Label: OMEPRAZOLE AND SODIUM BICARBONATE powder, for suspension
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NDC Code(s):
43598-010-01,
43598-010-14,
43598-010-28,
43598-010-42, view more43598-307-01, 43598-307-14, 43598-307-28, 43598-307-42
- Packager: Dr. Reddy's Laboratories Inc.,
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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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.
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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.
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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
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate powder, for suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-010 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:43598-010-01 1 in 1 CARTON 07/15/2024 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:43598-010-14 14 in 1 CARTON 07/15/2024 2 1 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:43598-010-28 28 in 1 CARTON 07/15/2024 3 1 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:43598-010-42 42 in 1 CARTON 07/15/2024 4 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 OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate powder, for suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-307 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 MINT, PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43598-307-01 1 in 1 CARTON 07/15/2024 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:43598-307-14 14 in 1 CARTON 07/15/2024 2 1 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:43598-307-28 28 in 1 CARTON 07/15/2024 3 1 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:43598-307-42 42 in 1 CARTON 07/15/2024 4 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) Establishment Name Address ID/FEI Business Operations Dr. Reddy's Laboratories Limited-PU-1 860037244 analysis(43598-010, 43598-307) , manufacture(43598-010, 43598-307) , pack(43598-010, 43598-307) Establishment Name Address ID/FEI Business Operations Quality Packaging Specialists International, LLC 825078165 pack(43598-010, 43598-307)
