Label: OMEPRAZOLE tablet, delayed release
- NDC Code(s): 71713-201-01, 71713-201-03
- Packager: Thirty Madison Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 20, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Use
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WARNINGS SECTION
Do not use if you have
• Trouble or pain swallowing food, vomiting with blood, or bloody or black stools • 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
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
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
Ask a doctor or Pharmacist beofre using if you are
taking:
• warfarin, clopidogrel or cilostazol (blood thinning medications)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus or mycophenolate mofetil (immune system medicines)
• prescription antiretrovirals (medicines for HIV infection)
• methotrexate (arthritis medicine)
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Directions
• for 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, some people get relief of symptoms within 24 hours
• 14 day course of treatment
•swallow 1 tablet with a glass of water befre 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 days 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.
- Other Information
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Inactive Ingredients
ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanim dioxide, triethyl citrate, yellow iron oxide
- Questions or comments?
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Tips for Managing Heartburn
• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking
- Carton label
- Bottle Label
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) (UNII: 6N003M473W) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MONOETHANOLAMINE (UNII: 5KV86114PT) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) Polyethylene Glycol 3350 (UNII: G2M7P15E5P) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color BROWN (brownish pink) Score no score Shape CAPSULE Size 12mm Flavor Imprint Code O20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71713-201-01 1 in 1 CARTON 05/31/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71713-201-03 3 in 1 CARTON 05/31/2019 2 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207740 05/31/2019 Labeler - Thirty Madison Inc (080774087) Establishment Name Address ID/FEI Business Operations Dr.Reddy's Laboratories Limited (SEZ UNIT) 860037244 analysis(71713-201) , manufacture(71713-201) Establishment Name Address ID/FEI Business Operations Reed Lane Inc 001819879 repack(71713-201)