Label: SODIUM BICARBONATE tablet

  • 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 December 13, 2017

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  • Drug Facts

    Active Ingredient (in each tablet)

    Sodium bicarbonate 10 gr (650 mg)

  • PURPOSE

    Antacid

  • Indications:

    Relieves:

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

    Ask a doctor or pharmacist

    • if you are on a sodium-restricted diet.
    • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
    • if symptons last more than 2 weeks

    As with any drug, if you are pregnant or nursing a baby, seek advise of a health professional before using this product.

  • Directions:

    • Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
    • Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
    • Dissolve tabelt completely in water before drinking.
    • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
  • Other Information:

    • each tablet contains: sodium 178 mg 
    • store at room temperature 15 °- 30 °C (59 °- 86 °F).
  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

  • OVERDOSAGE

    In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • INACTIVE INGREDIENT

    croscarmellose sodium, microcrystalline cellulose, stearic acid

  • Questions or Comments

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

    call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count650 mg
    6043353-162-53
    9043353-162-60
    12043353-162-70
    18043353-162-80
    20043353-162-85
    36043353-162-94

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20171213JH

  • PRINCIPAL DISPLAY PANEL - 650 mg

    NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only
    Bottle Label 650 mg

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-162(NDC:54738-020)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUND (round) Size11mm
    FlavorImprint Code AP;119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43353-162-5360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2016
    2NDC:43353-162-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
    3NDC:43353-162-70120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
    4NDC:43353-162-80180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2016
    5NDC:43353-162-85200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2016
    6NDC:43353-162-94360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/01/2015
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-162)
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