Label: DG HEALTH ESOMEPRAZOLE MAGNESIUM- esomeprazole capsule, delayed release
- NDC Code(s): 55910-640-01
- Packager: Dolgencorp Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 8, 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.
Do not use if you have:
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- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
These may be signs of a serious condition. See your doctor.
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
acacia, D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, menthol, methacrylic acid and ethyl acrylate copolymer dispersion, natural and artificial cool mint flavor, peppermint oil, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, spearmint oil, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate
- Questions or comments?
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Package/Label Principal Display Panel
DG® health
Compare to the active ingredient of Nexium® 24 HR
Esomeprazole Magnesium Delayed-Release Capsules, 20 mg
Acid Reducer
Treats Frequent Heartburn
24 HOUR
Releases a cooling sensation in mouth and throat
Cool Mint Flavor
Flavored Capsules
14 Capsules
One 14-Day Course of Treatment
Actual Capsule Size
May take 1 to 4 days for full effect
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INGREDIENTS AND APPEARANCE
DG HEALTH ESOMEPRAZOLE MAGNESIUM
esomeprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-640 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 ACACIA (UNII: 5C5403N26O) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MEGLUMINE (UNII: 6HG8UB2MUY) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) PEPPERMINT OIL (UNII: AV092KU4JH) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SPEARMINT OIL (UNII: C3M81465G5) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color BLUE (sealed with green band) Score no score Shape CAPSULE Size 14mm Flavor MINT Imprint Code L898 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-640-01 1 in 1 CARTON 05/03/2024 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 ANDA207193 05/03/2024 Labeler - Dolgencorp Inc (068331990)