Omeprazole Delayed-release Tablets, 20 Mg

SPL v5

SPL

SPL Set ID 51c3ef34-b7c1-419e-a784-ae82540c7a22

Route

ORAL

Published

Effective Date 2025-04-28

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Omeprazole (20 mg)

Inactive Ingredients

Anhydrous Lactose Hypromellose, Unspecified Hypromellose Acetate Succinate 12070923 (3 Mm2/s) Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Monoethanolamine Methylcellulose (1500 Mpa.s) Propylene Glycol Sodium Starch Glycolate Type A Potato Sodium Stearate Sodium Stearyl Fumarate Sodium Lauryl Sulfate Triethyl Citrate Talc Titanium Dioxide Ammonia Ferrosoferric Oxide Butyl Alcohol Shellac

Identifiers & Packaging

Pill Appearance

Imprint: 20 Shape: oval Color: brown Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2019-01-01

Description

Omeprazole USP 20 mg

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Omeprazole USP 20 mg

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

Allergy alert:

do not use if you are allergic to omeprazole

• omeprazole may cause severe skin reactions. Symptoms may include:

• skin reddening • blisters • rash

If an allergic reaction occurs, stop use and seek medical help right away.

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.

Do Not Use

if you have:

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, neck or shoulders; or lightheadedness
frequent chest pain

These may be signs of a serious condition. See your doctor.

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.

Tips of 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

Stop Use and Ask A Doctor 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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Principal Display Panel Foil

62756-377-40

Omeprazole Delayed-Release Tablet

20 mg

Acid Reducer

PUSH THROUGH

Take 1 tablet a day fo 14 days

Mfg. by: Sun Pharmaceutical Ind Ltd., India.

Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512

PGPF0520A

Principal Display Panel Label

NDC 62756-377-21

Treats Frequent Heartburn!(24 HR)

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

14 Tablets

ONE 14-DAY COURSE OF TREATMENT

May take 1 to 4 days for full effect

Active Ingredient(in Each Tablet)

Omeprazole USP 20 mg

Ask A Docotor Before Use If You Have:

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Principal Display Panel Bottle Carton

NDC 62756-377-11

Compare to Prilosec OTC ® *

Treats Frequent Heartburn! (24 HR)

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

SWALLOW - DO NOT CHEW

28 Tablets

TWO 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

Principal Display Panel Blister Carton

NDC 62756-377-96

Compare to Prilosec OTC ® *

Treats Frequent Heartburn! (24 HR)

Compare to Prilosec OTC ^{® *}

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

SWALLOW - DO NOT CHEW

28 (2 x 14) Unit-Dose Tablets

TWO 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Structured Label Content

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

Purpose

Acid reducer

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.

Do Not Use (Do not use)

if you have:

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, neck or shoulders; or lightheadedness
frequent chest pain

These may be signs of a serious condition. See your doctor.

Other 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 (Inactive ingredients)

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions Or Comments? (Questions or Comments?)

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

Tips of 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

Stop Use and Ask A Doctor If (Stop use and ask a doctor 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Principal Display Panel Foil (Principal Display Panel - Foil)

62756-377-40

Omeprazole Delayed-Release Tablet

20 mg

Acid Reducer

PUSH THROUGH

Take 1 tablet a day fo 14 days

Mfg. by: Sun Pharmaceutical Ind Ltd., India.

Dist. by: Sun Pharmaceutical Ind Inc., NJ 08512

PGPF0520A

Principal Display Panel Label (Principal Display Panel - Label)

NDC 62756-377-21

Treats Frequent Heartburn!(24 HR)

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

14 Tablets

ONE 14-DAY COURSE OF TREATMENT

May take 1 to 4 days for full effect

Active Ingredient(in Each Tablet) (Active ingredient(in each tablet))

Omeprazole USP 20 mg

Ask A Docotor Before Use If You Have: (Ask a docotor before use if you have:)

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Principal Display Panel Bottle Carton (Principal Display Panel - Bottle Carton)

NDC 62756-377-11

Principal Display Panel Blister Carton (Principal Display Panel - Blister Carton)

NDC 62756-377-96

Compare to Prilosec OTC ® *

Treats Frequent Heartburn! (24 HR)

Compare to Prilosec OTC ^{® *}

Omeprazole Delayed-release Tablets

20 mg

Acid Reducer

SWALLOW - DO NOT CHEW

28 (2 x 14) Unit-Dose Tablets

TWO 14-DAY COURSES OF TREATMENT

May take 1 to 4 days for full effect

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "OMEPRAZOLE", "unii": "KG60484QX9", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)", "unii": "36BGF0E889", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MONOETHANOLAMINE", "unii": "5KV86114PT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLCELLULOSE (1500 MPA.S)", "unii": "P0NTE48364", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARATE", "unii": "QU7E2XA9TG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STEARYL FUMARATE", "unii": "7CV7WJK4UI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHYL CITRATE", "unii": "8Z96QXD6UM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ALCOHOL", "unii": "8PJ61P6TS3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Acid reducer", "Warnings": "Allergy alert: do not use if you are allergic to omeprazole • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away.", "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. ", "Do not use": "if you have: 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, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition. See your doctor.", "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.", "Tips of 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", "Stop use and ask a doctor 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", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Principal Display Panel - Foil": "62756-377-40 Omeprazole Delayed-Release Tablet 20 mg Acid Reducer PUSH THROUGH Take 1 tablet a day fo 14 days Mfg. by: Sun Pharmaceutical Ind Ltd ., India. Dist. by: Sun Pharmaceutical Ind Inc ., NJ 08512 PGPF0520A", "Principal Display Panel - Label": "NDC 62756-377-21 Treats Frequent Heartburn! (24 HR) Omeprazole Delayed-release Tablets 20 mg Acid Reducer 14 Tablets ONE 14-DAY COURSE OF TREATMENT May take 1 to 4 days for full effect", "Active ingredient(in each tablet)": "Omeprazole USP 20 mg", "Ask a docotor before use if you have:": "had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain", "Principal Display Panel - Bottle Carton": "NDC 62756-377-11 Compare to Prilosec OTC ® * Treats Frequent Heartburn ! (24 HR) Omeprazole Delayed-release Tablets 20 mg Acid Reducer SWALLOW - DO NOT CHEW 28 Tablets TWO 14-DAY COURSES OF TREATMENT May take 1 to 4 days for full effect", "Principal Display Panel - Blister Carton": "NDC 62756-377-96 Compare to Prilosec OTC ® * Treats Frequent Heartburn! (24 HR) Compare to Prilosec OTC ® * Omeprazole Delayed-release Tablets 20 mg Acid Reducer SWALLOW - DO NOT CHEW 28 (2 x 14) Unit-Dose Tablets TWO 14-DAY COURSES OF TREATMENT May take 1 to 4 days for full effect", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug. Acid reducers may interact with certain prescription drugs."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:04.095015 · Updated: 2026-03-14T23:08:35.242045