SODIUM BICARBONATE- sodium bicarbonate tablet 
TWIN MED 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 650 mg

Drug Facts

Active ingredient (in each tablet)

Sodium Bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

relieves

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.

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.

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

Inactive ingredients

Microcrystalline cellulose and stearic acid, magnesium stearate

Questions or comments?

Questions ? call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL - 1000 Tablet Bottle Label

NDC 55681-331-10

Sodium Bicarbonate

Tablets, USP

10 gr (650 mg)

ANTACID

BICARB

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE650 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code S65
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-331-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/10/2022
Labeler - TWIN MED LLC (009579330)

Revised: 3/2023
Document Id: f7f1bb4e-df0f-8a7b-e053-6294a90a9c47
Set id: f7f1bec4-452f-8fdc-e053-6294a90a3989
Version: 1
Effective Time: 20230325
 
TWIN MED LLC