Esomeprazole Magnesium: Package Insert and Label Information

ESOMEPRAZOLE MAGNESIUM — esomeprazole magnesium dihydrate capsule, delayed release
Ahold U.S.A., Inc,

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Uses

  • treats frequent heartburn (occurs 2 or more days a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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 lightheadedness
  • 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 antifungal or anti-yeast medicines
  • digoxin (heart medicine)
  • diazepam (anxiety medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)

Stop use and ask a 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
  • Meets USP dissolution test 2

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions or comments?

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

DISTRIBUTED BY: FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
Product of India
Code: TS/DRUGS/22/2009
1-877-846-9949
©2019 Ahold Licensing Delhaize
Quality guaranteed or your money back.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (14 Capsule Container Label)

CAREone®
NDC 60000-109-05
ESOMEPRAZOLE MAGNESIUM
Delayed-Release Capsules USP 20 mg*
Acid Reducer
24 HR
Treats Frequent Heartburn
May take 1 to 4 days for full effect
14 Capsules
One 14-day
course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (14 Capsule Container Label)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (14 Capsule Container Carton)

CAREone®
NDC 60000-109-05
#Compare to the active ingredient
in Nexium® 24 HR
See new warning
ESOMEPRAZOLE MAGNESIUM
Delayed-Release Capsules USP 20 mg*
Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Capsules
24hr
14 Capsules
One 14-day Course of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (14 Capsule Container Carton)
(click image for full-size original)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60000-109
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM CARBONATE
MAGNESIUM OXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
GLYCERYL MONOSTEARATE
POLYSORBATE 80
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
AMMONIA
DEXTROSE, UNSPECIFIED FORM
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code I81
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60000-109-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (60000-109-05)
2 NDC:60000-109-03 3 BOTTLE in 1 CARTON contains a BOTTLE
2 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (60000-109-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209339 10/16/2017
Labeler — Ahold U.S.A., Inc, (188910863)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (60000-109), MANUFACTURE (60000-109)

Revised: 03/2021 Ahold U.S.A., Inc,

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