Clarifying Cleanser Salicylic Acid Salicylic Acid Salicylic Acid water cetyl betaine sodium lauryl sulfate glycerin stearyl alcohol distearyldimonium chloride cetyl alcohol steareth-21 docosanol steareth-2 Edetate Disodium Olay Professional ProX Clear Skin Clearing Treatment Salicylic Acid Salicylic Acid Salicylic Acid water glycerin dimethicone isohexadecane titanium dioxide stearyl alcohol cetyl alcohol docosanol cetostearyl alcohol cetearyl glucoside levomenol steareth-21 polysorbate 60 Edetate Disodium ginger" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Wet face and apply a small amount of product to hands. Gently massage over entire face, avoiding eye area. Rinse thoroughly with warm water, pat dry. If bothersome dryness or peeling occurs, reduce frequency of application.", "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 doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day." ], "spl_unclassified_section": [ "PORE CLARIFYING CLEANSER Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202", "SKIN CLEARING TREATMENT Drug Facts", "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "stop_use": [ "Stop use and ask a physician if rash, irritation or sensitivity develops and lasts.", "Stop use and ask a physician if rash, irritation or sensitivity develops and lasts." ], "do_not_use": [ "Do not use on irritated or broken skin.", "Do not use on irritated or broken skin." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Kit Carton NEW OLAY ® PROFESSIONAL PRO X clear ACNE PROTOCOL 1 PORE CLARIFYING CLEANSER SALICYLIC ACID ACNE TREATMENT/CLEANSER 2 SKIN CLEARING TREATMENT SALICYLIC ACID ACNE TREATMENT 3 COMPLEXION RENEWING LOTION PORE CLARIFYING CLEANSER 2.5 FL OZ (75 mL) SKIN CLEARING TREATMENT 1.7 FL OZ (50 mL) COMPLEXION RENEWING LOTION 1.7 FL OZ (50 mL) PRINCIPAL DISPLAY PANEL - Kit Carton" ], "indications_and_usage": [ "Uses for the management of acne", "Uses for the treatment of acne helps clear up acne blemishes helps keep skin clear of new acne blemishes" ], "set_id": "15d8e141-4d75-4df3-bca5-9a190088fda6", "id": "5ff3eadd-1d3d-483c-bf65-dea8f17a87c0", "active_ingredient": [ "Active ingredient Salicylic Acid 1.8%", "Active ingredient Salicylic Acid 1.5%" ] }, { "effective_time": "20150512", "inactive_ingredient": [ "water, sodium laureth sulfate, sodium lauryl sulfate. Coco monoethanolamide, zinc carbonate, glycol distearate, dimethicone, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, benzyl alchohol, tocopheryl acetate, FD&C yellow No5, methylchloroisothiazolinonone, methyllisothiazolinone, FD&C blue No 1" ], "purpose": [ "PURPOSE Anti-drandruff" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN" ], "warnings": [ "FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT avoid contact with eyes If contact occurs, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF condition worsens or does not improve after regular use of this product as directed.\\ KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a poison control center right away." ], "spl_product_data_elements": [ "HEAD AND SHOULDERS BREAKEGE PREVENTION PYRITHIONE ZINC 1% PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCO MONOETHANOLAMIDE BENZYL ALCOHOL ALPHA-TOCOPHEROL ACETATE FD&C YELLOW NO. 5 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 ZINC CARBONATE GLYCOL DISTEARATE DIMETHICONE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM SULFATE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS for maximun drandruff control, use every time you shampoo wet hair, message onto scalp, rinse, repeat if desired For best results use al least twice a week or as directed by a doctor." ], "spl_unclassified_section": [ "DRUG FACTS" ], "user_safety_warnings": [ "USES Helps prevent recurrence of flaking and itching associated with drandruff Help prevent hair loss" ], "package_label_principal_display_panel": [ "hslp" ], "indications_and_usage": [ "DIRECTIONS FOR MAXIMUN DRANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO WET HAIR, MESSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR" ], "set_id": "15e90836-ae23-3979-e054-00144ff88e88", "id": "15e90836-ae24-3979-e054-00144ff88e88", "active_ingredient": [ "ACTIVE INGREDIENT PHYRITHIONE ZINC 1%" ] }, { "effective_time": "20140623", "inactive_ingredient": [ "Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, fragrance, cetyl alcohol, dimethicone, magnesium sulfate, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, camellia sinensis leaf extract, sodium xylenesulfonate, citrus grandis (grapefruit) peel oil, cymbopogon schoenanthus oil, yellow 5, blue 1." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions (or comments)? 1-800-723-9569" ], "spl_product_data_elements": [ "Head and Shoulders Citrus Breeze Pyrithione Zinc Pyrithione Zinc Pyrithione Zinc water sodium laureth-3 sulfate sodium lauryl sulfate coco monoethanolamide zinc carbonate glycol distearate cetyl alcohol dimethicone magnesium sulfate sodium benzoate magnesium carbonate hydroxide benzyl alcohol sodium chloride methylchloroisothiazolinone methylisothiazolinone green tea leaf sodium xylenesulfonate citrus maxima fruit rind oil cymbopogon schoenanthus oil fd&c yellow no. 5 fd&c blue no. 1" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp, rinse, repeat if desired. for best results use at least twice a week or as directed by a doctor." ], "spl_unclassified_section": [ "Drug Facts", "www.headandshoulders.com Dist. by Procter & Gamble, Cincinnati, OH 45202" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo IMPROVES HAIR & SCALP HEALTH GUARANTEED citrus breeze uplifting clean for fine/oily hair 14.2 FL OZ (420 mL) Principal Display Panel - 420 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "1632198e-5e8d-4a88-8193-ef486d2aabc4", "id": "841e3757-c6b9-4ece-a29a-d13caf2f1705", "active_ingredient": [ "Active ingredient Pyrithione zinc 1% Purpose Anti-dandruff" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "1649cdee-7ab0-430d-99f3-fb459d5854d9", "id": "24f2a5a6-c263-4bdd-b553-6ef52e80766c", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20141106", "inactive_ingredient": [ "Inactive Ingredients Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1." ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of Reach of children Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "questions": [ "Questions? +1-512-653-8814" ], "spl_product_data_elements": [ "FreshDent Cavity Protection Anticavity SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL GLYCERIN WATER SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM LAURYL SULFATE TITANIUM DIOXIDE SACCHARIN SODIUM METHYLPARABEN SODIUM FD&C BLUE NO. 1" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor." ], "package_label_principal_display_panel": [ "Package Label Anticavity Toothpaste FreshDent we care Cavity Protection Strengthens teeth with Active Fluoride Net Wt. 0.85 oz (24 g) Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt CavityBox CavityTube" ], "indications_and_usage": [ "Use Aids in the prevention of dental cavities" ], "set_id": "16ac653c-0bad-4d3b-a060-1be1444f28af", "id": "a5acc4f6-b53f-4a17-a889-ef681cfdf27b", "active_ingredient": [ "Active Ingredients Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)" ] }, { "effective_time": "20140701", "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever Pain reliever Pain reliever 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 (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 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 naussea 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 • facial swelling • shock • asthma (wheezing) Liver warning: This product contains acetaminophen. Severe lliver 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 Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • hae had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat. Do not use • if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or non prescription). 