Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release
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NDC Code(s):
37000-459-01,
37000-459-02,
37000-459-03,
37000-459-04, view more37000-459-05
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 10, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
- Warnings
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DO NOT USE
Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulderpain with shortness of breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
- frequent chest pain
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
- Stop use and ask a doctor if:
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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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, crush, or suck 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
FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14 Tablet Carton
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INGREDIENTS AND APPEARANCE
PRILOSEC OTC
omeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-459 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength STARCH, RICE (UNII: 4DGK8B7I3S) POVIDONE K60 (UNII: SZR7Z3Q2YH) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C RED NO. 40 (UNII: WZB9127XOA) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICA (UNII: V8A1AW0880) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color purple Score no score Shape OVAL Size 15mm Flavor BERRY Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-459-01 1 in 1 POUCH; Type 0: Not a Combination Product 08/15/2012 2 NDC:37000-459-02 14 in 1 CARTON 08/15/2012 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:37000-459-03 2 in 1 CARTON 08/15/2012 12/01/2022 3 14 in 1 CARTON 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:37000-459-04 3 in 1 CARTON 08/15/2012 4 14 in 1 CARTON 4 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:37000-459-05 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021229 08/15/2012 Labeler - The Procter & Gamble Manufacturing Company (004238200) Registrant - AstraZeneca AB (Sweden) (876516568)