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SPL v6

SPL

SPL Set ID 43ea758b-6cea-44a2-b4d6-8f99211c8826

Route

ORAL

Published

Effective Date 2023-12-02

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 2018-06-06

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

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

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

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE. KANSAS CITY, KS 66106

MADE IN INDIA

Best Choice^®

100% Guaranteed

www.bestchoicebrand.com

Code TS/DRUGS/22/2009

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 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

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 (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

Ask A Doctor Or Pharmacist Before Use If You Are

warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus or mycophenolate mofetil (immune system medicines)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis medicine)

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

NDC 63941-006-05

Acid Reducer                                     Best

OMEPRAZOLE                                 Choice®

DELAYED-RELEASE TABLETS 20 mg

24 HR                                                                                    14 TABLETS

Treats Frequent Heartburn                    One 14-day course of treatment

                                                                 May take 1 to 4 days for full effect

Package Label Principal Display Panel 20 Mg Container Carton Label

NDC 63941-006-05

Best

Choice®

COMPARE TO THE ACTIVE

INGREDIENT IN PRILOSEC OTC^®*

Acid Reducer

OMEPRAZOLE

DELAYED-RELEASE

TABLETS 20 mg

24 HR

Treats FREQUENTS Heartburn

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

Purpose

Acid reducer

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.

Questions?

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)

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

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 (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

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

warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus or mycophenolate mofetil (immune system medicines)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis medicine)

Package Label Principal Display Panel 20 Mg (14 Tablet Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle))

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

Advanced Ingredient Data

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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", "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 PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO. 5000 KANSAS AVE. KANSAS CITY, KS 66106 MADE IN INDIA Best Choice ® 100% Guaranteed www.bestchoicebrand.com Code TS/DRUGS/22/2009", "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 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", "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 (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", "Ask a doctor or pharmacist before use if you are": "warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus or mycophenolate mofetil (immune system medicines) prescription antiretrovirals (medicines for HIV infection) methotrexate (arthritis medicine)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)": "NDC 63941-006-05 Acid Reducer Best OMEPRAZOLE Choice® DELAYED-RELEASE TABLETS 20 mg 24 HR 14 TABLETS Treats Frequent Heartburn One 14-day course of treatment May take 1 to 4 days for full effect ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label": "NDC 63941-006-05 Best Choice® COMPARE TO THE ACTIVE INGREDIENT IN PRILOSEC OTC ®* Acid Reducer OMEPRAZOLE DELAYED-RELEASE TABLETS 20 mg 24 HR Treats FREQUENTS Heartburn 14 TABLETS One 14-day course of treatment May take 1 to 4 days for full effect"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:25.826470 · Updated: 2026-03-14T23:01:59.101977