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Drug Facts
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
The following Structured Product Label (SPL) was submitted to the FDA by H2-pharma, Llc for the product Omeprazole (NDC 61269-720). 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, do not use if you have, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Acid reducer
If an allergic reaction occurs, stop use and seek medical help right away.
These may be signs of a serious condition. See your doctor.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
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 (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, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, red iron oxide, sucrose, talc, titanium dioxide, triethyl citrate
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NDC 61269-720-14
*Compare to the active ingredient in Prilosec OTC®
See current Drug Facts
24-Hour
Omeprazole
Delayed-Release Tablets, 20 mg
Acid Reducer
Treats FREQUENT heartburn!
May take 1 to 4 days for full effect
ACTUAL SIZE
14 Tablets (One 14-Day Course of Treatment)
H2 pharma
* Please review the disclaimer below.