Label: OMEPRAZOLE AND SODIUM BICARBONATE capsule
- NDC Code(s): 58602-725-05, 58602-725-57, 58602-725-60
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purpose
- Use
- Warnings
-
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:
- Ask a doctor or pharmacist before use if you are taking a prescription drug.
- Stop use and ask a doctor if:
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- 14-Day Course of Treatment
- Repeated 14-Day Courses (if needed)
-
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
- Questions or comments?
-
How Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg
Works For Your Frequent Heartburn
Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and Sodium Bicarbonate Capsules stops acid production at the source - the acid pump that produces stomach acid. Omeprazole and Sodium Bicarbonate Capsules is to be used once a day (every 24 hours), every day for 14 days.
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 overweight, lose weight
- If you smoke, quit smoking
- Raise the head of your bed
- Wear loose-fitting clothing around your stomach
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009 -
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 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
-
INGREDIENTS AND APPEARANCE
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-725 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 1100 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (Blue band) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code ZEG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-725-05 1 in 1 CARTON 12/22/2023 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-725-60 3 in 1 CARTON 12/22/2023 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-725-57 2 in 1 CARTON 12/22/2023 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204923 12/22/2023 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-725) , MANUFACTURE(58602-725)