Label: ACID REDUCER- esomeprazole magnesium capsule, delayed release
- NDC Code(s): 59726-056-14
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 14, 2021
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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
- 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
black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono-and di-glycerides, polyethylene glycol, polysorbate 80, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, sodium stearyl fumarate, sugar spheres (corn starch and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide
- Questions or comments?
Principal Display Panel
Compare to the active ingredient in Nexium® 24R†
see new warning information
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 SEAL UNDER BOTTLE CAP BROKEN OR MISSING.
KEEP 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:59726-056 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (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) CROSPOVIDONE (UNII: 2S7830E561) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code EL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-056-14 1 in 1 CARTON 12/31/2020 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 ANDA212088 12/31/2020 Labeler - P & L Development, LLC (800014821)