Omeprazole And Sodium Bicarbonate Capsule
FDA Label NDC 58602-725

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Omeprazole And Sodium Bicarbonate (NDC 58602-725). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each capsule), purpose, use, warnings, do not use if you have:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if you are taking a prescription drug., stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Capsule)

Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

Acid reducer
Allows absorption of this omeprazole product

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.

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.

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
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug.

Acid reducers may interact with certain prescription drugs.

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).

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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
  • keep product out of high heat and humidity
  • protect product from moisture

Inactive Ingredients

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions Or Comments?

Call 1-855-274-4122

Package Label-Principal Display Panel - 20 Mg/1100 Mg (14 Capsules Container Label)

AUROHEALTH
NDC 58602-725-05

CLINICALLY PROVEN TO
Treats Frequent Heartburn

Omeprazole and Sodium
Bicarbonate Capsules

•    Omeprazole 20 mg / Acid Reducer
•    Sodium Bicarbonate 1100 mg /
        Allows Absorption of this Omeprazole Product

14 Capsules
One 14-Day Course of Treatment
May Take 1 to 4 days for full effect

Package Label-principal Display Panel (20 mg/1100 mg (14 Capsules Container Label))

Package Label-principal Display Panel (20 mg/1100 mg (14 Capsules Container Label))

Package Label-Principal Display Panel - 20 Mg/1100 Mg (14 Capsules Container Carton Label)

AUROHEALTH
NDC 58602-725-05

*Compare to Zegerid OTC® Capsules
Active Ingredients

CLINICALLY PROVEN TO
Treats Frequent Heartburn

Omeprazole and Sodium
Bicarbonate Capsules

•    Omeprazole 20 mg / Acid Reducer
•    Sodium Bicarbonate 1100 mg /
        Allows Absorption of this Omeprazole Product

24 Hour

14 Capsules
One 14-Day Course of Treatment
May Take 1 to 4 days for full effect


Package Label-principal Display Panel (20 mg/1100 mg (14 Capsules Container Carton Label))

Package Label-principal Display Panel (20 mg/1100 mg (14 Capsules Container Carton Label))




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