Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet

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

Drug Label Information

Updated December 6, 2023

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  • Drug Facts

    Active ingredient (in each tablet)

    Sodium bicarbonate 5 gr (325 mg)

  • Purpose

    Antacid

  • Uses

    relieves

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

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

    Keep out of reach of children.

  • 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 age and over: 2-4 tablets every 4 hours, not more than 24 tablets in 24 hours
    • adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

  • Other information

    • each tablet contains: sodium 89 mg
    • Store in a dry place at 15º - 30ºC (59º - 86º F)
  • Inactive ingredients

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

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

    DISTRIBUTED BY:

    RUGBY® LABORATORIES

    INDIANAPOLIS, IN 46268

    Questions or comments?

    Call (800) 616-2471

    www.majorpharmaceuticals.com

    Rev. 10/23 R-29

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 0536-1046-10

    Sodium Bicarbonate 5 gr (325 mg)

    ANTACID

    1000 WHITE TABLETS

    Rugby Label

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE ANTACID 
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code CPC76
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1046-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/25/2015
    Labeler - Rugby Laboratories (079246066)
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