Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release
- NDC Code(s): 69842-277-14, 69842-277-15, 69842-277-28, 69842-277-42
- Packager: CVS Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 43598-407
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s) in each capsule
- Purpose
- Uses
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WARNINGS
Allergy alert: Do not use if you are allergic to esomeprazole
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 lightheadness frequent chest pain. These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
had heartburn over 3 months. This may be a sign of a more serious condition
.frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
Ask a doctor or pharmacist before use if you are
warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription ant fungal or anti-yeast medicines
digoxin (heart medicine)
diazepam (anxiety medicine)
tacrolimus or mycophenolate mofetil (immune system medicine)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis medicine)
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Directions
- 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
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Inactive ingredients
acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide
- Questions or comments
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SPL UNCLASSIFIED SECTION
Tips for Managing Heartburn
- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
- Eat slowly and do not eat big meals.
- Do not eat late at night or just before bedtime.
- Do not lie flat or bend over soon after eating.
- Raise the head of your bed.
- Wear loose-fitting clothing around your stomach.
- If you are overweight, lose weight.
- If you smoke, quit smoking.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-277(NDC:43598-407) 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 acetyltributyl citrate (UNII: 0ZBX0N59RZ) Dibutyl Sebacate (UNII: 4W5IH7FLNY) Ferrosoferric Oxide (UNII: XM0M87F357) Gelatin (UNII: 2G86QN327L) Glyceryl Monostearate (UNII: 230OU9XXE4) Hypromelloses (UNII: 3NXW29V3WO) Magnesium Oxide (UNII: 3A3U0GI71G) Magnesium Stearate (UNII: 70097M6I30) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J) Poloxamer 188 (UNII: LQA7B6G8JG) Polysorbate 80 (UNII: 6OZP39ZG8H) Povidone K30 (UNII: U725QWY32X) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Potassium Hydroxide (UNII: WZH3C48M4T) Shellac (UNII: 46N107B71O) Sucrose (UNII: C151H8M554) Fd&C Blue No. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE (light blue cap) , BLUE (dark blue body) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code RDY;327 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-277-14 1 in 1 CARTON 01/02/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69842-277-28 2 in 1 CARTON 01/02/2019 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69842-277-42 3 in 1 CARTON 01/02/2019 3 14 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69842-277-15 1 in 1 CARTON 05/20/2019 4 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 ANDA207673 01/02/2019 Labeler - CVS Pharmacy (062312574)
