Omeprazole Tablet, Delayed Release
FDA Label NDC 57483-840

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 Omeprazole (NDC 57483-840). 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 tablet), purpose, use, warnings, directions, other information, inactive ingredients, questionsor comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Spl-innovus-omeprazole-tablets (Spl Innovus Omeprazole Tablets)

Spl-innovus-omeprazole-tablets (Spl Innovus Omeprazole Tablets)

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