Omeprazole Capsule, Delayed Release
FDA Label NDC 58602-837

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Omeprazole (NDC 58602-837). 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 active ingredient (in each capsule), purpose, use, 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 taking a prescription drug., 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

Active Ingredient (In Each Capsule)

Omeprazole delayed-release capsules, USP 20 mg
(equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

Use

  • 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 omeprazole.

•   Omeprazole 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

  • for adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours

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
  • do not use for more than 14 days unless directed by your doctor
  • swallow whole. Do not chew or crush capsules.

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. Heartburn in children may sometimes be caused by a serious condition.

Other Information

  • each capsule contains: calcium 110 mg
  • read the directions and warnings before use 
  • keep the carton. It contains important information. 
  • store at 20° to 25°C (68° to 77°F) and protect from moisture
  • FDA approved dissolution test specifications differ from USP.

Inactive Ingredients

black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.



Questions?

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

Tips For Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

    • Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India
    Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 20 Mg (14 Capsules Bottle)

AUROHEALTH            
NDC 58602-837-05

See current Drug Facts

Omeprazole
Delayed-Release Capsules, USP
20 mg/Acid Reducer
Treats Frequent Heartburn!
24 HR
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 Tablet Bottle))

Package Label-principal Display Panel (20 mg (14 Tablet Bottle))


Package Label-Principal Display Panel - 20 Mg Container Carton Label

AUROHEALTH
NDC 58602-837-05

See current Drug Facts

*Compare to the active
ingredient in Prilosec OTC®

Omeprazole
Delayed-Release
Capsules, USP
20 mg/Acid Reducer
 Treats Frequent Heartburn!
24 HR

OZM 20

14 Capsules
One 14-Day Course of Treatment
May Take 1 to 4 days for full effect

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

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


* Please review the disclaimer below.