SODIUM BICARBONATE 10 GR- sodium bicarbonate tablet 
GRAXCELL PHARMACEUTICAL, 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), 70795-1140 (DELISTED)

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

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 or 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

Drug Interaction Precaution

Stomach Warning

  • TO AVOID SERIOUS INJURY, D0 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. Maxlmum 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.

D0 NOT EXCEED RECOMMENDED DOSE

Not recommended for children.

Other information

  • each tablet contains : sodium 178 mg (7.74 meg)
  • 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

Questions or comments?

Call toll free 1-888-266-8818

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

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SODIUM BICARBONATE 10 GR 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1140
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
STARCH, CORN (UNII: O8232NY3SJ)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code G57
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70795-1140-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
2NDC:70795-1140-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/02/201704/19/2021
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 12/2021
Document Id: d3ae1923-5107-2f5e-e053-2a95a90a6d92
Set id: 51b37946-450e-4098-92a4-db3d73c1b568
Version: 6
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC