Label: SODIUM BICARBONATE 5 GR- sodium bicarbonate tablet, soluble

  • 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 August 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Sodium bicarbonate 5 gr

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

    Ask a doctor before use if you have a sodium restricted diet

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use the maximum dosage for more than 2 weeks
    • dissolve tablets completely in water prior to use
    • adults 60 years of age and over: 2-8 tablets every 4 hours, not more than 24 tablets in 24 hours
    • adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours
  • STORAGE AND HANDLING

    Other information

    • each tablet contains: sodium 89 mg
    • store at room temperature 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    croscarmellose sodium, microcrystalline cellulose, stearic acid

  • QUESTIONS

    Questions or comments?

    call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-035-10

    Sodium Bicarbonate 5 gr

    ANTACID

    1000 TABLETS

    Sodium

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 5 GR 
    sodium bicarbonate tablet, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-035
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE324 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AP120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-035-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
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