SODIUM BICARBONATE- sodium bicarbonate tablet 
Aphena Pharma Solutions - Tennessee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Bicarbonate Tablets

SODIUM BICARBONATE - sodium bicarbonate tablet

Marlex Pharmaceuticals, Inc.      

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Bicarbonate

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Sodium bicarbonate 5gr (325 mg)

Purpose

Antacid

Uses

Relieves

Warnings

Ask a doctor before use if you have

a sodium restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

symptoms last more than 2 weeks

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

325mg,

650mg,

Other information

     sodium 178 mg (650mg) 

Inactive ingredients

Pregelatinized starch, NF and mineral oil, USP

 Questions or comments?

Call toll free 1-888-266-8818

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count650 mg
6071610-445-53
9071610-445-60
18071610-445-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20200723JH

PRINCIPAL DISPLAY PANEL - 650 mg

NDC 71610-445 - Sodium Bicarbonate 650 mg Tablets
Bottle Label 650 mg

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-445(NDC:10135-685)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code G57
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-445-5360 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
2NDC:71610-445-6090 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
3NDC:71610-445-80180 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2020
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-445)

Revised: 7/2020
Document Id: 18daabfe-0f66-436b-bb87-d8694d00767b
Set id: 2928c7d3-1bcf-49cf-af9f-baabf4f7da27
Version: 1
Effective Time: 20200723
 
Aphena Pharma Solutions - Tennessee, LLC