Label: SODIUM BICARBONATE 10 GR (650 MG)- sodium bicarbonate tablet

  • NDC Code(s): 70369-001-01, 70369-001-08
  • Packager: CitraGen Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 30, 2025

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  • Drug Facts

    Active ingredient (in each tablet)

    Sodium Bicarbonate 10 gr (650 mg)

  • 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 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: 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 at room temperature 15º - 30º C (59º - 86º 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: 70369-001-01

    Sodium Bicarbonate Tablets, USP 10 gr (650 mg)

    ANTACID

    1000 Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    Bottle Label

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369-001-08

    Sodium Bicarbonate Tablets, USP 10 gr (650 mg)

    ANTACID

    120 Tablets

    120's Count Label

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE  10 GR (650 MG)
    sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70369-001
    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
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize11mm
    FlavorImprint Code CG001
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70369-001-011000 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2018
    2NDC:70369-001-08120 in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00104/16/2018
    Labeler - CitraGen Pharmaceuticals Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals Inc. (024949457)
    Establishment
    NameAddressID/FEIBusiness Operations
    CitraGen Pharmaceuticals Inc024949457manufacture(70369-001)
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