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Sodium Bicarbonate Antacid by Compania Farmaceutica, S.A. de C.V.

Dosage form: powder
Ingredients: SODIUM BICARBONATE 1g in 1g
Labeler: Compania Farmaceutica, S.A. de C.V.
NDC Code: 71230-001

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 Powder Antacid

Active ingredient (in each 1/2 teaspoon)

Sodium bicarbonate 2.52 g

Purpose

Antacid

Uses
  • For the relief of heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

Warnings

Do not use‚Äč

  • more than 3 teaspoons for persons up to 60 years old
  • more than 1½ teaspoons for persons 60 years or older in a 24-hour period
  • more than the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

Ask a doctor or pharmacist before use if you

are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Persons Up To 60 Years Old: Take ¼ to ½ teaspoon up to 4 times a day
  • Persons 60 Years or Older: take ¼ teaspoon up to 4 times a day or ½ teaspoon up to 3 times a day.

Other information
  • Sodium Content per ½ tsp. 685 mg
  • Store at 86°F/30°C or cooler

Inactive ingredients

none

Package Labeling:

SODIUM BICARBONATE ANTACID 
sodium bicarbonate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71230-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:71230-001-1212 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/16/2017
Labeler - Compania Farmaceutica, S.A. de C.V. (816053340)

Revised: 02/2017
 
Compania Farmaceutica, S.A. de C.V.

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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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