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

Purpose

Acid reducer Allows absorption of this omeprazole product

Description

Omeprazole 20 mg Sodium Bicarbonate 1100 mg


Medication Information

Warnings

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

Purpose

Acid reducer

Allows absorption of this omeprazole product

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

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.
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

Warnings

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

Purpose

Acid reducer

Allows absorption of this omeprazole product

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

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.
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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