Gericare Pharmaceuticals Omeprazole 759

Gericare Pharmaceuticals Omeprazole 759
SPL v7
SPL
SPL Set ID 0e1f5d7c-5956-3be7-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20.6 mg)
Inactive Ingredients
Magnesium Oxide Magnesium Stearate Raw Sugar Talc Titanium Dioxide Triethyl Citrate Ferrosoferric Oxide Calcium Phosphate, Dibasic, Anhydrous Glyceryl Monostearate Hypromellose 2208 (3 Mpa.s) Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) Gelatin Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Polysorbate 80 Potassium Hydroxide Propylene Glycol Ferric Oxide Red Shellac Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: OMP20 Shape: capsule Color: pink Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2013-04-01

Description

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

*Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Uses
  • 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

  • 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 1-888-375-3784

Package Label

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

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, 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
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 Capsule)

*Omeprazole delayed-release capsules 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
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

Uses
  • 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

  • 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 1-888-375-3784

Package Label (Package label)

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)

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, 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
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 Capsule) (Active ingredient (in each capsule))

*Omeprazole delayed-release capsules 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
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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