Label: PRILOSEC OTC- omeprazole magnesium tablet, delayed release
- NDC Code(s): 84126-301-14, 84126-301-42
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 10, 2025
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 shoulder pain 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
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
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 42 Tablet Carton
NEW FORMULA
SAME ACTIVE INGREDIENT.
SEE CURRENT DRUG FACTS.
NDC 84126-301-42
Treats FREQUENT Heartburn! 24 HR
Prilosec OTC ®
omeprazole delayed-release tablets20 mg / acid reducer
SWALLOW - DO NOT CHEW
Three 14-day courses of treatment
May take 1 to 4 days for full effect.
WILDBERRY Coated Tablet42 TABLETS

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INGREDIENTS AND APPEARANCE
PRILOSEC OTC
omeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84126-301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20.6 mg Inactive Ingredients Ingredient Name Strength ACETYL TRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POLYETHYLENE GLYCOL 8000000 (UNII: 8EIY1IHX76) Product Characteristics Color purple Score score with uneven pieces Shape OVAL Size 13mm Flavor BERRY Imprint Code 24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84126-301-14 1 in 1 CARTON 06/03/2025 1 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:84126-301-42 3 in 1 CARTON 06/03/2025 2 14 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206582 06/03/2025 Labeler - The Procter & Gamble Manufacturing Company (004238200) Registrant - The Procter & Gamble Manufacturing Company (004238200)
