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 10 gr (650 mg)

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

PURPOSE

Antacid

Indications:

Relieves:

Warnings

Ask a doctor or pharmacist

  • if you are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if symptons last more than 2 weeks

As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

Directions:

Other Information:

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

INACTIVE INGREDIENT

croscarmellose sodium, microcrystalline cellulose, stearic acid

Questions or Comments

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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
6043353-162-53
9043353-162-60
12043353-162-70
18043353-162-80
20043353-162-85
36043353-162-94

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

20171213JH

PRINCIPAL DISPLAY PANEL - 650 mg

NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only
Bottle Label 650 mg

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-162(NDC:54738-020)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size11mm
FlavorImprint Code AP;119
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43353-162-5360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2016
2NDC:43353-162-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
3NDC:43353-162-70120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
4NDC:43353-162-80180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2016
5NDC:43353-162-85200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2016
6NDC:43353-162-94360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/2015
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-162)

Revised: 12/2017
Document Id: 36d1abdc-f28b-4c0d-98ea-07718706c695
Set id: 15605a6d-6c90-47d5-9d1f-f66a3f27d5fc
Version: 1
Effective Time: 20171213
 
Aphena Pharma Solutions - Tennessee, LLC