Drug Facts

Aurohealth LLC

Dosage Form

N/A

Manufacturer

Aurohealth LLC

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

58602-837-05

Full prescribing information (for healthcare professionals)

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.

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

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Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask a doctor before use 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

Ask a doctor or pharmacist before use if…Acid reducers may interact with certain prescription drugs.

Stop use and talk to a doctor if…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…

Package labelAUROHEALTH 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 eff…

Package labelAUROHEALTH NDC 58602-837-05 See current Drug Facts *Compare to the activeingredient in Prilosec OTC® Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR OZM 20 14 Capsules One 14-…