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SODIUM BICARBONATE by Aphena Pharma Solutions - Tennessee, LLC

Dosage form: tablet
Ingredients: SODIUM BICARBONATE 650mg
Labeler: Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 43353-162

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.

SODIUM BICARBONATE 10 gr (650 mg)

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

PURPOSE

Antacid

Indications:

Relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

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:
  • Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
  • Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
  • Dissolve tabelt completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:
  • each tablet contains: sodium 178 mg 
  • store at room temperature 15 °- 30 °C (59 °- 86 °F).

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:

Cookeville, TN 38506

20171213JH

PRINCIPAL DISPLAY PANEL - 650 mg

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

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-162(NDC:54738-020)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MICROCRYSTALLINE CELLULOSE 
STEARIC ACID 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUND (round) Size11mm
FlavorImprint CodeAP;119
Contains    
Packaging
#Item CodePackage Description
1NDC:43353-162-5360 TABLET in 1 BOTTLE, PLASTIC
2NDC:43353-162-6090 TABLET in 1 BOTTLE, PLASTIC
3NDC:43353-162-70120 TABLET in 1 BOTTLE, PLASTIC
4NDC:43353-162-80180 TABLET in 1 BOTTLE, PLASTIC
5NDC:43353-162-85200 TABLET in 1 BOTTLE, PLASTIC
6NDC:43353-162-94360 TABLET in 1 BOTTLE, PLASTIC
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/FEIOperations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-162)

 
Aphena Pharma Solutions - Tennessee, LLC

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Medically reviewed on Dec 13, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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