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 • stomach bleeding warning appies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis or kidney disease Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • taking any other drug or are under a doctor's care for any serious condition Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • have bloody or black stools • vomit blood • have stomach pain that does not get better • an allergic reaction occurs. Seek medical help right away. • any new symptoms appear • ringing in the ears or loss of hearing occurs • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • painful area is red or swollen If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (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." ], "questions": [ "Questions or comments? (800) 616-2471" ], "spl_product_data_elements": [ "Pain Reliever Plus Acetaminophen, Aspirin and caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE CROSPOVIDONE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONES PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE 44;159" ], "ask_doctor": [ "Ask a doctor before use if • you have liver disease • stomach bleeding warning appies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis or kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over • take 2 tablets every 6 hours • do not take more than 8 tablets in 24 hours • children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use 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 • you experience any of the following signs of stomach bleeding: • feel faint • have bloody or black stools • vomit blood • have stomach pain that does not get better • an allergic reaction occurs. Seek medical help right away. • any new symptoms appear • ringing in the ears or loss of hearing occurs • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • painful area is red or swollen" ], "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 ever had an allergic reaction to aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel MAJOR® COMPARE TO the active ingredients in EXCEDRIN® Extra Strength† PAIN RELIEVER PLUS Acetaminophen, Aspirin (NSAID) and caffeine Pain Reliever / Pain Reliever Aid TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING †This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excederin® Extra Strength. 50844 REV0713C15912 Distributed by MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-17 Rev. 08/13 Re-order No. 252831 Pain" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • sinusitis • toothache • premenstrual and menstrual cramps" ], "set_id": "17079b90-ccb2-4f35-8641-fdf3613d834f", "id": "17079b90-ccb2-4f35-8641-fdf3613d834f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • taking any other drug or are under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredients (in each tablets) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141229", "inactive_ingredient": [ "Inactive ingredients Water, TEA-Dodecylbenzenesulfonate, Sodium Laureth Sulfate, Sodium Methyl 2-Sulfopalmitate, Lauramine Oxide, Sodium Lauryl Sulfate, Alcohol Denat., Disodium 2-Sulfopalmitate, Methyl Palmitate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Red No. 33" ], "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. In case of eye contact, rinse thoroughly with water." ], "purpose": [ "Antibacterial hand soap" ], "warnings": [ "For external use only" ], "questions": [ "Questions or comments? 1-800-776-6702" ], "spl_product_data_elements": [ "Our Family Dish and Antibacterial Citrus Burst Scent Triclosan TRICLOSAN TRICLOSAN WATER TRIETHANOLAMINE DODECYLBENZENESULFONATE SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE ALCOHOL LAURAMINE OXIDE DISODIUM 2-SULFOPALMITATE METHYL PALMITATE EDETATE SODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SULISOBENZONE FD&C YELLOW NO. 5 D&C RED NO. 33" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wash hands and rinse" ], "package_label_principal_display_panel": [ "LBLFR LBLBK front label back label" ], "indications_and_usage": [ "Use helps fight germs on hands when used as a hand soap" ], "set_id": "182feec2-e869-40b2-95ff-98e6871f4427", "id": "a6cce003-e881-4954-9a8c-1f8681b542d9", "active_ingredient": [ "Active ingredient Triclosan 0.10% Use helps fight germs on hands when used as a hand soap For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. In case of eye contact, rinse thoroughly with water. Directions wash hands and rinse Antibacterial hand soap Inactive ingredients Water, TEA-Dodecylbenzenesulfonate, Sodium Laureth Sulfate, Sodium Methyl 2-Sulfopalmitate, Lauramine Oxide, Sodium Lauryl Sulfate, Alcohol Denat., Disodium 2-Sulfopalmitate, Methyl Palmitate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Red No. 33 Questions or comments? 1-800-776-6702" ] }, { "effective_time": "20120127", "inactive_ingredient": [ "Inactive ingredients glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C green no. 3" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-468-6502" ], "spl_product_data_elements": [ "Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION GLYCERIN HYDRATED SILICA WATER SODIUM BICARBONATE POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE SODIUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SACCHARIN SODIUM DIHYDRATE TITANIUM DIOXIDE FD&C GREEN NO. 3" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 232 g Tube Carton Colgate ® Fluoride Toothpaste Mint Zing Paste SPARKLING WHITE ® with Baking Soda & Peroxide WHITENS & PROTECTS TEETH FROM STAINS NET WT 8.2 OZ (232 g) Principal Display Panel - 232 g Tube Carton" ], "indications_and_usage": [ "Use helps protect against cavities" ], "set_id": "187111f6-36aa-420e-8273-0fe3b04e07b2", "id": "5b238118-7618-4de8-9426-a81418c86aa7", "active_ingredient": [ "Active ingredient Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)" ], "dosage_and_administration_table": [ "
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
" ] }, { "effective_time": "20121226", "inactive_ingredient": [ "Inactive ingredients *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain." ], "purpose": [ "Purpose Pain 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 : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma(wheezing) shock Stomach bleeding warning : This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery . Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Aspirin Enteric Safety Coated Aspirin ASPIRIN ASPIRIN DIACETYLATED MONOGLYCERIDES ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 HYPROMELLOSES HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE YELLOW METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL DIMETHICONE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE FD&C YELLOW NO. 6 E;HEART;81" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "other_safety_information": [ "Other information store at controlled room temperature 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 Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor children under 12 years of age: consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery ." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredient in Aspirin Regimen Bayer® 81 mg † SEE NEW WARNINGS INFORMATION Enteric safety Coated/ Aspirin regimen** **Ask your doctor before taking this product on a regular basis Aspirin 81 mg adult low strength Pain reliever (NSAID)* Low Dose Distributed by: American sales company 4201 Walden avenue, Lancaster, NY 14086 www.care1.info", "Product Label Aspirin 81 mg CareOne" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief." ], "set_id": "1877bc57-e5e0-431f-9d60-df3204245a6c", "id": "49f1fd90-884c-486c-87d4-f390a5b04093", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ] }, { "effective_time": "20150616", "inactive_ingredient": [ "WATER, SODIUM LAURYL SULFATE, SODIUM LAURETH SULDATE, GLYCOL DISTEARATE , ZINC CARBONATE, SODIUM CHLORIDE, SODIUM XYLENESULFONATE, COCAMIDOPROPYL BETAINE, FRAGANCE, DIMETHICONE, SODIUM BENZOATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1, RED 33" ], "purpose": [ "PURPOSE Anti-dandruff" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a poison control center rigth away." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT Avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF condition worsens or does not improve after regular use of this procuct as directed." ], "spl_product_data_elements": [ "HEAD AND SHOULDER MEN OLD SPICE PYRITHIONE ZINC WATER ZINC CARBONATE SODIUM CHLORIDE SODIUM XYLENESULFONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33 PYRITHIONE ZINC PYRITHIONE ZINC SODIUM LAURYL SULFATE SODIUM LAURETH-3 SULFATE METHYLCHLOROISOTHIAZOLINONE GLYCOL DISTEARATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS for best results use at least twice a week or as directed by doctor. for maximun dandruff control, use every time you shampoo shake bedore use wet hair, message onto scalp, rinse, repeat if desired." ], "user_safety_warnings": [ "USES Help prevent recurrence of flaking and itching associated with dan druff" ], "package_label_principal_display_panel": [ "pyrithione zinc HEAD AND SHOULDERS MEN OLD SPICE" ], "indications_and_usage": [ "HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "18a909f2-c5d0-2c42-e054-00144ff88e88", "id": "18a909f2-c5d1-2c42-e054-00144ff88e88", "active_ingredient": [ "DRUGS FACTS ACTIVE INGREDIENTS Pyrithione zinc 1%" ] }, { "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": "20150211", "inactive_ingredient": [ "Inactive Ingredients Glyceryl Monostearate Glyceryl Distearate Glycerin Stearic Acid Mineral Oil Petrolatum Paraffin Ceresin Beta Carotene Ethylparaben Sodium Lauryl Sulfate" ], "purpose": [ "Purpose Anti-Itch" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only. Avoid contact with the eyes. