Perrigo Omeprazole And Sodium Bicarbonate Drug Facts

Perrigo Omeprazole And Sodium Bicarbonate Drug Facts
SPL v3
SPL
SPL Set ID bcf32242-de17-4da1-b707-4ce26262eb78
Route
ORAL
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg) Bicarbonate Ion (1100 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Blue No. 2 Fd&c Red No. 40 Gelatin, Unspecified Polysorbate 80 Sodium Lauryl Sulfate Sodium Stearyl Fumarate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 732 Shape: capsule Color: white Size: 23 mm Score: 1
Marketing Status
ANDA Active Since 2017-06-19

Description

Omeprazole 20 mg Sodium Bicarbonate 1100 mg

Purpose

Acid reducer Allows absorption of this omeprazole product


Medication Information

Purpose

Acid reducer

Allows absorption of this omeprazole product

Description

Omeprazole 20 mg Sodium Bicarbonate 1100 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

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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

  • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
  • take every day for 14 days
  • do not take more than 1 capsule a day
  • do not chew or crush the capsule
  • do not open capsule and sprinkle on food
  • do not use for more than 14 days unless directed by your doctor

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.
Other Information
  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use
  • store at 20-25oC (68-77oF)
  • tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
  • keep product out of high heat and humidity
  • protect product from moisture
Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions Or Comments?

1-800-719-9260

Do Not Use If You Have:
  • trouble or pain swallowing food
  • vomiting with blood
  • bloody or black stools

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).

Ask A Doctor Before Use If You Have
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • 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
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • a sodium-restricted diet
Active Ingredients (in Each Capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

Package/label Principal Display Panel

Treats Frequent Heartburn

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

Acid Reducer

Allows Absorption of this Omeprazole Product

Compare to active ingredients of Zegerid OTC®

100% SATISFACTION GUARANTEED

42 Capsules

Three 14-Day Courses of Treatment

Package Contains 3 Bottles

Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)
  • any other prescription drugs. Sodium bicarbonate 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

Allows absorption of this omeprazole product

Warnings

Allergy alert: Do not use if you are allergic to omeprazole

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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

  • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
  • take every day for 14 days
  • do not take more than 1 capsule a day
  • do not chew or crush the capsule
  • do not open capsule and sprinkle on food
  • do not use for more than 14 days unless directed by your doctor

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.
Other Information (Other information)
  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use
  • store at 20-25oC (68-77oF)
  • tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
  • keep product out of high heat and humidity
  • protect product from moisture
Inactive Ingredients (Inactive ingredients)

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Do Not Use If You Have: (Do not use if you have:)
  • trouble or pain swallowing food
  • vomiting with blood
  • bloody or black stools

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).

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.
  • 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
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • a sodium-restricted diet
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

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

Treats Frequent Heartburn

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

Acid Reducer

Allows Absorption of this Omeprazole Product

Compare to active ingredients of Zegerid OTC®

100% SATISFACTION GUARANTEED

42 Capsules

Three 14-Day Courses of Treatment

Package Contains 3 Bottles

Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)
  • any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs.

Advanced Ingredient Data


Raw Label Data

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