Label: SODIUM BICARBONATE powder

  • NDC Code(s): 10095-100-01, 10095-100-02
  • Packager: World Perfumes Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 10, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient(s)

    Sodium Bicarbonate 100%. Purpose: Antacid

  • Purpose

    Antacid

  • Use

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

  • Warnings

    Do not take more than maximum daily dosage. Do not take more than four 1/4 teaspoonfuls in a 24 hour period. Do not use the maximum dosage of this product for more than 2 weeks. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if you are on a sodium restricted diet. If preganat of breast feeding, ask a health professional before use.

  • Do not use

    • If you are on sodium restricted diet
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT REACH OF CHILDREN

  • Additional Warnings

    Stomach Warning: To avoid serious injury, do not take until powder is completely dissolved. it is very important not to take this product when overly full from food or drink. Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

  • Directions

    • Adults and children 12 years of age and over. Mix 1/4 Teaspoonful in water and drink.
    • Do not use more than 4 times a day.
    • For children under 12 years of age - ask a doctor
  • Other information

    • Store at controlled room temperature 15- 25C (59- 86F)
    • This package is sold by weight, not volume
    • Some setting of contents may have occured during shipping and handling
  • Inactive ingredients

    none

  • Tamper-Evident Disclosure:

    Do nt use if over-wrap bottle cap is torn broken or missing.

  • Package Label - Principal Display Panel

    Complete Label6 fl oz

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10095-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2.6 g  in 2.6 g
    Inactive Ingredients
    Ingredient NameStrength
    BICARBONATE ION (UNII: HN1ZRA3Q20) 0.1 g  in 2.6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10095-100-01113 g in 1 BOTTLE; Type 0: Not a Combination Product02/05/2020
    2NDC:10095-100-02170 g in 1 BOTTLE; Type 0: Not a Combination Product02/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/05/2020
    Labeler - World Perfumes Inc (101312044)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!