ACID REDUCER POWDER- omeprazole and sodium bicarbonate powder, for suspension

Acid Reducer Powder by

Drug Labeling and Warnings

Acid Reducer Powder by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

• 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

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
• 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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

TIPS FOR MANAGING HEARTBURN

• Do not lie flat or bend over soon after eating
• Do not eat late at night or just before bedtime
• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables
• Eat slowly and do not eat big meals
• If you are oveweight, lose weight
• If you smoke, quit smoking
• Raise the head of your bed
• Wear loose-fitting clothing around your stomach

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

INGREDIENTS AND APPEARANCE

ACID REDUCER POWDER 
omeprazole and sodium bicarbonate powder, for suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75907-237
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)	OMEPRAZOLE	20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1680 mg

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75907-237-14	14 in 1 CARTON	12/15/2024
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA217784	07/15/2024

Labeler - Dr. Reddy's Laboratories Inc., (802315887)