OMEPRAZOLE AND SODIUM BICARBONATE - omeprazole and sodium bicarbonate capsule 
Aurohealth LLC

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Drug Facts

Active ingredients (in each capsule)

Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

Acid reducer
Allows absorption of this omeprazole product

Use

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:

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.

Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if:

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

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions or comments?

Call 1-855-274-4122

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


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 Label)

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


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)



OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-725
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 BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Blue band) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code ZEG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-725-051 in 1 CARTON12/22/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-725-603 in 1 CARTON12/22/2023
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-725-572 in 1 CARTON12/22/2023
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20492312/22/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-725) , MANUFACTURE(58602-725)

Revised: 6/2024
Document Id: 88ad2e92-2228-49b2-bcee-1770fd30cb14
Set id: 88ad2e92-2228-49b2-bcee-1770fd30cb14
Version: 1
Effective Time: 20240621
 
Aurohealth LLC