SODIUM BICARBONATE- sodium bicarbonate tablet 
Ingenus Pharmaceuticals NJ, 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)

Antacid

Indications:

Relieves:

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 the 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 advise 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:

Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions:

Other Information:

Inactive Ingredients:

Pregelatinized starch, NF and mieral 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.

ingenus

NDC 52682-206-04

SODIUM BICARBONATE

10 gr (650 mg)

Antacid

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

1000 Tablets

Mfd. by Ingenus Pharmaceuticals NJ, LLC

Fairfield, NJ 07004

SODIUM BICARBONATE 10 gr (650 mg), 1000 Tablets

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52682-206
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
MINERAL OIL (UNII: T5L8T28FGP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (White) Score2 pieces
ShapeROUND (round) Size11mm
FlavorImprint Code CL;206
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52682-206-041000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/201104/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/24/201104/01/2025
Labeler - Ingenus Pharmaceuticals NJ, LLC (964680206)
Registrant - Ingenus Pharmaceuticals NJ, LLC (964680206)
Establishment
NameAddressID/FEIBusiness Operations
Ingenus Pharmaceuticals NJ, LLC964680206manufacture(52682-206) , analysis(52682-206) , label(52682-206) , pack(52682-206)

Revised: 12/2022
Document Id: c4718b91-3d55-4894-a6c4-20c3838e74a9
Set id: 3cb67478-1a51-4e7d-a529-79029655f5d9
Version: 4
Effective Time: 20221215
 
Ingenus Pharmaceuticals NJ, LLC