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "999 ITCH RELIEVING HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE GLYCERYL MONOSTEARATE GLYCERYL DISTEARATE GLYCERIN STEARIC ACID MINERAL OIL PETROLATUM PARAFFIN CERESIN BETA CAROTENE ETHYLPARABEN SODIUM LAURYL SULFATE" ], "other_safety_information": [ "Other Information Keep in a tightly closed container. Store at 8 to 30 ℃ (46-86℉) in a dry place away from sunlight. You may report serious side effects to: 1452 W. Holt Ave, Pomona, CA 91768" ], "openfda": {}, "version": "3102", "dosage_and_administration": [ "Directions Adult and children 2 years of age and older. Apply liberally to affected area not more than 5 times daily and 5-8 times per day for some severe cases or follow doctor's instruction." ], "pregnancy_or_breast_feeding": [ "Pregnant and children under 2 years of age. Do not use, consult a doctor." ], "stop_use": [ "Stop use and seek medical advice if Condition worsens. Symptoms persist for more than 7 days. Symptoms clear up and occur again within a few days. Excessive irritation of the skin develops." ], "spl_unclassified_section": [ "Manufactured By Guangdong CR. Shunfeng Pharmaceutical Co.; Ltd. Jinjuzu, Dalinag Street, Shunde District, Foshan, Guangdong, China 528300 Distributed by Master Herbs Inc. 1452 W. Holt Ave, Pomona, CA 91768 (866)487-8373" ], "package_label_principal_display_panel": [ "Drug Facts carton" ], "indications_and_usage": [ "Use For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: cosmetics, insect bites, psoriasis, eczema, seborrheic dermatitis." ], "set_id": "190a2618-f33d-4fe6-97e2-d145e88fdc2c", "id": "e99d3820-7f23-4d98-a41d-dcb141f80090", "active_ingredient": [ "ACTIVE INGREDIENTS Hydrocortisone 1.0%" ] }, { "effective_time": "20121114", "inactive_ingredient": [ "Inactive Ingredients INACTIVE INGREDIENTS: Hydrated Silica, Sorbitol, Deionized Water, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Lauryl Sulfate, Sodium Carboxymethylcellulose, Flavor, Sodium Saccharin." ], "purpose": [ "Purpose PURPOSE: Anticavity Toothpaste." ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "OraBrite SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION HYDRATED SILICA SORBITOL WATER METHYLPARABEN SODIUM PROPYLPARABEN SODIUM SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions DIRECTIONS: Adults and children 2 tears of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in god brushing and rinsing habits. (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor." ], "package_label_principal_display_panel": [ "Package Label Distributed by Oraline Inc., 823 NYS RT 13, Cortland, N.Y. 13045 OraBrite Mint Flavor with Fluoride NET WT 1.50 oz. Mfg. Date and Batch No. on crimp. Product of China, produced for Oraline. 888-296-6730. www.oraline.net Oraline OraBrite 2 Label" ], "indications_and_usage": [ "Use USE: Helps protect against cavities." ], "set_id": "19e89dc7-465a-4603-870b-84ddfdf52478", "id": "f22e9a97-1c45-472a-aee3-17c0a4223cbb", "active_ingredient": [ "Active Ingredient DRUG FACTS ACTIVE INGREDIENT: Sodium Fluoride 0.22% (Total Fluoride Content - 1000 ppm approx.)" ] }, { "effective_time": "20140610", "inactive_ingredient": [ "Inactive ingredients water, sodium lauryl sulfate, sodium laureth sulfate, lauramine oxide, sodium chloride, phenoxyethanol, PEI-14 PEG-10/PPG-7 copolymer, methylisothiazolinone, fragrance, yellow 5." ], "purpose": [ "Purpose Antibacterial hand soap" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings For external use only Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water." ], "when_using": [ "In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water." ], "questions": [ "Questions? 1-800-616-2392" ], "spl_product_data_elements": [ "Gain Ultra Lemon Zest Triclosan Triclosan Triclosan WATER SODIUM LAURYL SULFATE SODIUM LAURETH-3 SULFATE LAURAMINE OXIDE SODIUM CHLORIDE PHENOXYETHANOL METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse." ], "spl_unclassified_section": [ "DRUG FACTS", "Distributed by PROCTER & GAMBLE, CINCINNATI, OH 45202." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 887 mL Bottle Label ULTRA GAIN Ⓤ dishwashing liquid ANTIBACTERIAL HAND SOAP Lemon Zest 887 mL (1.87 PT) 30 FL OZ FPO 99611552 Principal Display Panel - 887 mL Bottle Label" ], "indications_and_usage": [ "Use For handwashing to decrease bacteria on the skin" ], "set_id": "1a2291e4-10dc-47c6-9342-65897be4dde9", "id": "c3f63af3-e532-4b2c-b647-d7341dc9bceb", "active_ingredient": [ "Active Ingredient Triclosan 0.10%" ] }, { "effective_time": "20110221", "inactive_ingredient": [ "OTHER INGREDIENTS Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl Myristate, Glycerin, Sodium Lauryl Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5" ], "purpose": [ "PURPOSE Analgesic/Counterirritant Analgesic/Counterirritant External Analgesic" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Consult physician for children under 12." ], "warnings": [ "WARNINGS For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not cover with bandage. Do not use on wounds or damaged skin." ], "spl_product_data_elements": [ "Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN METHYL SALICYLATE SALICYLIC ACID MENTHOL MENTHOL CAPSAICIN CAPSAICIN WATER CETYL ALCOHOL PEG-150 DISTEARATE ISOPROPYL MYRISTATE GLYCERIN SODIUM LAURYL SULFATE POLYSORBATE 20 TROLAMINE PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN DIAZOLIDINYL UREA FD&C BLUE NO. 1 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day." ], "spl_unclassified_section": [ "DRUG FACTS:" ], "package_label_principal_display_panel": [ "MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT Label Image" ], "indications_and_usage": [ "USES Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness." ], "set_id": "1a2a7a30-9a6e-46b9-87a9-819a1ef3b78f", "id": "a5301358-a8cd-436a-abb5-0494b1e5f15c", "active_ingredient": [ "ACTIVE INGREDIENTS Methyl Salicylate 20.00% Menthol 5.00% Capsaicin 0.0375%" ] }, { "effective_time": "20140725", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE SODIUM CHLORIDE GLYCOL DISTEARATE ZINC CARBONATE COCAMIDOPROPYL BETAINE DIMETHICONE SODIUM XYLENESULFONATE MAGNESIUM SULFATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "1a775c68-0901-4a31-8bed-2ac6667de40f", "id": "549e24f3-0b83-42ae-a177-74c45bfaa5b2", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20101109", "inactive_ingredient": [ "Inactive Ingredients Water, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Decyl Polyglucose, Sodium Chloride, Fragrance (Parfum), DMDM Hydantoin, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Polyquaternium-7, PEG- 7 Glyceryl Cocoate, Red 33 (CI 17200), Blue 1 (CI 42090)." ], "purpose": [ "Purpose Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of accidental ingestion, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only. When using this product - Avoid contact with eyes. If contact occurs, rinse with water. Stop using this product and ask doctor if - 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." ], "when_using": [ "When using this product - Avoid contact with eyes. If contact occurs, rinse with water." ], "spl_product_data_elements": [ "IMAGE ESSENTIALS Antibacterial TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE COCO MONOETHANOLAMIDE SODIUM CHLORIDE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) DMDM HYDANTOIN EDETATE SODIUM CITRIC ACID MONOHYDRATE PEG-120 METHYL GLUCOSE DIOLEATE FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply onto wet hands, work into a lather, rinse thoroughly." ], "stop_use": [ "Stop using this product and ask doctor if - irritation or redness develops and lasts." ], "package_label_principal_display_panel": [ "Package Front and Back Labels IE.jpg F-B LABELS" ], "indications_and_usage": [ "Uses Helps reduce bacteria on the skin" ], "set_id": "1b099e1e-9bbc-490b-a3e1-44551cb3e1fb", "id": "f0da44e2-affd-4e9b-99e6-0c6c3d0444df", "active_ingredient": [ "Active Ingredient Triclosan 0.115%" ] }, { "effective_time": "20120224", "inactive_ingredient": [ "Inactive Ingredients Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide." ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems high blood pressure heart or kidney disease taken a diuretic reached age 60 or older Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs long term continuous use ay increase the risk of heart attack or stroke Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IP;140" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Dosage & Administration do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in a 24-hour period Children under 12 years ask a doctor Other information store at 20 – 25°C (68 – 77°F). Read all warnings and directions before use Questions or Comments? Call 1-877-835-5472 Monday though Friday 9AM – 5PM EST." ], "spl_unclassified_section": [ "*Compared to the active ingredient of Advil ® Drug Facts", "Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141", "*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil ® Rev. 10-2008" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Ibuprofen Tabs, USP 200mg Principal Display Panel-Ibuprofen Tablets, USP 200mg" ], "indications_and_usage": [ "Indications & Usage temporarily relieves minor aches and pains due to: headache muscular aches minor pain or arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "1b2ab0e2-ed21-4df8-bed2-55728a505c7d", "id": "915618ec-ed9f-4094-a144-dfae11a60690", "active_ingredient": [ "ACTIVE INGREDIENT (in each Tablet) Ibuprofen 200 mg (NSAID)** **nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in a 24-hour period
