Label: SODIUM BICARBONATE 10 GR (650 MG)- sodium bicarbonate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Drug Facts

    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 takemore 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.

    Ask a doctor before use if you havea sodium restricted diet.

    Ask a doctor or pharmacist before use if you aretaking a prescription drug.

    Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor ifsymptoms last more than 2 weeks.

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

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • do not use the maximum dosage for more than 2 weeks
    • tablets may be swallowed whole or dissolved in water prior to use
    • adults 60 years of age and over:1-2 tablets every 4 hours, not more than 12 tablets in 24 hours
    • adults under 60 years of age:1-4 tablets every 4 hours, not more than 24 tablets in 24 hours
  • Other information

    each tablet contains: sodium 178 mg (7.74 mEq)

    store at room temperature 15º - 30º C (59º - 86º F) in a well closed container as defined in the USP

  • Inactive ingredients

    Microcrystalline cellulose and stearic acid

  • Questions or comments?

    1-833-687-7786

  • SPL UNCLASSIFIED SECTION

    Manufactured for and Distributed By:

    Unity Pharma

    Covina, Ca 91723 USA

    Rev. 09/24

  • PRINCIPAL DISPLAY PANEL

    Unity Pharma

    NDC: 84275-503-10

    Sodium Bicarbonate Tablets, USP 10 gr (650 mg)

    ANTACID

    1000 Tablets

    sod-bicar-unity

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE  10 GR (650 MG)
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84275-503
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84275-503-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00111/13/2024
    Labeler - Unity Pharma (116124438)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neeyaan LLC118819217manufacture(84275-503)
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