Active Ingredients And Purpose
Active ingredient(in each tablet)
Omeprazole USP 20 mg
Purpose
Acid reducer
Omeprazole Delayed-release Tablets, 20 mg
- Manufacturer
- Redpharm Drug
- Effective date
- 2025-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:05
Key Label Information
Uses
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
Warnings
Directions And Dosage
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 Label Information
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.
Questions or Comments?
Call toll free 1-800-818-4555 weekdays.
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
† Compare To Prilosec OTC ® NDC 51660-029-27 Omeprazole Delayed-release Tablets 20 mg / Acid Reducer SWALLOW- DO NOT CHEW Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-day courses of treatment May take 1 to 4 days for full effect ohm ®
NDC Codes
Ingredients
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient(in each tablet)
Omeprazole USP 20 mg
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
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.
Questions or Comments?
Call toll free 1-800-818-4555 weekdays.
SPL UNCLASSIFIED SECTION
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
† Compare To Prilosec OTC ® NDC 51660-029-27 Omeprazole Delayed-release Tablets 20 mg / Acid Reducer SWALLOW- DO NOT CHEW Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-day courses of treatment May take 1 to 4 days for full effect ohm ®
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/44f59d88-d401-950b-e063-6294a90a2a50/44f5aafa-b7be-b398-e063-6394a90ab9f3.xml
- XML SHA-256
- 2c066f6ffa80762e87cb9c010f39a3b8f9b6e783230d3a1c69be53fe446f9326
- XML bytes
- 32707
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 44f5aafa-b7be-b398-e063-6394a90ab9f3.xml | 2025-12-03 |
| otc | omeprazole-01.jpg | 2025-12-03 |