Label: OMEPRAZOLE- omeprazole magnesium tablet, delayed release
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NDC Code(s):
59726-297-14,
59726-297-28,
59726-297-42,
59726-737-14, view more59726-737-28, 59726-737-42
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 20, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Use
- Warnings
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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.
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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 everyday 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.
Repeated 14-Day Courses (if needed)
- 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, 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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Tips for Managing Heartburn
- Do not lie flat or bend over after eating
- Do not wear tight-fitting clothing around the stomach
- Do not eat before bedtime
- Raise the head of your bed
- Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
- Eat slowly and avoid big meals
- If overweight, lose weight
- Quit smoking
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL, PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-297 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 ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) FERRIC OXIDE RED (UNII: 1K09F3G675) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color red Score no score Shape OVAL (capsule-shaped) Size 13mm Flavor Imprint Code OM;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-297-14 1 in 1 CARTON 06/02/2020 12/31/2025 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59726-297-28 2 in 1 CARTON 06/02/2020 12/31/2025 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59726-297-42 3 in 1 CARTON 06/02/2020 12/31/2025 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206582 06/02/2020 12/31/2025 OMEPRAZOLE
omeprazole magnesium tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-737 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 ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 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) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) DEXTROSE (UNII: IY9XDZ35W2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIACETIN (UNII: XHX3C3X673) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color purple Score no score Shape OVAL Size 13mm Flavor BERRY Imprint Code OM;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-737-14 1 in 1 CARTON 06/02/2020 12/31/2025 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59726-737-28 2 in 1 CARTON 06/02/2020 12/31/2025 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59726-737-42 3 in 1 CARTON 06/02/2020 12/31/2025 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206582 06/02/2020 12/31/2025 Labeler - P & L Development, LLC (800014821)