Omeprazole Delayed Release Tablets

Omeprazole Delayed Release Tablets
SPL v1
SPL
SPL Set ID 77d4f6c7-87ca-78bb-3310-2304a68f9f9b
Route
ORAL
Published
Effective Date 2017-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Ammonia Carnauba Wax Hypromellose Acetate Succinate 06081224 (3 Mm2/s) Hypromelloses Ferrosoferric Oxide Lactose Monohydrate Monoethanolamine Butyl Alcohol Polyethylene Glycol 3350 Polyvinyl Alcohol Povidone Propylene Glycol Ferric Oxide Red Sodium Stearate Sodium Starch Glycolate Type A Potato Shellac Sodium Lauryl Sulfate Sodium Stearyl Fumarate Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-04-01

Description

Omeprazole  USP, 20 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Omeprazole  USP, 20 mg

Use(s)
  • 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.
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
Active Ingredient(s)

Omeprazole  USP, 20 mg

Inactive Ingredients

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose, hypromellose acetate succinate, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulphate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide

Questions Or Comments?

call 1-888-375-3784

Distributed by:

CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made in India

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 lightheadednes
  • frequent chest pain

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

Principal Display Panel

14count Container Label:

14count Carton Label:

Stop Use and Ask 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)

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

Structured Label Content

Use(s)
  • 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.
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
Active Ingredient(s) (Active ingredient(s))

Omeprazole  USP, 20 mg

Inactive Ingredients (Inactive ingredients)

ammonia solution, ammonium hydroxide, carnauba wax, hypromellose, hypromellose acetate succinate, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulphate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide

Questions Or Comments? (Questions or comments?)

call 1-888-375-3784

Distributed by:

CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made in India

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 lightheadednes
  • frequent chest pain

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

Principal Display Panel

14count Container Label:

14count Carton Label:

Stop Use and Ask Doctor If: (Stop use and ask 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)

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

Advanced Ingredient Data


Raw Label Data

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