Label: SODIUM BICARBONATE tablet

  • NDC Code(s): 52682-206-04
  • Packager: Ingenus Pharmaceuticals NJ, LLC
  • 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 15, 2022

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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

    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 advise 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 upto 60 years of age is 24 tablets.
    • Maximum daily dose for adults 60 years of age and 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 mieral oil, USP.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    ingenus

    NDC 52682-206-04

    SODIUM BICARBONATE

    10 gr (650 mg)

    Antacid

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

    1000 Tablets

    Mfd. by Ingenus Pharmaceuticals NJ, LLC

    Fairfield, NJ 07004

    SODIUM BICARBONATE 10 gr (650 mg), 1000 Tablets

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52682-206
    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
    ColorWHITE (White) Score2 pieces
    ShapeROUND (round) Size11mm
    FlavorImprint Code CL;206
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52682-206-041000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/201104/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/24/201104/01/2025
    Labeler - Ingenus Pharmaceuticals NJ, LLC (964680206)
    Registrant - Ingenus Pharmaceuticals NJ, LLC (964680206)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ingenus Pharmaceuticals NJ, LLC964680206manufacture(52682-206) , analysis(52682-206) , label(52682-206) , pack(52682-206)
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