Label: EQUATE OMEPRAZOLE- omeprazole magnesium capsule, delayed release
- NDC Code(s): 79903-112-14, 79903-112-28, 79903-112-42
- Packager: WALMART INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 8, 2022
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- Active ingredient (in each capsule)
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
- 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 before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop 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
- you develop a rash or joint pain
- 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 capsule with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 capsule a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush capsules.
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
- Inactive ingredients
- Questions or comments?
Package/Label Principal Display Panel
THREE 14-DAY COURSES OF TREATMENT
NEW MINI CAPSULES
Treats FREQUENT Heartburn!
Compare to Prilosec OTC® active ingredient
Delayed-Release Capsules, 20mg
• 24 HR
3 Bottles Inside
Three 14-day courses of treatment
May take 1 to 4 days for full effect
INGREDIENTS AND APPEARANCE
omeprazole magnesium capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MEGLUMINE (UNII: 6HG8UB2MUY) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color WHITE, ORANGE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code 24S Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-112-14 1 in 1 CARTON 11/30/2022 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:79903-112-28 2 in 1 CARTON 11/30/2022 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:79903-112-42 3 in 1 CARTON 11/30/2022 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 ANDA216096 11/30/2022 Labeler - WALMART INC. (051957769)