Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-5309-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 37000-455
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 20, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
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 taking
- 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)
- had heartburn over 3 months.
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Directions
- 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 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- swallow whole. Do not chew or crush tablets.
- 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
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Inactive ingredients
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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRILOSEC OTC
omeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5309(NDC:37000-455) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength omeprazole magnesium (UNII: 426QFE7XLK) (omeprazole - UNII:KG60484QX9) omeprazole magnesium 20.6 mg Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PARAFFIN (UNII: I9O0E3H2ZE) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color PINK Score no score Shape OVAL Size 15mm Flavor Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5309-0 3 in 1 CARTON 1 1 in 1 CARTON 1 14 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021229 05/23/2005 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack