Label: OMEPRAZOLE tablet, delayed release
- NDC Code(s): 46122-739-03, 46122-739-04, 46122-739-74
- Packager: AMERISOURCEBERGEN DRUG CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 10, 2024
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Allergy alert:
- do not use if you are allergic to omeprazole
- omeprazole may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
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 lightheadednes
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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 before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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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 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.
- 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, titanium dioxide, triethyl citrate, yellow iron oxide
- Questions or comments?
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-739 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:46122-739-74 1 in 1 CARTON 08/30/2023 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:46122-739-03 2 in 1 CARTON 08/30/2023 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:46122-739-04 3 in 1 CARTON 08/30/2023 3 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 11/06/2018 Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)
