Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release
- NDC Code(s): 71713-202-01, 71713-202-03
- Packager: Thirty Madison Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 21, 2018
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- Active ingredient(s) in each capsule
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 taking
- 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)
Stop use and ask doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
- you need to take more than 1 course of treatment every 4 months
- you get diarrhea
- you develop a rash or joint pain
If pregnant or breast-feeding, ask a health professional before use.
- 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
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
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.
- Container Label
- Carton label
INGREDIENTS AND APPEARANCE
esomeprazole magnesium capsule, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-202 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:71713-202-01 1 in 1 CARTON 05/31/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71713-202-03 3 in 1 CARTON 05/31/2019 2 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 05/31/2019 Labeler - Thirty Madison Inc (080774087)