Children under 12 years ask a doctor
" ] }, { "effective_time": "20111109", "purpose": [ "Purpose Pain reliever/fever reducer Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed" ], "questions": [ "Questions or comments? call toll-free 1-800-245-1040 (English/Spanish) weekdays TAMPER-EVIDENT PACKAGING FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108, Made in Ireland ©2010 GlaxoSmithKline CONTAC® is a registered trademark of the GlaxoSmithKline group of companies. Retain outer carton for complete directions and warnings." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store below 25°C (77°F)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to the common cold or flu: nasal congestion minor aches and pains sinus congestion and pressure headache stuffy nose sore throat temporarily reduces fever" ], "set_id": "1b3db689-5878-48b6-8f22-550276cc2a7d", "id": "01873e25-14b9-4f9f-b8c1-993081b1be11", "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 500mg Phenylephrine hydrochloride 5mg" ], "inactive_ingredient": [ "Inactive ingredients hypromellose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, sodium lauryl sulfate, starch, stearic acid, talc" ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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, ask a doctor promptly Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if you get nervous, dizzy or sleepless pain or nasal congestion gets worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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 can cause serious health problems. 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." ], "spl_product_data_elements": [ "CONTAC acetaminophen and phenylephrine ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POTASSIUM SORBATE POVIDONE SODIUM LAURYL SULFATE STEARIC ACID TALC MS" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets every 6 hours as needed do not take more than 8 caplets in 24 hours children under 12 years of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain or nasal congestion gets worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear" ], "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 CONTAC ® COLD +FLU NASAL DECONGESTANT/PAIN RELIEVER-FEVER REDUCER MAXIMUM STRENGTH NON-DROWSY RELIEF OF: >Nasal Congestion >Phenylephrine >Headaches, Sore Throat, Fever >Acetaminophen See new warnings information. NET CONTENTS: 24 CAPLETS 1000178XA Contac Cold and Flu Carton" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose can cause serious health problems. 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." ] }, { "effective_time": "20100830", "inactive_ingredient": [ "INACTIVE INGREDIENTS benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate." ], "purpose": [ "PURPOSE Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222" ], "warnings": [ "WARNINGS Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland. Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative. When using this product you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine. If pregnant or breast-feeding, 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 you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine." ], "questions": [ "QUESTIONS OR COMMENTS? Distributed by: Qualitest Pharmaceuticals, Inc. 130 Vintage Drive Huntsville, AL 35811 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE" ], "ask_doctor": [ "Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION Store at controlled room temperature 59-86 degrees F." ], "package_label_principal_display_panel": [ "Package Label 25 mg Capsules 25 mg Capsules" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose." ], "set_id": "1b53ec3a-dec0-48c2-831d-72b3d88242f1", "id": "1b53ec3a-dec0-48c2-831d-72b3d88242f1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPSULE) Diphenhydramine Hydrochloride 25 mg" ] }, { "effective_time": "20100825", "inactive_ingredient": [ "Inactive ingredients: Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Sodium Phosphate, Sodium Saccharin, Methyl Cellulose, Titanium Dioxide, Blue 1." ], "purpose": [ "Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS As with all fluoride toothpastes, keep out of reach of children under 6 years of age . If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "Up and Up Anticavity Toothpaste Whitening Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER SILICON DIOXIDE SODIUM LAURYL SULFATE CROSCARMELLOSE SODIUM SODIUM PYROPHOSPHATE SODIUM PHOSPHATE SACCHARIN SODIUM TITANIUM DIOXIDE FD&C BLUE NO. 1 bold mint flavor" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years and older Brush teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist. Do not swallow. Children under 6 years of age To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years Ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel image of container" ], "indications_and_usage": [ "USE Helps protect against cavities" ], "set_id": "1cb8693e-5601-441e-b228-71de1c6d6906", "id": "a4b74051-aca6-4926-a464-41bf4539d968", "active_ingredient": [ "Active Ingredients Sodium Fluoride 0.243% (0.14% w/v fluoride ion)... Anticavity toothpaste" ] }, { "effective_time": "20151021", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Cellulose Gum, D&C Yellow No. 10, FD&C Blue No. 1, Flavor, Glycerin, Mica (and) Titanium Dioxide, Poloxamer 234, Silica, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Water, Xylitol" ], "instructions_for_use": [ "Tube Label Tube Label Tube Label" ], "spl_product_data_elements": [ "Fluoridex Daily Defense Clean Mint 5000ppm Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION CARBOXYMETHYLCELLULOSE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MINT GLYCERIN MICA TITANIUM DIOXIDE POLOXAMER 234 SILICON DIOXIDE SODIUM LAURYL SULFATE SACCHARIN SODIUM SORBITOL WATER XYLITOL with sparkles" ], "warnings_and_cautions": [ "WARNINGS AND PRECAUTIONS DO NOT SWALLOW. Keept out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product." ], "openfda": {}, "version": "4", "dosage_and_administration": [ "DIRECTIONS FOR USE: This prescription toothpaste is recommended for adults and children 6 years of age and older. Use twice daily as your normal dentifrice or as directed by your dental professional. Apply a thin ribbon or pea-sized amount of Fluoridex Daily Defense® Sensitivity Relief Toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute. After use, adults expectorate. For best results do not eat, drink, or rinse for 30 minutes. Pediatric patients age 6-16, expectorate after use and rinse mouth thoroughly." ], "storage_and_handling": [ "STORAGE AND HANDLING SECTION: Store at controlled room temperature 15°-30°C (59°-86°F)" ], "package_label_principal_display_panel": [ "Outer Carton Outer Carton Outer Carton Tube Label Tube Label Tube Label" ], "indications_and_usage": [ "INDICATIONS AND USAGE: Prescription fluoride toothpaste for use as part of a professional program for the prevention and control of dental caries." ], "set_id": "1d511132-c366-4c9a-aee7-584e6420fb27", "id": "b7fa3ef5-1f76-4381-83b3-a3332d061d3c" }, { "effective_time": "20140221", "inactive_ingredient": [ "Inactive ingredients cetearyl alcohol, cocamidopropyl betaine, dimethyl isosorbide, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide, zea mays (corn) starch." ], "purpose": [ "Purpose Acne medication" ], "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 if you • have very sensitive skin • are sensitive to benzoyl peroxide When using this product • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth. • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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. • 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. Stop use and ask a doctor if • irritation becomes severe. 