Label: SODIUM BICARBONATE tablet

  • NDC Code(s): 55154-6754-0
  • Packager: Cardinal Health 107, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 7, 2024

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

  • Active ingredient

    Drug Facts

    In each tablet: Sodium Bicarbonate 10 gr (650 mg)

    Each tablet contains: sodium 178 mg
  • Purpose

    Antacid

  • Indications and Usage

    Relieves -

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

  • Warnings

    This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

    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 the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

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

  • Directions

     
    See product insert for prescribing information, precautions and warnings.
    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 or over: 1-2 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.
  • Inactive ingredients

    Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

    Storage and Handling

    Store at room temperature 15° - 30°C (59° - 86°F)

  • Other

    Manufactured For and Distributed By:

    Hospak® Unit Dose Products, Huntley, IL 60142

    Questions or comments? 1-847-458-5308

    Hospak®

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L40866170518

    Rev. 8/17

  • Principal Display Panel

    SODIUM BICARBONATE, USP

    650 mg (10 Grain)

    ANTACID TABLETS

    10 TABLETS

    650mg bag label
  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6754
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code CL;206
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-6754-010 in 1 BAG06/06/201110/31/2026
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/06/201110/31/2026
    Labeler - Cardinal Health 107, LLC (118546603)