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

  • NDC Code(s): 70369-001-01
  • 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 April 16, 2018

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

  • Drug Facts

    Active ingredient (in each tablet)

    Sodium Bicarbonate 10 gr (650 mg)

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  • Purpose

    Antacid

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  • Uses

    relieves:

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

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  • 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
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  • Other information

    each tablet contains: sodium 178 mg

    store at room temperature 15º - 30º C (59º - 86º F)

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  • Inactive ingredients

    Hydrogenated Vegetable Oil, NF and Microcrystalline Cellulose, NF

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  • Questions or comments?

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

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE  10 GR (650 MG)
    sodium bicarbonate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70369-001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 650 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 11mm
    Flavor Imprint Code CG001
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70369-001-01 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/16/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 04/16/2018
    Labeler - CitraGen Pharmaceuticals Inc. (024949457)
    Registrant - CitraGen Pharmaceuticals Inc. (024949457)
    Establishment
    Name Address ID/FEI Business Operations
    CitraGen Pharmaceuticals Inc 024949457 manufacture(70369-001)
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