Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 57483-225

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovus Pharmaceuticals, Inc. for the product Esomeprazole Magnesium (NDC 57483-225). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use if you have:, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.
■ Esomeprazole may cause severe skin reactions.
Symptoms may include: ■ Skin reddening ■ blisters ■ rash

If an allergic reaction occurs, stop use and seek medical help right away.

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 a prescription drug. Acid reducers may interact with certain prescription drugs.

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 and ethyl acrylate 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:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112
www.crclehealth.com

Made in India

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 20 Mg (14 Capsule Container Label)

NDC 57483-225-14
C'rcle™  Heartburn Relief
EsomepraCare®

Esomeprazole Magnesium
Delayed-Release Capsules USP
20 mg* / Acid Reducer

See new
warning
information

24
hour
Treats Frequent
Heartburn

14 CAPSULES
One 14-day course of treatment May
take 1 to 4 days for full effect


Package Label-principal Display Panel (20 mg (14 Capsule Container Label))

Package Label-principal Display Panel (20 mg (14 Capsule Container Label))




Package Label-Principal Display Panel - 20 Mg (42 Capsule Container Carton)

Compare to active ingredient of Nexium® 24 HR†                        NDC 57483-225-42
C'rcle™ 
Heartburn Relief
EsomepraCare®

Esomeprazole Magnesium
Delayed-Release Capsules USP
20 mg* / Acid Reducer

See new warning information
24
hour
Treats Frequent Heartburn

42 CAPSULES
TRIPLE PACK 3X14 count bottles inside
Three 14-day courses of treatment
May take 1 to 4 days for full effect


 

Package Label-principal Display Panel (20 mg (14 Capsule Container Carton))

Package Label-principal Display Panel (20 mg (14 Capsule Container Carton))



       

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