SPL v2
SPL
SPL Set ID 10efef7c-bdf4-36cf-e063-6394a90a8c0f
Route
ORAL
Published
Effective Date 2024-05-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Crospovidone (35 .mu.m) Glyceryl Monostearate Hydroxypropyl Cellulose (90000 Wamw) Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Microcrystalline Cellulose Polyethylene Glycol 4000 Polysorbate 80 Ferric Oxide Red Silicon Dioxide Sodium Hydroxide Sodium Stearyl Fumarate Dextrose, Unspecified Form Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow Hydroxypropyl Cellulose (45000 Wamw) Hypromellose 2910 (6 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: Z;69 Shape: rectangle Color: pink Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-15
Description

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

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

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

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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug.



Acid reducers may interact with certain prescription drugs.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.
Questions?

Call 1-855-274-4122



 DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109



Made in India





Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º to 25ºC (68º to 77º F) and protect from moisture
Inactive Ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.

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.

Tips for 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
Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Ask A Doctor 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
Package Label Principal Display Panel 20 Mg (14 Tablet Bottle)

amazon

basic+care

See current Drug Facts    NDC 72288-409-05

Omeprazole

Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent                                              14 TABLETS

Heartburn!                        One 14-day course of treatment

24 HR                           May take 1 to 4 days for full effect



Package Label Principal Display Panel 20 Mg Blister Carton Label

amazon

basic+care

Acid Reducer    NDC 72288-409-01

Compare to

Prilosec OTC®

     active

ingredient*

See current Drug Facts

Omeprazole

Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!      

24 HR

actual size                            One 14-day course of treatment

                                            May take 1 to 4 days for full effect  

14 (1 x 14) TABLETS

Package Label Principal Display Panel 20 Mg Container Carton Label

amazon

basic+care

Acid Reducer

Compare to

Prilosec OTC®

    active

ingredient*

NDC 72288-409-05

See current Drug Facts

Omeprazole

Delayed-Release Tablets

20 mg

Acid Reducer

Treats Frequent Heartburn!      

24 HR



actual size

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect 

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug.



Acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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.
Questions?

Call 1-855-274-4122



 DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109



Made in India





Other Information (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20º to 25ºC (68º to 77º F) and protect from moisture
Inactive Ingredients (Inactive ingredients)

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Do Not Use If You Have: (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.

Tips for 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
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 (1-800-222-1222)  right away.

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

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Ask A Doctor Before Use If You Have: (Ask a doctor 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
Package Label Principal Display Panel 20 Mg (14 Tablet Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle))

amazon

basic+care

See current Drug Facts    NDC 72288-409-05

Omeprazole

Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent                                              14 TABLETS

Heartburn!                        One 14-day course of treatment

24 HR                           May take 1 to 4 days for full effect



Package Label Principal Display Panel 20 Mg Blister Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Blister Carton Label)

amazon

basic+care

Acid Reducer    NDC 72288-409-01

Compare to

Prilosec OTC®

     active

ingredient*

See current Drug Facts

Omeprazole

Delayed-Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!      

24 HR

actual size                            One 14-day course of treatment

                                            May take 1 to 4 days for full effect  

14 (1 x 14) TABLETS

Package Label Principal Display Panel 20 Mg Container Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label)

amazon

basic+care

Acid Reducer

Compare to

Prilosec OTC®

    active

ingredient*

NDC 72288-409-05

See current Drug Facts

Omeprazole

Delayed-Release Tablets

20 mg

Acid Reducer

Treats Frequent Heartburn!      

24 HR



actual size

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.937988 · Updated: 2026-03-14T23:02:57.214195