Omeprazole And Sodium Bicarbonate Powder, For Suspension
FDA Label NDC 43598-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc., for the product Omeprazole And Sodium Bicarbonate (NDC 43598-010). 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 ingredient(s), purpose, use(s), warnings, allergy alert:, do not use if you have:, ask a doctor before use if you have:, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Drug Facts

Active ingredients

Purpose

(in each powder packet)

Omeprazole, USP 20 mg Acid reducer

Sodium Bicarbonate, USP 1,680 mg Allows absorption of this omeprazole product

Purpose

Acid reducer

Allows absorption of this omeprazole product

Use(S)

  • 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 Doctor If

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days unless directed by your doctor
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea
  • you develop a rash or joint pain

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
  • product should be taken at least 1 hour before eating in the morning
  • take every day for 14 days
  • do not take more than once a day
  • empty packet contents into a small cup containing 2 tablespoons of WATER
  • DO NOT USE WITH OTHER LIQUIDS OR FOOD
  • stir well and drink immediately
  • refill cup with water and drink
  • 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 powder packet contains: sodium 460 mg
  • read the directions and warnings before use
  • keep the carton. It contains important information
  • store between 20° to 25 °C (68° to 77°F)
  • tamper-evident: do not use if foil is open or broken
  • keep product out of high heat and humidity
  • protect product from moisture

Inactive Ingredients

mixed berries flavor, sucralose, sucrose, xanthan gum, xylitol

and

menthol plus peppermint flavor, sucralose, sucrose, xanthan gum, xylitol

Questions Or Comments?

call toll-free weekdays 8 AM to 8 PM EST Call 1-888-375-3784

Principal Display Panel

Omeprazole 20 mg /Acid Reducer

Sodium Bicarbonate 1,680 mg/Allows Absorption of this Omeprazole Product

Berrycarton (Berrycarton)

Berrycarton (Berrycarton)

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