Other
Drug Facts
Dist. by Procter & Gamble, Cincinnati, OH 45202
Product of Sweden
Relabeling "Additional Bar Code Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Prilosec Otc (NDC 54868-5309). 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 other, active ingredient (in each tablet), purpose, use, allergy alert, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by Procter & Gamble, Cincinnati, OH 45202
Product of Sweden
Relabeling "Additional Bar Code Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Omeprazole magnesium delayed-release tablet 20.6 mg (equivalent to 20 mg omeprazole).
Acid reducer
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
Ask a doctor or pharmacist before use if you are taking
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
1-800-289-9181
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