Prilosec Otc ®

Prilosec Otc ®
SPL v16
SPL
SPL Set ID 77ed80a2-a482-4838-ac55-4865b5c31d9f
Route
ORAL
Published
Effective Date 2023-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20.6 mg)
Inactive Ingredients
Starch, Rice Povidone K60 Hydroxypropyl Cellulose Hypromelloses Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Paraffin Polyethylene Glycol 6000 Polysorbate 80 Sodium Stearyl Fumarate Sucrose Talc Glyceryl Monostearate Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: pink Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2003-07-14

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 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
    • 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.
Questions?

1-800-289-9181

Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F) and protect from moisture
Inactive Ingredients

glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

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 delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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 14 Tablet Carton

See current Drug Facts

NDC 37000-455-03

Treats FREQUENT Heartburn! 24 HR

Prilosec OTC ®

omeprazole delayed-release tablets

20 mg / acid reducer

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

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
Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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
    • 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.
Questions?

1-800-289-9181

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) and protect from moisture
Inactive Ingredients (Inactive ingredients)

glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate

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 delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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 14 Tablet Carton (PRINCIPAL DISPLAY PANEL - 14 Tablet Carton)

See current Drug Facts

NDC 37000-455-03

Treats FREQUENT Heartburn! 24 HR

Prilosec OTC ®

omeprazole delayed-release tablets

20 mg / acid reducer

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

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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