Label: SODIUM BICARBONATE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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  • Drug Facts

    Active ingredient (in each tablet)

    Sodium bicarbonate 10 gr (650 mg)

  • PURPOSE

    Purpose

    Antacid

  • Uses

    relieves:

     acid indigestion

     heartburn

     sour stomach

     upset stomach associated with these symptoms

  • Warnings

    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 Doctor

    before use if you have a sodium restricted diet.

    Ask Doctor/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 two weeks.

    Pregnancy or Breast Feeding

    ask a health professional before use.

    Keep

    Out of Reach of Children

    Other Safety Information

    In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

    This Unit Dose package

    is not child resistant and is Intended for Institutionals Use Only.

    DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

  • Directions

     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 ageand over: 1-2 tablets 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

  • Other information

     each tablet contains: sodium 178 mg  store in a dry place at 15° – 30°C (59° – 86°F)  Retain this carton for important information.

  • Inactive Ingredients

    croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc

  • Questions or comments?

    (800) 616-2471

  • Distributed by:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    www.majorpharmaceuticals.com

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L58544760224

    Rev. 05/22

    M-29

    Re-order No. 701316

    WARNING:

    This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

  • Principal Display Panel

    SODIUM BICARBONATE

    10 gr (650 mg)

    ANTACID

    10 TABLETS

    10gr (650mg) bag label
  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4324(NDC:0904-7261)
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code CPC;77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-4324-010 in 1 BAG10/26/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00110/26/2022
    Labeler - Cardinal Health 107, LLC (118546603)
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