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 unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth. • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by 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. • 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." ], "questions": [ "Questions? Call 1-888-438-7426. Side effects should be reported to this number." ], "spl_product_data_elements": [ "Elette benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL COCAMIDOPROPYL BETAINE DIMETHYL ISOSORBIDE GLYCERIN GLYCOLIC ACID HYDROGENATED CASTOR OIL IMIDUREA LACTIC ACID METHYLPARABEN MINERAL OIL POLYETHYLENE GLYCOL 600000 POTASSIUM LAURYL SULFATE POTASSIUM PHOSPHATE, UNSPECIFIED FORM WATER SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM PYRROLIDONE CARBOXYLATE TITANIUM DIOXIDE STARCH, CORN" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • Wet area to be cleansed. • Apply acne wash and gently massage area for 1-2 minutes. • Rinse thoroughly and pat dry. • 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 going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor." ], "stop_use": [ "Stop use and ask a doctor if • irritation becomes severe." ], "spl_unclassified_section": [ "Other information Store at room temperature 59°F to 86°F (15°C to 30°C)." ], "do_not_use": [ "Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0145-2836-46 ELETTE™ creamy wash benzoyl peroxide, 4% Lathering creamy cleanser Hydrates the skin • Gently removes impurities • Clears Blemishes • Reduces Irritation • Defends against future breakouts Net Wt 6 oz (170.1 g) ELETTE is a trademark of Stiefel Laboratories, Inc. ©2012 Stiefel Laboratories, Inc Made in Canada Rev. 2/12 Stiefel Laboratories, Inc Research Triangle Park, NC 27709 10000000103873 Elette Wash 6 oz carton" ], "indications_and_usage": [ "Use For the treatment of acne" ], "set_id": "1d5d86d5-fa03-4808-b29b-a935b8c068c3", "id": "a0e95252-99ad-46d1-9405-01f2a2c9ba26", "active_ingredient": [ "Active ingredient Benzoyl peroxide 4%" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, DIMETHICONE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, SODIUM XYLENESULFONATE, FRAGRANCE (PARFUM), CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "spl_product_data_elements": [ "TOPCARE GENTLE DANDRUFF DRY SCALP PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE DIMETHICONE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE SODIUM XYLENESULFONATE CETYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) MAGNESIUM SULFATE SODIUM CHLORIDE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL ALMOND OIL CITRIC ACID MONOHYDRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED" ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY" ], "package_label_principal_display_panel": [ "LABEL COPY IMAGE OF THE LABEL" ], "indications_and_usage": [ "USES TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "1e001641-4006-403a-ab1c-36afdd0dd96d", "id": "70f2d090-d0e6-4aa4-a921-66e89b2eb3c9", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1% PURPOSE ANTI-DANDRUFF" ] }, { "effective_time": "20110512", "inactive_ingredient": [ "Inactive Ingredients Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S." ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a poison control center immediately." ], "warnings": [ "Warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a poison control center immediately." ], "spl_product_data_elements": [ "Amerfresh Sodium Monofluorophosphate Sodium Monofluorophosphate fluoride ion Calcium Carbonate Carboxymethylcellulose Sodium Saccharin Sodium Sodium Lauryl Sulfate Methylparaben Sodium Propylparaben Sodium Silicon Dioxide Ponceau 4R" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing. Children under 2 years Ask a Dentist or physician." ], "spl_unclassified_section": [ "DRUG FACTS", "Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 446 g Carton AMERFRESH ® FLUORIDE TOOTHPOWDER NET WEIGHT 1 lb (446 g) Principal Display Panel - 446 g Carton" ], "indications_and_usage": [ "Use helps protect against cavities" ], "set_id": "1e09d9ed-b8e2-4998-845b-93ed861542be", "id": "843e8d6b-8bb6-4c81-8089-8a500ebe6bd4", "active_ingredient": [ "Active Ingredient Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)" ], "dosage_and_administration_table": [ "
Adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 years Ask a Dentist or physician.
" ] }, { "effective_time": "20140930", "inactive_ingredient": [ "INACTIVE INGREDIENTS corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate." ], "purpose": [ "PURPOSE Pain 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 : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do Not Use if you are allergic to aspirin or other pain relievers/fever reducers Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning the blood) diabetes gout arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Enteric Coated Aspirin Regular Strength ASPIRIN ASPIRIN STARCH, CORN DIMETHICONE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 TITANIUM DIOXIDE TALC TRIETHYL CITRATE SODIUM HYDROXIDE FD&C YELLOW NO. 6 POLYSORBATE 80 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SODIUM LAURYL SULFATE MINERAL OIL T" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically 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 an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts for more than 10 days" ], "spl_unclassified_section": [ "OTHER INFORMATION store at room temperature do not use if imprinted safety seal under cap is broken or missing You may report serious side effects to: 1-888-952-0050", "SUPPLIER STATEMENT This Product was Manufactured By: Qualitest Pharmaceuticals, Inc Huntsville, AL USA And Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 USA" ], "do_not_use": [ "Do Not Use if you are allergic to aspirin or other pain relievers/fever reducers" ], "package_label_principal_display_panel": [ "PACKAGE LABEL Label Image for 53808-1034 325mg Label Image for 325mg" ], "indications_and_usage": [ "USES for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief." ], "set_id": "1f43b07a-1f6f-48f1-a05b-210c2c0d9a1e", "id": "9916a3b5-9e92-4248-8709-a4f0a265f39a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning the blood) diabetes gout arthritis" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH TABLET) Aspirin 325mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120924", "purpose": [ "Active ingredients (in each gelcap) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-877-717-2824 or www.benadryl.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. tamper evident statement see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies: runny nose nasal congestion headache sore throat cough sneezing minor aches and pains itchy, watery eyes itching of the nose or throat sinus congestion and pressure temporarily reduces fever" ], "set_id": "1fb8243d-2249-4898-ab99-1f0dd6f122b0", "id": "0fa83c5d-a031-4be0-8db8-a730256ff562", "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 gelcap) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, corn starch, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, edetate calcium disodium, FD&C red #40, FD&C yellow #6, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 gelcaps 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. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Benadryl Allergy Plus Cold Acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride Acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine benzyl alcohol ferrosoferric oxide butylparaben carboxymethylcellulose sodium starch, corn D&C red no. 28 D&C yellow no. 10 aluminum oxide edetate calcium disodium FD&C red no. 40 FD&C yellow no. 6 gelatin hypromelloses magnesium stearate methylparaben cellulose, microcrystalline polyethylene glycols polysorbate 80 propylparaben ferric oxide red sodium citrate sodium lauryl sulfate sodium propionate sodium starch glycolate type a potato titanium dioxide ferric oxide yellow grey subcoat; gelatin dipped Ben;AC" ], "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 or emphysema cough accompanied by too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each gelcap) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each gelcap) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20110726", "inactive_ingredient": [ "Inactive ingredients cellulose, citric acid, dibasic sodium phosphate, hydrogenated vegetable oil, hypromellose, propylene glycol, simethicone, sodium lauryl sulfate, starch, talc, titanium dioxide" ], "purpose": [ "Purposes Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings 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 skin reddening facial swelling rash asthma (wheezing) blisters shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "MEDIQUE Tri Buffered Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE DIMETHICONE HYPROMELLOSES PROPYLENE GLYCOL SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC STARCH, CORN TALC TITANIUM DIOXIDE white ROUND 44;183 MEDI-FIRST Tri Buffered Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE DIMETHICONE HYPROMELLOSES PROPYLENE GLYCOL SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC STARCH, CORN TALC TITANIUM DIOXIDE white ROUND 44;183 Medi First Plus Tri Buffered Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE DIMETHICONE HYPROMELLOSES PROPYLENE GLYCOL SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM PHOSPHATE, DIBASIC STARCH, CORN TALC TITANIUM DIOXIDE white ROUND 44;183" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children (12 years and older): Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "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." ], "spl_unclassified_section": [ "Drug Facts", "Other information each tablet contains 36.0 mg of calcium and 39.3 mg of magnesium read all product information before using store at room temperature 59º-86ºF (15º-30ºC) 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 you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "119R Medique Tri-Buff Aspirin Label Medique® Collect MediBucks See inside flap for details Tri-Buffered Aspirin 5 Grain (325mg) Pain Reliever/Fever Reducer (NSAID) Alivia el Dolor/Reduce la Fiebre (AINE) 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) 119R Medique Tri-Buff Aspirin Label", "119R MF Tri-Buff Aspirin Label Medi-First® 250 Tablets (125 x 2) Tri-Buffered Aspirin 5 Grain (325mg) See new warnings information Pain Reliever/Fever Reducer (NSAID) Pull to Open Easy To Swallow Film Coated Tablets Compare active ingredients to: Bufferin® Registered Trademark of Bristol-Myers Tamper Evident Unit Dose Packets 119R MF Tri-Buff Aspirin Label", "119R MFP Tri-Buff Aspirin Label Medi-First Plus ® 100 Tablets (50 x 2's) Tri-Buffered Aspirin 5 Grain (325mg) Pain Reliever/Fever Reducer (NSAID) Pull to Open Easy To Swallow Film Coated Tablets See new warnings information Compare active ingredients to: Bufferin® Registered Trademark of Bristol Myers Tamper Evident Unit Dose Packets 119R MFP Tri-Buff Aspirin Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache muscular aches minor arthritis pain backache common cold toothache menstrual cramps Temporarily reduces fever." ], "set_id": "1fbb2587-9d86-470b-b44d-c6f072b403ab", "id": "40b72315-dc85-4611-9fb7-0729f3ddc616", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 325mg (NSAID*) (Buffered with Calcium Carbonate, Magnesium Carbonate and Magnesium Oxide) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100701", "inactive_ingredient": [ "Inactive Ingredients Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide MEA, Zinc Carbonate, Glycol Distearate, Dimethicone, Fragrance (Parfum), Cetyl Alcohol, Polyquaternium-10, Magnesium Sulfate, Sodium Benzoate, Magnesium Carbonate Hydroxide, Ammonium Laureth Sulfate, Benzyl Alcohol, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Xylenesulfonate" ], "purpose": [ "PURPOSE ANTI-DANDRUFF" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER. STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY." ], "when_using": [ "WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER." ], "spl_product_data_elements": [ "Equaline Dandruff Dry Scalp 2 in 1 PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR, MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRE." ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED" ], "package_label_principal_display_panel": [ "PACKAGE FRONT AND BACK LABELS 14OZ Front and Back Labels: eql14.jpg 14 OZ FRONT AND BACK LABELS" ], "indications_and_usage": [ "Uses HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF" ], "set_id": "20e034ee-9540-4488-8293-5bbea7c4d2c7", "id": "7a9624ff-65e7-4cbb-bc3f-cea0a6dfc521", "active_ingredient": [ "ACTIVE INGREDIENT PYRITHIONE ZINC 1%" ] }, { "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": "20140916", "purpose": [ "Active ingredients (in each geltab) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton is opened, or neck wrap or foil inner seal imprinted \"SAFETY SEAL®\" is broken or missing see end panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "set_id": "21e6ce85-91f2-492b-b60b-84de9a38a3a6", "id": "6ccc2cf4-d199-44c9-a52d-d44ce64f3920", "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 geltab) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 geltabs at bedtime do not take more than 2 geltabs of this product in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, butylparaben, castor oil, D&C red no. 28, edetate calcium disodium, FD&C blue no. 1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, simethicone, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine benzyl alcohol butylparaben castor oil D&C red No. 28 edetate calcium disodium FD&C blue No. 1 gelatin hypromelloses magnesium stearate methylparaben powdered cellulose propylene glycol propylparaben shellac sodium citrate sodium lauryl sulfate sodium propionate sodium starch glycolate type A potato titanium dioxide white and blue geltab printed TYLENOL PM in gray ink TYLENOL;PM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 geltabs at bedtime do not take more than 2 geltabs of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each geltab) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL My-CoachSleep ™ EXCLUSIVE ACCESS FREE WITH PURCHASE NDC 50580-176-10 See New Warnings Information & Directions Extra Strength TYLENOL ® PM Non-habit forming Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl 100 GELTABS Geltabs* * Gelatin-Coated Tablets PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each geltab) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ] }, { "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": "20130411", "inactive_ingredient": [ "Inactive ingredients sorbitol, water, silica, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium benzoate, sodium phosphate, tetrasodium pyrophosphate, sodium saccharin." ], "purpose": [ "Purpose Builds increasing protection against painful sensitivity of teeh due to cold, heat, acids, sweets or contact Aids in the prevention of dental cavities" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use." ], "spl_product_data_elements": [ "Family Wellness Sensitive Extra Whitening Potassium Nitrate and Sodium Fluoride POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER SODIUM LAURYL SULFATE TITANIUM DIOXIDE SODIUM BENZOATE SODIUM PHOSPHATE SACCHARIN SODIUM Sensitive" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and older Brush teeth for at least one minute, preferably after each meal, or at least twice a day or as directed by your dentist. Be sure to brush sensitive areas of the teeth. Children under 12 years of age Consult a dentist or doctor Other information Store in a cool, dry place." ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "USES Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact Aids in the prevention of dental cavities" ], "set_id": "22b5d423-b43a-4be9-be98-998640ff1c13", "id": "f06fee99-2d1b-4adf-a5a0-9e90db64a461", "active_ingredient": [ "Active Ingredients Potassium nitrate 5%........................................... Antihypersensitivity Sodium Fluoride 0.243% (0.15% w/v fluoride ion).... Anticavity toothpaste" ] }, { "effective_time": "20111031", "inactive_ingredient": [ "Inactive Ingredients: Calcium Carbonate, Water, Sorbitol, Sodium Lauryl Sulfate, Silica, Carboxymethyl Cellulose, Flavor, Potassium Nitrate, Sodium benzoate, Sodium saccharin, menthol" ], "purpose": [ "Anticavity" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "If you accidentally swallow more than is used for brushing, seek professional assistance or contact a Poison Control Center immediately." ], "spl_product_data_elements": [ "MEDICHOICE ANTICAVITY FLUORIDE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION CALCIUM CARBONATE WATER SORBITOL SODIUM LAURYL SULFATE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE POTASSIUM NITRATE SODIUM BENZOATE SACCHARIN SODIUM MENTHOL" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "Directions: Adults and children 2 yrs and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 yrs: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician. If you