Omeprazole

Set ID
1d500e2d-395b-437e-a95c-3922a71a0956
Manufacturer
Living Better Brands LLC | Sun Pharmaceutical Industries Limited
Effective date
2024-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:09

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

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 Blister Pack Carton

COMPARE TO Prilosec OTC ® * NDC 21130-991-14 Signature SELECT ® OMEPRAZOLE 24 HR | TREATS FREQUENT HEARTBURN Delayed-Release Tablets 20 mg Acid Reducer SWALLOW-DO NOT CHEW Actual Size 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect

NDC Codes

Ingredients

NameUNIIKind
OMEPRAZOLEKG60484QX9ACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S)36BGF0E889IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
2-AMINOETHANOL5KV86114PTIACT
METHYLCELLULOSE (1500 MPA.S)P0NTE48364IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SODIUM STEARATEQU7E2XA9TGIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
SHELLAC46N107B71OIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

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 SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-800-818-4555 weekdays.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO Prilosec OTC ® * NDC 21130-991-14 Signature SELECT ® OMEPRAZOLE 24 HR | TREATS FREQUENT HEARTBURN Delayed-Release Tablets 20 mg Acid Reducer SWALLOW-DO NOT CHEW Actual Size 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc1a05a724-635a-49fa-a890-85363fd43a27.xml2024-08-15
otcomeprazole-01.jpg2024-08-15