Label: HEALTHY ACCENTS OMEPRAZOLE- omeprazole tablet, delayed release
- Packager: DZA Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each tablet)
Omeprazole 20 mgClose
- 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
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
- 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)
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
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)
- Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F) and protect from moisture
- 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 citrateClose
- Questions or comments?
- Principal Display Panel
delayed release tablets 20 mg
treats frequent heartburn!
occurring 2 or more days a week
one 14-day course of treatmentClose
- INGREDIENTS AND APPEARANCE
HEALTHY ACCENTS OMEPRAZOLE
omeprazole tablet, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-915 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) MONOETHANOLAMINE (UNII: 5KV86114PT) Product Characteristics Color BROWN Score no score Shape OVAL Size 17mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55316-915-55 3 in 1 CARTON 1 1 in 1 CARTON 1 14 in 1 BLISTER PACK 2 NDC:55316-915-74 1 in 1 CARTON 2 14 in 1 BLISTER PACK 3 NDC:55316-915-30 2 in 1 CARTON 3 1 in 1 CARTON 3 14 in 1 BLISTER PACK 4 NDC:55316-915-03 3 in 1 CARTON 4 NDC:55316-915-01 14 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022032 03/03/2008 Labeler - DZA Brands LLC (090322194)