Label: SODIUM BICARBONATE 5 GR (325 MG)- sodium bicarbonate tablet

  • NDC Code(s): 70369-002-01
  • Packager: CitraGen Pharmaceuticals Inc.
  • 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 September 5, 2019

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

  • 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

    Do not take more than 48 tablets for adults up to 60 years of age (or 24 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 pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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

  • Inactive ingredients

    Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

  • Questions or comments?

    Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

  • SPL UNCLASSIFIED SECTION

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

    Manufactured by:
    CitraGen Pharmaceuticals, Inc.,
    Fremont, CA 94538.

    www.citragenpharma.com

    Rev. 03/18 R-00

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369-002-01

    Sodium Bicarbonate Tablets, USP 5 gr (325 mg)

    ANTACID

    1000 Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE  5 GR (325 MG)
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70369-002
    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
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code CG002
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70369-002-011000 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/20/2018
    Labeler - CitraGen Pharmaceuticals Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals Inc. (024949457)
    Establishment
    NameAddressID/FEIBusiness Operations
    CitraGen Pharmaceuticals Inc024949457manufacture(70369-002)