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Sodium Bicarbonate by Aphena Pharma Solutions - Tennessee, LLC

Medically reviewed on August 18, 2017

Dosage form: tablet, orally disintegrating
Ingredients: Sodium Bicarbonate 650mg
Labeler: Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 43353-041

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 Tablets, USP
Antacid

Drug Facts
Active ingredients (in each tablet)
Sodium Bicarbonate 10 gr (650mg)
Purpose
Antacid

Indications:

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

Warnings

Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Stomach Warning:

TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interaction Precaution: 

Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions:

Adults -Take 1 tablet, dissolved in a glass of water, as needed. • Maximum daily dose for adults up to 60 years of age is 24 tablets. • Maximum daily dose for adults 60 years of age or older is 12 tablets. • Dissolve completely in water before drinking. • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information:

Each tablet contains: sodium 178 mg (7.74 meq) ·store at room temperature 15°·30°C (59°-86°F) in well-closed containers as defined in the USP.

Inactive Ingredients: 

Pregelatinized starch, NF and mineral oil, USP.

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.

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:

Count650mg
6043353-041-53
9043353-041-60
12043353-041-70
18043353-041-80
20043353-041-85
36043353-041-94

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

20160628DH

PRINCIPAL DISPLAY PANEL

      NDC 43353-041-53

Sodium
Bicarbonate
Antacid

60 Tablets

SODIUM BICARBONATE  
sodium bicarbonate tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-041(NDC:64980-182)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MINERAL OIL 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeCL;206
Contains    
Packaging
#Item CodePackage Description
1NDC:43353-041-5360 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2NDC:43353-041-6090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
3NDC:43353-041-70120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
4NDC:43353-041-80180 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
5NDC:43353-041-85200 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
6NDC:43353-041-94360 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/26/2012
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-041)

 
Aphena Pharma Solutions - Tennessee, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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