Active Ingredient (In Each Tablet)
Omeprazole delayed-release tablet 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Omeprazole (NDC 67091-464). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, warnings, do not use if you have:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Omeprazole delayed-release tablet 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
Acid reducer
Allergy alert:
if an allergic reaction occurs, stop use and seek medical help right away.
These may be signs of a serious condition. See your doctor.
taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, dextrose, FD&C Blue #2, FD&C Red #40, flavor, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polysorbate 80, polyvinyl alcohol, propylene glycol, sucralose, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
†Compare to the active ingredient in Prilosec® OTC
Omeprazole
Delayed-release
OMEPRAZOLE USP 20 mg ACID REDUCER
Treats Frequent heartburn
Occurring 2 or More Days a week
COATED WITH WILDBERRY FLAVOR
SWALLOW- DO NOT CHEW
Tablets
ONE 14-DAY COURSE OF TREATMENT
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
*This product is not manufactured or distributed by ASTRAZENECA PHARMACEUTICALS LP, owner of the registered trademark of PRILOSEC OTC®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE, ID 83704
* Please review the disclaimer below.