Label: ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release
- NDC Code(s): 0363-1898-01, 0363-1898-02, 0363-1898-03
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 8, 2019
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- Official Label (Printer Friendly)
- 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
- 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 4-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
FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate
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INGREDIENTS AND APPEARANCE
esomeprazole capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1898 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESOMEPRAZOLE (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FERRIC OXIDE RED (UNII: 1K09F3G675) GELATIN (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MEGLUMINE (UNII: 6HG8UB2MUY) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color BLUE (opaque) Score no score Shape CAPSULE (oblong) Size 14mm Flavor Imprint Code L898 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1898-01 1 in 1 CARTON 09/22/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-1898-02 2 in 1 CARTON 09/22/2017 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-1898-03 3 in 1 CARTON 09/22/2017 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 ANDA207193 09/22/2017 Labeler - Walgreen Company (008965063)