Omeprazole Delayed-release Tablets, 20 Mg

Omeprazole Delayed-release Tablets, 20 Mg
SPL v1
SPL
SPL Set ID 56380ccc-6fc2-4e1b-bd87-da24c9aa31cd
Route
ORAL
Published
Effective Date 2023-08-14
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 2023-08-11

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

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).

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.

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.
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.

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.

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.

Questions Or Comments?

Call 833-358-6431 M - F, 9AM - 7PM EST

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
Active Ingredient(in Each Tablet)

Omeprazole USP 20 mg

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
Principal Display Panel 20 Mg Blister Pack Carton

NDC 70677-1098-1

*COMPARE TO PRILOSEC OTC®

Foster & Thrive™

Omeprazole

Delayed-Release Tablets

20 mg / ACID REDUCER

SWALLOW- DO NOT CHEW

24 HR

Treats FREQUENT Heartburn!

One 14-day course of treatment

May take 1 to 4 days for full effect

SEE NEW WARNING INFORMATION

ACTUAL SIZE

14 TABLETS


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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

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

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.
Allergy Alert (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.

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)

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.

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.

Questions Or Comments? (Questions or Comments?)

Call 833-358-6431 M - F, 9AM - 7PM EST

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

Omeprazole USP 20 mg

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
Principal Display Panel 20 Mg Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Carton)

NDC 70677-1098-1

*COMPARE TO PRILOSEC OTC®

Foster & Thrive™

Omeprazole

Delayed-Release Tablets

20 mg / ACID REDUCER

SWALLOW- DO NOT CHEW

24 HR

Treats FREQUENT Heartburn!

One 14-day course of treatment

May take 1 to 4 days for full effect

SEE NEW WARNING INFORMATION

ACTUAL SIZE

14 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)