OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole and sodium bicarbonate powder, for suspension 
Dr. Reddy's Laboratories Inc.,

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Drug Facts

Active ingredient(s)

Active ingredients

(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)

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

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

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

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

Questions or comments?

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

TIPS FOR MANAGING HEARTBURN

HOW OMEPRAZOLE AND SODIUM BICARBONATE POWDER FOR ORAL SUSPENSION WORKS FOR YOUR FREQUENT HEARTBURN

Omeprazole and Sodium Bicarbonate Powder for Oral Suspension works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and Sodium Bicarbonate Powder for Oral Suspension stops acid production at the source – the acid pump that produces stomach acid. Omeprazole and Sodium Bicarbonate Powder for Oral Suspension is to be used once a day (every 24 hours), every day for 14 days.

*This product is not manufactured or distributed by Santarus, Inc. or Riley Consumer Care. Zegerid OTC® is a registered trademark of Santarus, Inc.

Distributed by:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

Made in India

Issued: 07/2023

Principal Display Panel

Omeprazole 20 mg /Acid Reducer

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

Carton

OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole and sodium bicarbonate powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75907-138
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1680 mg
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75907-138-4242 in 1 CARTON07/15/2024
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21778407/15/2024
Labeler - Dr. Reddy's Laboratories Inc., (802315887)

Revised: 7/2024
Document Id: 3ccc6e19-1da7-caa1-2b51-6946e92a1a79
Set id: ddee28fb-c871-a6d4-984f-515522b28412
Version: 1
Effective Time: 20240715
 
Dr. Reddy's Laboratories Inc.,