FDA Label for Omeprazole
View Indications, Usage & Precautions
Omeprazole Product Label
The following document was submitted to the FDA by the labeler of this product Innovus Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(In Each Tablet)
Omeprazole USP 20 mg
Purpose
Acid reducer
Use
■ treats frequent heartburn (occurs 2 or moredays 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.
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 tablet with a glass of water before eating in the morning
■ take every day for 14 days
■ do not take more than 1 tablet a day
■ do not use for more than 14 days unless directed by your doctor
■ swallow whole. Do not chew or crush tablets.
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
• 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
Inactive Ingredients
anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.
Questionsor Comments?
Call toll free 1-800-818-4555 weekdays.
Package/Label Principal Display Panel
NDC 57483-840-42
Compare To Prilosec OTC®
Treats FREQUENT Heartburn!
OmepraCareDR™
Omeprazole
Delayed-release Tablets 20 mg
Acid Reducer
SWALLOW-DO NOT CHEW
24HR
42 TABLETS
Three 14-DAY courses of treatment
May take 1 to 4 days for full effect
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