Label: EQUALINE ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release
- NDC Code(s): 41163-539-01, 41163-539-02, 41163-539-03
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 1, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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Warnings
Allergy alert:
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- Do not use if you are allergic to esomeprazole.
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- Esomeprazole may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Ask a doctor before use if you have
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Ask a doctor or pharmacist before use if you are
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- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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Directions
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- adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- may take 1 to 4 days for full effect
- 14-Day Course of Treatment
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- swallow 1 capsule with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- swallow whole. Do not crush or chew capsules.
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- do not use for more than 14 days unless directed by your doctor
- Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
- Other information
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Inactive ingredients
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
EQUALINE ESOMEPRAZOLE MAGNESIUM
esomeprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-539 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MEGLUMINE (UNII: 6HG8UB2MUY) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (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:41163-539-01 1 in 1 CARTON 09/25/2017 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41163-539-02 2 in 1 CARTON 03/06/2018 03/01/2021 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41163-539-03 3 in 1 CARTON 02/28/2018 03/01/2021 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 09/25/2017 Labeler - United Natural Foods, Inc. dba UNFI (943556183)