Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 19097902-a5e6-423a-8569-31c569cd3cdb

Route

ORAL

Published

Effective Date 2024-02-19

Document Type 34390-5 Human OTC Drug Label

Composition & Product

Active Ingredients

Omeprazole (20 mg)

Inactive Ingredients

Ferrosoferric Oxide Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Gelatin, Unspecified Hypromellose 2910 (3 Mpa.s) Ferric Oxide Red Polyethylene Glycol 3350 Magnesium Oxide Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) Microcrystalline Cellulose 102 Glyceryl Mono And Dipalmitostearate Polysorbate 80 Polyvinyl Alcohol, Unspecified Potassium Hydroxide Shellac Sodium Lauryl Sulfate Dextrose, Unspecified Form Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance

Imprint: OZM;20 Shape: capsule Color: pink Color: white Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2023-04-28

Description

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

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

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

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

Questions?

Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Other Information

each capsule contains: calcium 110 mg
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
FDA approved dissolution test specifications differ from USP.

Inactive Ingredients

black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.

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.

14 Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
do not use for more than 14 days unless directed by your doctor
swallow whole. Do not chew or crush capsules.

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

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

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)

Active Ingredient (in Each Capsule)

Omeprazole delayed-release capsules, USP 20 mg

(equivalent to 20.6 mg omeprazole magnesium USP)

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.

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

Acid reducers may interact with certain prescription drugs.

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

AUROHEALTH

NDC 58602-837-05

See current Drug Facts

Omeprazole

Delayed-Release Capsules, USP

20 mg/Acid Reducer

Treats Frequent Heartburn!

24 HR

14 Capsules

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

AUROHEALTH

NDC 58602-837-05

See current Drug Facts

*Compare to the active

ingredient in Prilosec OTC^®

Omeprazole

Delayed-Release

Capsules, USP

20 mg/Acid Reducer

Treats Frequent Heartburn!

24 HR

OZM 20

14 Capsules

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.

• 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

Questions?

Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Other Information (Other information)

each capsule contains: calcium 110 mg
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
FDA approved dissolution test specifications differ from USP.

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.

14 Day Course of Treatment (14-Day Course of Treatment)

swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
do not use for more than 14 days unless directed by your doctor
swallow whole. Do not chew or crush capsules.

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

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

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)

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Omeprazole delayed-release capsules, USP 20 mg

(equivalent to 20.6 mg omeprazole magnesium USP)

Repeated 14 Day Courses (if Needed) (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.

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)

Acid reducers may interact with certain prescription drugs.

Package Label Principal Display Panel 20 Mg (14 Capsules Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules 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. • 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", "Questions?": "Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)", "Other information": "each capsule contains: calcium 110 mg 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 FDA approved dissolution test specifications differ from USP.", "Inactive ingredients": "black iron oxide, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, hypromellose, iron oxide red, macrogol, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, mono and di-glycerides, polysorbate 80, polyvinyl alcohol-part. hydrolyzed, potassium hydroxide, shellac, sodium lauryl sulphate, sugar spheres [liquid glucose, starch (maize), sucrose], talc, titanium dioxide, triethyl citrate.", "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.", "14-Day Course of Treatment": "swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush capsules.", "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 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009", "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)", "Active ingredient (in each capsule)": "Omeprazole delayed-release capsules, USP 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)", "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.", "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": "Acid reducers may interact with certain prescription drugs.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Bottle)": "AUROHEALTH NDC 58602-837-05 See current Drug Facts Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn! 24 HR 14 Capsules 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": "AUROHEALTH NDC 58602-837-05 See current Drug Facts *Compare to the active ingredient in Prilosec OTC ® Omeprazole Delayed-Release Capsules, USP 20 mg/Acid Reducer Treats Frequent Heartburn ! 24 HR OZM 20 14 Capsules One 14-Day Course of Treatment May Take 1 to 4 days for full effect"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.372454 · Updated: 2026-03-14T23:02:32.213463