Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7535a309-1a67-4f50-911b-7cf570322931
Route
ORAL
Published
Effective Date 2024-10-30
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 Mpa.s) Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate 2-aminoethanol 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 2020-08-10

Description

Omeprazole USP 20 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Omeprazole USP 20 mg

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

Safety Feature - Do not use if printed seal under cap is broken or missing.

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
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.

Questions

Call toll free 1-800-818-4555 weekdays.

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 include:
    • skin reddening
    • blisters
    • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient

Omeprazole USP 20 mg

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.

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
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 Tablet Bottle Carton

Compare to Prilosec OTC®

NDC 57483-840-42

Crcle

Heartburn

Relief

OmepraCareDR™

Omeprazole

Delayed-release Tablets

20 mg / Acid Reducer

24

hour

Treats FREQUENT Heartburn!

SWALLOW – DO NOT CHEW

42 TABLETS

Three 14-Day courses of treatment

May take 1 to 4 days for full effect

TRIPLE PACK 3X14 count bottles 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

Section 42229-5 (42229-5)

Safety Feature - Do not use if printed seal under cap is broken or missing.

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
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

Questions

Call toll free 1-800-818-4555 weekdays.

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 include:
    • skin reddening
    • blisters
    • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient (Active ingredient)

Omeprazole USP 20 mg

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.

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
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 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton)

Compare to Prilosec OTC®

NDC 57483-840-42

Crcle

Heartburn

Relief

OmepraCareDR™

Omeprazole

Delayed-release Tablets

20 mg / Acid Reducer

24

hour

Treats FREQUENT Heartburn!

SWALLOW – DO NOT CHEW

42 TABLETS

Three 14-Day courses of treatment

May take 1 to 4 days for full effect

TRIPLE PACK 3X14 count bottles inside


Advanced Ingredient Data


Raw Label Data

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