Label: SODIUM BICARBONATE- sodium bicarbonate tablet, orally disintegrating

  • 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 18, 2017

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  • Drug Facts

    Active ingredients (in each tablet)
    Sodium Bicarbonate 10 gr (650mg)     		Purpose
    Antacid
  • Indications:

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

  • Warnings

    Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more 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 maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

  • Stomach Warning:

    TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

  • INDICATIONS & USAGE

  • Drug Interaction Precaution: 

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

  • Directions:

    Adults -Take 1 tablet, dissolved in a glass of water, as needed. • Maximum daily dose for adults up to 60 years of age is 24 tablets. • Maximum daily dose for adults 60 years of age or older is 12 tablets. • Dissolve completely in water before drinking. • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

  • Other Information:

    Each tablet contains: sodium 178 mg (7.74 meq) ·store at room temperature 15°·30°C (59°-86°F) in well-closed containers as defined in the USP.

  • Inactive Ingredients: 

    Pregelatinized starch, NF and mineral oil, USP.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • 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:

    Count650mg
    6043353-041-53
    9043353-041-60
    12043353-041-70
    18043353-041-80
    20043353-041-85
    36043353-041-94

    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

    20160628DH

  • PRINCIPAL DISPLAY PANEL

          NDC 43353-041-53

    Sodium
    Bicarbonate
    Antacid

    60 Tablets

    PRINCIPAL DISPLAY PANEL - 60 tablets
  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE  
    sodium bicarbonate tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-041(NDC:64980-182)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate650 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code CL;206
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43353-041-5360 in 1 BOTTLE; Type 0: Not a Combination Product07/14/2015
    2NDC:43353-041-6090 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2015
    3NDC:43353-041-70120 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2015
    4NDC:43353-041-80180 in 1 BOTTLE; Type 0: Not a Combination Product06/05/2015
    5NDC:43353-041-85200 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2015
    6NDC:43353-041-94360 in 1 BOTTLE; Type 0: Not a Combination Product07/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/26/2012
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-041)
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