Target Corporation Omeprazole Drug Facts

Target Corporation Omeprazole Drug Facts
SPL v5
SPL
SPL Set ID 8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56
Route
ORAL
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg)
Inactive Ingredients
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Ascorbic Acid Cetyl Alcohol Silicon Dioxide Crospovidone, Unspecified Ferric Oxide Red Hypromellose, Unspecified Mannitol Microcrystalline Cellulose Propylene Glycol Sodium Stearate Sodium Stearyl Fumarate Sorbitol Sucralose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 20 Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
NDA Completed Since 2018-05-09 Until 2020-08-01

Description

Omeprazole 20 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Omeprazole 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
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
  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • 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
  • do not take this medicine with alcohol
  •  
    Repeated 14-Day Course (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 before use. 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 20-25°C (68-77°F); keep product out of high heat and moisture
  • take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.
Inactive Ingredients

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions Or Comments?

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

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 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
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).

Active Ingredient (in Each Tablet)

Omeprazole 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
Package/label Principal Display Panel

Compare to Prilosec OTC®

Omeprazole

Delayed Release Orally Disintegrating Tablets 20 mg / Acid Reducer

Treats frequent heartburn!

Dissolve tabs

Melts in your mouth

dissolves without water

Strawberry Flavor

24 HR

up&up

Actual Size

42 Tablets

42 TABLETS – THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

MELTech®

Melts In Your Mouth

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
  • 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
  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • 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
  • do not take this medicine with alcohol
  •  
    Repeated 14-Day Course (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 before use. 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 20-25°C (68-77°F); keep product out of high heat and moisture
  • take the tablet immediately after opening individual blister. Do not store the tablet outside the blister pack for future use.
Inactive Ingredients (Inactive ingredients)

amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST

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 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
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).

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

Omeprazole 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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Prilosec OTC®

Omeprazole

Delayed Release Orally Disintegrating Tablets 20 mg / Acid Reducer

Treats frequent heartburn!

Dissolve tabs

Melts in your mouth

dissolves without water

Strawberry Flavor

24 HR

up&up

Actual Size

42 Tablets

42 TABLETS – THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

MELTech®

Melts In Your Mouth

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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