accidentally swallow more than is used for brushing, seek professional assistance or contact a Poison Control Center immediately. Keep out of reach of children" ], "spl_unclassified_section": [ "Expiration Date: Expiration Date and Batch No. on crimp of Tube", "E.c No.: DD/COS/DD/C/52 Made in India MediChoice Reorder: 2002PC7306 Distributed by: Owens and Minor Mechanicsville, VA 23116 804.723.7000" ], "package_label_principal_display_panel": [ "tube6oz", "MEDICHOICE Reorder: 2002PC7306 Anticavity Fluoride Toothpaste 0.6 oz Contents: 144/bx Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "box6", "Medichoice Reorder: 2002PC7306 Anticavity Fluoride Toothpaste 0.6 Contents: 144/bx, 5 boxes/cs, 720 cs Distributed by Owens and Minor Mechanicsville, VA 23116 Made in India", "case6" ], "indications_and_usage": [ "Use: Aids in the prevention of dental cavities." ], "set_id": "22c756b9-4141-4c0f-a411-f142a9cff203", "id": "b814858a-6761-47af-947a-f6e4c680bfeb", "active_ingredient": [ "DRUG FACTS Active Ingredient: Purpose Sodium Fluoride 0.22% Anticavity Anticavity" ] }, { "effective_time": "20141229", "inactive_ingredient": [ "Inactive ingredients Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Lauramine Oxide, Sodium Dodecylbenzenesulfonate, Sodium Xylene Sulfonate, Alcohol Denat., Fragrance, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue No. 1, Yellow No. 5" ], "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. In case of eye contact, rinse thoroughly with water." ], "purpose": [ "Antibacterial hand soap" ], "warnings": [ "For external use only" ], "questions": [ "Questions? 1-800-776-6702" ], "spl_product_data_elements": [ "Publix UltraDish Detergent Green Apple Scent Triclosan TRICLOSAN TRICLOSAN WATER SODIUM DODECYLBENZENESULFONATE SODIUM LAURYL SULFATE SODIUM LAURETH SULFATE ALCOHOL LAURAMINE OXIDE SODIUM XYLENESULFONATE SODIUM CITRATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SULISOBENZONE FD&C YELLOW NO. 5 FD&C BLUE NO. 1" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wash hands and rinse" ], "package_label_principal_display_panel": [ "LBLFR LBLBK front label back label" ], "indications_and_usage": [ "Use helps fight germs on hands when used as a hand soap" ], "set_id": "230320e1-4011-4fdd-a253-5d3f5098746e", "id": "00aa6fa8-9db2-4cac-a4e4-bdede3f7bb8d", "active_ingredient": [ "Active ingredient Triclosan 0.10% Use helps fight germs on hands when used as a hand soap For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. In case of eye contact, rinse thoroughly with water. Directions wash hands and rinse Antibacterial hand soap Inactive ingredients Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Lauramine Oxide, Sodium Dodecylbenzenesulfonate, Sodium Xylene Sulfonate, Alcohol Denat., Fragrance, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Blue No. 1, Yellow No. 5 Questions? 1-800-776-6702" ] }, { "effective_time": "20131122", "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "Purpose Pain 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 (1-800-222-1222)." ], "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 or 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 inclue: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed" ], "questions": [ "Questions? To Report Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Regular Strength Aspirin EC Aspirin ASPIRIN ASPIRIN STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYSORBATE 80 SILICON DIOXIDE DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE T" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have not been drinking fluids" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear ringing in the ears or a loss of hearing occurs" ], "storage_and_handling": [ "Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package" ], "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 LABEL" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains due to headache colds muscle pain menstrual pain toothache minor pain of arthritis or as directed by your doctor" ], "set_id": "2316a3ab-b36b-4fc0-9370-b792eef4ad12", "id": "0d38a94d-5641-4615-96ee-28363bda0515", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drugs under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each tablet) Purpose Aspirin 325 mg (NSAID*).............................Pain reliever *nonsteroidal anti-inflammatory drug Purpose Pain reliever" ] }, { "effective_time": "20111215", "inactive_ingredient": [ "Inactive Ingredients Butyl Avocadate, Cetyl Hydroxyethylcellulose, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Fragrance, Menthol, Menthyl Lactate, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Ext. Violet 2 (CI 60730), Water (Aqua)." ], "purpose": [ "Purpose Acne treatment gel" ], "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 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 doctor. Stop use and ask a doctor if irritation becomes severe. 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 doctor." ], "questions": [ "Questions? (800) 636-7546 Mon-Fri 9:00 am – 4:00 p.m. Pacific Time" ], "spl_product_data_elements": [ "CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID SODIUM LAURETH SULFATE DIETHYLENE GLYCOL MONOETHYL ETHER SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE CETYL HYDROXYETHYLCELLULOSE (350000 MW) EDETATE DISODIUM MENTHOL MENTHYL LACTATE EXT. D&C VIOLET NO. 2 WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Use AM and PM. Wet face. Gently massage product all over face for 20-30 seconds avoiding eye area. Rinse thoroughly and pat dry. Wait 10-15 minutes to allow skin to dry completely." ], "spl_unclassified_section": [ "DRUG FACTS", "Dist. by OMP, Inc., Long Beach, CA 90806" ], "stop_use": [ "Stop use and ask a doctor if irritation becomes severe." ], "storage_and_handling": [ "Other Information store away from heat and direct sunlight. store at controlled room temperature: 15°-25°C (59°-77°F)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label OBAGI ® CLENZI derm M.D.™ Daily Care Foaming Cleanser SALICYLIC ACID 2 % ACNE TREATMENT 1 Removes dirt and excess oil, leaving skin clean and refreshed. 4 FL.OZ. (118 mL) Principal Display Panel - 118 mL Bottle Label" ], "indications_and_usage": [ "Uses For the treatment of acne dries up acne pimples helps prevent new acne pimples" ], "set_id": "23625de5-003c-446d-a661-b245cffbe4a0", "id": "209d04e7-f03e-4697-9a04-f0d7026bdba0", "active_ingredient": [ "Active Ingredient Salicylic Acid 2%" ] }, { "effective_time": "20150319", "inactive_ingredient": [ "Inactive ingredients Water, sodium laureth sulfate, sodium lauryl sulfate, dimethicone, cocamide MEA, zinc carbonate, glycol distearate, sodium xylenesulfonate, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone." ], "purpose": [ "Purpose Anti-dandruff" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water." ], "questions": [ "Questions (or comments)? 1-800-723-9569" ], "spl_product_data_elements": [ "Head and Shoulders 2in1 Smooth and Silky Pyrithione Zinc WATER SODIUM LAURETH-3 SULFATE SODIUM LAURYL SULFATE DIMETHICONE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE SODIUM XYLENESULFONATE CETYL ALCOHOL MAGNESIUM SULFATE SODIUM CHLORIDE SODIUM BENZOATE MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE PYRITHIONE ZINC PYRITHIONE ZINC" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp, rinse, repeat if desired. for best results use at least twice a week or as directed by a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: IMPULSORA SAHUAYO S.A. DE C.V. ASTROLOGOS # 14104 INDICO TIJUANA B.C. MEX, www.headandshoulders.com" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo + conditioner IMPROVES HAIR & SCALP HEALTH GUARANTEED 2in1 smooth & silky restores a silky smooth look to dry frizzy hair 14.2 FL OZ (420 mL) PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label" ], "indications_and_usage": [ "Uses helps prevent recurrence of flaking and itching associated with dandruff." ], "set_id": "23b04364-48e8-4718-b3e1-f3eb6107ca54", "id": "11acc108-f5f5-5d99-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient Pyrithione zinc 1%" ] }, { "effective_time": "20100930", "inactive_ingredient": [ "Inactive Ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "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 facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use • if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. 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? Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "ASPIRIN LOW DOSE Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 IRON METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink a full glass of water with each dose do not exceed recommended dosage adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use 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." