Label: SAL DE UVAS PICOT - sodium bicarbonate and citric acid powder, for solution

  • NDC Code(s): 64613-0456-4
  • Packager: Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/11

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  • Drug Facts


    Active Ingredients
    (in each packet)
    Sodium Bicarbonate 2.485 g
    Citric Acid 1.9485 g
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  • PURPOSE

    Purpose
    Antacid

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  • INDICATIONS & USAGE

    Uses for the relief of:
    * heartburn * sour stomach and acid indigestion * upset stomach associated with these symptoms

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  • WARNINGS

    Warnings
    Do not use * more than 4 packets in 24 hours * more than 3 packets in 24 hours if you are 60 years and older * the maximum dosage of this product for more than 2 weeks, except under the advise and supervision of a physician.

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

    Ask a doctor or pharmacist before use if you are * presently taking a prescription drug (antacids may interact with certain prescription drugs) * presently on a sodium diet

    In case of overdose, get medical help or contact a Poison Control Center right away


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  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children

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  • DOSAGE & ADMINISTRATION


    Directions
    * adults and children 12 years and over dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor * children under 12 years consult a doctor Close
  • STORAGE AND HANDLING


    Other information
    * each packet contains 712 mg of sodium * store in a cool, dry place

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  • INACTIVE INGREDIENT


    Inactive ingredients
    sucrose, tartaric acid, silicon dioxide

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  • PRINCIPAL DISPLAY PANEL


    UPSET STOMACH  sal de uvas picot

    8 packets

    Net Wt 5 g (0.17 oz) each

    Antacid

    Sodium Bicarbonate and Citric Acid

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  • INGREDIENTS AND APPEARANCE
    SAL DE UVAS PICOT 
    antacid powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64613-0456
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 2.485 g
    CITRIC ACID (CITRIC ACID) CITRIC ACID 1.948 g
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    SUCROSE  
    TARTARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64613-0456-4 8 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 01/11/2011
    Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211)
    Establishment
    Name Address ID/FEI Business Operations
    Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. 823646211 manufacture
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