Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b1ba65d1-8f68-4bae-bb9d-776bba348346
Route
ORAL
Published
Effective Date 2022-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20.6 mg)
Inactive Ingredients
Ferrosoferric Oxide Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose 2208 (100 Mpa.s) Magnesium Carbonate Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Potassium Hydroxide Propylene Glycol Shellac Sodium Stearyl Fumarate Talc Titanium Dioxide Triethyl Citrate Starch, Corn Sucrose Fd&c Blue No. 1 Fd&c Red No. 40 Polyethylene Glycol 6000

Identifiers & Packaging

Pill Appearance
Imprint: RG49 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2020-08-05

Description

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

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

*Omeprazole delayed-release capsule 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

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

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.

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).

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 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.

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 toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984

Active Ingredient

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

Inactive Ingredients

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and diglycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Other Safety Information

■ read the directions and warnings before use

■ keep the carton. It contains important information.

■ Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

Principal Display Panel 42 Capsule Bottle Carton

NDC 11822-0061-4

TREATS FREQUENT HEARTBURN

Compare to the active ingredient of Prilosec OTC®†

OMEPRAZOLE

Delayed-release Capsules 20 mg*

ACID REDUCER

Mini Cap 40% Smaller Capsule

24 HR

ACTUAL SIZE

42

CAPSULES

THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

TRIPLE PACK 3 X 14 COUNT BOTTLE INSIDE


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

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

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.

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).

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 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.

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 toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984

Active Ingredient (Active ingredient)

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

Inactive Ingredients

FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and diglycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

Other Safety Information

■ read the directions and warnings before use

■ keep the carton. It contains important information.

■ Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

Principal Display Panel 42 Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton)

NDC 11822-0061-4

TREATS FREQUENT HEARTBURN

Compare to the active ingredient of Prilosec OTC®†

OMEPRAZOLE

Delayed-release Capsules 20 mg*

ACID REDUCER

Mini Cap 40% Smaller Capsule

24 HR

ACTUAL SIZE

42

CAPSULES

THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

TRIPLE PACK 3 X 14 COUNT BOTTLE INSIDE


Advanced Ingredient Data


Raw Label Data

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