Omeprazole

Omeprazole
SPL v2
SPL
SPL Set ID 8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573
Route
ORAL
Published
Effective Date 2020-12-03
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 (70000 Wamw) Hypromellose 2208 (100 Mpa.s) Magnesium Carbonate Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A 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: RG;49 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2020-12-01

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 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.

Allergy Alert

Do not use if you are allergic to omeprazole

Other 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
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 di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and 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.

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 Capsule)

*Omeprazole delayed-release capsule 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
Principal Display Panel 20 Mg Capsule Bottle Carton

meijer®

NDC 79481-0061-3

Compare to Prilosec OTC®

active ingredient*

omeprazole

Delayed-release Capsules | 20mg*

Treats FREQUENT Heartburn!

24 HOUR

Acid Reducer

TRIPLE PACK

3x14 COUNT BOTTLE INSIDE

42 Capsules

actual size

Three 14-Day

Courses 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
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 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.

Allergy Alert (Allergy alert)

Do not use if you are allergic to omeprazole

Other Information (Other 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
Inactive Ingredients (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 di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate

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.

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 Capsule) (Active ingredient (in each capsule))

*Omeprazole delayed-release capsule 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
Principal Display Panel 20 Mg Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Carton)

meijer®

NDC 79481-0061-3

Compare to Prilosec OTC®

active ingredient*

omeprazole

Delayed-release Capsules | 20mg*

Treats FREQUENT Heartburn!

24 HOUR

Acid Reducer

TRIPLE PACK

3x14 COUNT BOTTLE INSIDE

42 Capsules

actual size

Three 14-Day

Courses of Treatment

May take 1 to 4 days for full effect


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)