Label: SODIUM BICARBONATE tablet

  • 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 December 3, 2019

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

  • Active ingredient

    Drug Facts

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

  • Purpose

    Antacid

  • 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.

  • Uses

    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 the 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.

    DRUG INTERACTION PRECAUTION: Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

  • 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.
  • Inactive ingredients

    Pregelatinized starch, NF and mineral oil, USP.

  • Other

    ·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.

    Questions ? 1-815-877-6480

    Manufactured For and Distributed By: Hospak® Unit Dose Products, Huntley, IL 60142

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L40866170518

    Rev. 8/17

  • Principal Display Panel

    Sodium Bicarbonate

    10 gr (650 mg)

    Antacid Tablets

    10 Tablets

    bag label
  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6754(NDC:66553-008)
    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 BAG06/06/2011
    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 other06/06/2011
    Labeler - Cardinal Health (603638201)