Omeprazole OMEPRAZOLE AUROHEALTH LLC FDA Approved 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
Generic: OMEPRAZOLE
Mfr: AUROHEALTH LLC FDA #7 OTC
FunFoxMeds bottle
Route
ORAL
Applications
ANDA213201
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Omeprazole delayed-release capsules USP 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Inactive Ingredients
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.
Strengths
20 mg 20.6 mg
Quantities
14 capsules 14 tablet
Treats Conditions
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
Pill Appearance
Shape: capsule Color: pink Imprint: OZM;20

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0358602837051
UNII
426QFE7XLK
Packaging

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 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 Descriptions
  • 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 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

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. If pregnant or breast-feeding, ask a health professional before use.
Purpose

Purpose Acid reducer

Do Not Use

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.

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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)


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