Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release
- NDC Code(s): 59726-912-14
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
Updated March 3, 2020
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- Drug Facts
- Active ingredient (in each capsule)
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 taking
- warfarin, clopidogrel or cilostazol (blood-thinning medicines)
- prescription antifungal or anti-yeast medicines
- digoxin (heart medicine)
- diazepam (anxiety medicine)
- tacrolimus or mycophenolate mofetil (immune system medicines)
- prescription antiretrovirals (medicines for HIV infection)
- methotrexate (arthritis medicine)
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- may take 1 to 4 days for full effect
14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 capsule a day
• swallow whole. Do not crush or chew capsules.
• do not use for more than 14 days unless directed by your doctor
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 before use. Heartburn in children may sometimes be caused by a serious condition.
- Other information
gelatin, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion type C, mono-and di-glycerides, polysorbate 80, sodium lauryl sulfate, sugar spheres (contain sucrose, corn starch and purified water), talc, titanium dioxide, triethyl citrate.
Each capsule is imprinted with blue pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, FD&C Blue No 2 aluminum lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and having two parallel bands which contains FD&C Blue No 2 aluminum lake, gelatin and polysorbate 80
- Questions or comments?
Principal Display Panel
**Compare to the active ingredient in Nexium® 24R
USP, 20 mg*
treats frequent heartburn
may take 1 to 4 days for full effect
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP OR BAND AROUND THE CENTER OF EACH CAPSULE IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
200 Hicks Street
Westbury, NY 11590
- Package label
INGREDIENTS AND APPEARANCE
esomeprazole magnesium capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-912 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code AMNEAL1050 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-912-14 1 in 1 CARTON 01/31/2020 1 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 ANDA209716 01/31/2020 Labeler - P & L Development, LLC (800014821)