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION store at 20° to 25°C (68° to 77°F)" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs" ], "do_not_use": [ "Do not use • if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Package Label Blister of 30 Tablets Blister of 30 Tablets" ], "indications_and_usage": [ "USES for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product" ], "set_id": "24262441-3582-42b8-853e-6393bef275d1", "id": "24262441-3582-42b8-853e-6393bef275d1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if taking a prescription drug for diabetes, gout or arthritis" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20101123", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), glycerin, PEG-8, hydrated silica, silica, PEG/PPG-116/66 copolymer, calcium sulfate, sodium lauryl sulfate, flavor, dipotassium phosphate, sodium carbonate, sodium saccharin, cellulose gum, titanium dioxide" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "Age Defying Fluoride and Liquid Calcium Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SILICON DIOXIDE POLOXALENE CALCIUM SULFATE SODIUM LAURYL SULFATE PHOSPHATE ION SODIUM CARBONATE SACCHARIN SODIUM DIHYDRATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions supervise children as necessary until capable of using without supervision do not swallow adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste Protects and Rebuilds Enamel Mint AGE DEFYING NET WT. 4.3 OZ. (121g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "246bc89a-43f0-484e-8b31-4757b683ca17", "id": "27a40ee2-4f97-4190-8862-1be063e3a180", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20131112", "inactive_ingredient": [ "INACTIVE INGREDIENTS croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS? call 1-800-406-7984 Contains No Aspirin Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880" ], "spl_product_data_elements": [ "Arthritis Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES STARCH, CORN PROPYLENE GLYCOL SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE cor116 Capsule Shaped" ], "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 (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date (Applicable only for Bottle Carton) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 33261-0665-50 EASY TO OPEN BOTTLE Use only as directed. See New Warnings Information Lasts up to 8 hours Arthritis Pain Relief Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 50 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) † Compare to the active ingredient of Tylenol ® Arthritis Pain † This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., The owner of the registered trademark Tylenol ® is the Tylenol Company. Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 IMAGE LABEL" ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache headache toothache the common cold premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "24837136-b72b-4c93-9b4e-7b6d1c6d18cc", "id": "8fa5d478-4b57-48f2-80ef-746f8f8953b6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg" ], "dosage_and_administration_table": [ "
adults take 2 caplets every 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age ask a doctor
" ] }, { "effective_time": "20100326", "inactive_ingredient": [ "Sorbitol , Water, Hydrated Silica, PEG-32, Sodium Lauryl Sulfate, SD-Alcohol 38B, Flavor, Cellulose Gum, Sodium Saccharin, Red33, Red40" ], "warnings": [ "KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. IF MORE THAN USED FOR BRUSHING, IS ACCIDENTALLY SWALLOWED. GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "questions": [ "Questions or Comments ?: Call 1-800-786-5135 Monday -Friday 9am-5pmET" ], "spl_product_data_elements": [ "Close Up Anticavity Toothpaste Anticavity Toothpaste Sodium Fluoride Fluoride Ion" ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "Image of Tube Label" ], "set_id": "24a78be9-8d6a-492b-b340-682f4be94822", "id": "dec0bb47-280a-4c76-9aeb-fb3164af043d", "active_ingredient": [ "Drug Facts: Sodium Fluoride: 0.24% Purpose: Anticavity Toothpaste" ] }, { "effective_time": "20091201", "inactive_ingredient": [ "Inactive ingredients Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide DEA, Fragrance (Parfum), DMDM Hydantoin, Citric acid, Disodium EDTA, FD and C Yellow No. 5, FD and C Blue No. 1" ], "warnings": [ "Warnings For external use only When using this product ， avoid contact with eyes. In case of contact, flush with water Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away" ], "when_using": [ "Directions Wet hands. Apply small amount to hands. Scrub thoroughly. Rinse. For children under 6, use only under adult supervision" ], "spl_product_data_elements": [ "Pier 1 Imports Coconut Breeze Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash TRICLOSAN TRICLOSAN WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE 1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C YELLOW NO. 5 FD&C BLUE NO. 1 Coconut Breeze" ], "description": [ "Uses For hand washing to decrease bacteria on skin" ], "openfda": {}, "version": "1", "package_label_principal_display_panel": [ "label label" ], "set_id": "24da6b80-68b1-4656-9190-3d4d57151aad", "id": "646fe108-8ec7-4ac5-bfd2-bda0a442fb88", "active_ingredient": [ "Active ingredients Purpose Triclosan 0.115% Antibacterial" ] }, { "effective_time": "20090602", "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, edible ink, FD&C yellow #6, hypromellose, iron oxide black, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain 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: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? 1-800-719-9260" ], "spl_product_data_elements": [ "Sunmark aspirin low dose Aspirin ASPIRIN ASPIRIN L535" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions drink a full glass of water with each dose do not exceed recommended dosage adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use 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 you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs" ], "storage_and_handling": [ "Other information {Non-CRC Package Only} store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Bayer® 81 mg Aspirin active ingredient Aspirin Low Dose Pain Reliever (NSAID) Safety Coated 81 mg See New Warnings Information This Package for Households Without Young Children {Non-CRC package only} Aspirin Carton Aspirin Carton" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product" ], "set_id": "253e5ced-7c45-4c31-8d1c-49cbbbfcf31f", "id": "253e5ced-7c45-4c31-8d1c-49cbbbfcf31f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20090721", "inactive_ingredient": [ "Inactive ingredients Aloe Vera, Cetostearyl Alcohol, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate and White Petrolatum." ], "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 or around eyes for diaper rash Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone products. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "QUESTIONS? Call 1-800-344-7239 or write to Consumer Affairs at the address below" ], "spl_product_data_elements": [ "Caldecort Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF CETOSTEARYL ALCOHOL PROPYLENE GLYCOL WATER SODIUM LAURYL SULFATE PETROLATUM" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions use only as directed apply externally to the affected area not more than 3 to 4 times daily. children under 2 years of age: Do not use, ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749 For a description of all of our products visit us at www.insightpharma.com" ], "stop_use": [ "Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone products." ], "storage_and_handling": [ "Other Information store at room temperature 15°–25°C (59°–77°F) see box or crimp of tube for lot number and expiration date" ], "do_not_use": [ "Do not use in or around eyes for diaper rash" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 1 OZ Box Contains Moisturizing ALOE VERA Maximum Strength Without A Prescription CALDECORT ® HYDROCORTISONE 1% Anti-Itch Cream NET WT. 1 OZ (28.4g) Principle Display Panel - 1 OZ Box" ], "indications_and_usage": [ "Uses temporarily relieves itching associated with minor skin irritations and rashes due to: insect bites poison ivy, poison oak, poison sumac soaps and detergents eczema psoriasis cosmetics jewelry seborrheic dermatitis other uses of this product should be only under the advice and supervision of a doctor." ], "set_id": "258723cf-d72e-49ee-8eaf-03fc00fa4a7c", "id": "a9429796-26b5-4df8-b7fe-adb22519dd18", "active_ingredient": [ "Active ingredient Hydrocortisone USP 1%" ] } ] }