OMEPRAZOLE AND SODIUM BICARBONATE - omeprazole and sodium bicarbonate capsule 
Aurolife Pharma, LLC

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Active ingredient(s)


Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose


Acid reducer
Allows absorption of this omeprazole product

Use(s)

Warnings


Allergy alert: Do not use if you are allergic to omeprazole

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

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 contract a Poison Control Center right away.

Directions


14-Day Course of Treatment


Repeated 14-Day Courses (if needed)

Other information

Inactive Ingredients


citric acid, croscarmellose sodium, FD&C Blue # 1, FD&C Red # 3, gelatin, magnesium stearate NF, pharmaceutical ink, polysorbate 80, potassium hydroxide NF, potassium sorbate, propylene glycol, Shellac,sodium lauryl sulphate, titanium dioxide,    

Questions or Comments?


Call toll-free 1-866-850-2876

How Omeprazole and Sodium Bicarbonate Capsules Work For Your Frequent Heartburn


Omeprazole and sodium bcarbonate capsules work differently form other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules stop acid production at the source-the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsules are to be used once a day (every 24 hours), every day for 14 days.

What to Expect When Using Omeprazole and Sodium Bicarbonate Capsules


Omeprazole and sodium bicarbonate capsules is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours. Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

Tips for Managing Heartburn

How are Omeprazole and Sodium Bicarbonate Capsules Sold


Omeprazole and sodium bicarbonate capsules are availble in 14, 28 and 42 count sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use of more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

PRINCIPAL DISPLAY PANEL - 14 Capsule Carton


* Compare to Zegerid OTC® Capsules                           NDC 13107-117-14
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules


                                14 Capsules
One 14-Day Course of Treatment

Aurobindo

omeprazole


PRINCIPAL DISPLAY PANEL - 28 Capsule Carton


* Compare to Zegerid OTC® Capsules                 NDC 13107-117-28
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules


                                 28 Capsules
Two 14-Day Course of Treatment

Aurobindo

omeprazole

PRINCIPAL DISPLAY PANEL - 42 Capsule Carton


* Compare to Zegerid OTC® Capsules                          NDC 13107-117-42
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules


                                   42 Capsules
Three 14-Day Course of Treatment

Aurobindo

omeprazole

OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13107-117
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: MB5IUD6JUA)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (Light Blue Opaque Cap) , WHITE (White Opaque Body) Scoreno score
ShapeCAPSULE (Capsule) Size24mm
FlavorImprint Code U;96
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-117-141 in 1 CARTON09/30/2014
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:13107-117-282 in 1 CARTON09/30/2014
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:13107-117-423 in 1 CARTON09/30/2014
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20492309/30/2014
Labeler - Aurolife Pharma, LLC (829084461)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(13107-117)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma LLC078296263RELABEL(13107-117) , REPACK(13107-117) , LABEL(13107-117) , PACK(13107-117)

Revised: 9/2019
Document Id: 1f2db15b-a212-4eff-9cad-c971a5a89da4
Set id: bfaf1e69-cbe9-4dde-8f65-6e730f47120a
Version: 2
Effective Time: 20190911
 
Aurolife Pharma, LLC