Label: SAL DE UVAS PICOT- citric acid monohydrate and sodium bicarbonate granule, effervescent

  • NDC Code(s): 70565-580-01, 70565-580-02, 70565-580-03, 70565-580-04
  • Packager: Reckitt Benckiser Mexico, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 December 10, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Citric acid 1.9485 gAntacid
    Sodium bicarbonate (heat-treated) 2.4850 gAntacid
  • Uses

    for the relief of

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

    Do not take more than directed or use the maximum dosage of this product 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 presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    • fully dissolve one packet in ½ glass of water every 4 hours or as directed by a doctor
    • adults 60 years of age and over: do not exceed 3 packets in 24 hours
    • adults and children 12 to 60 years of age: do not exceed 4 packets in 24 hours
    • children under 12 years of age: ask a doctor
  • Other information

    • each packet contains: sodium 712 mg
    • store in a cool, dry place
    • store between 20-25ºC (68-77ºF)
  • Inactive ingredients

    silicon dioxide, sucrose, tartaric acid

  • Questions ?

    1-844-700-9956

  • PRINCIPAL DISPLAY PANEL - 12 Packet Carton

    UPSET
    STOMACH

    sal de uvas
    picot    ®

    12 packets

    Citric Acid•Antacid
    Sodium Bicarbonate•Antacid
    Effervescent Powder for Solution

    PRINCIPAL DISPLAY PANEL - 12 Packet Carton
  • INGREDIENTS AND APPEARANCE
    SAL DE UVAS PICOT 
    citric acid monohydrate and sodium bicarbonate granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70565-580
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Citric Acid monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1.9485 g
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37, Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate2.485 g
    Inactive Ingredients
    Ingredient NameStrength
    Silicon dioxide (UNII: ETJ7Z6XBU4)  
    Sucrose (UNII: C151H8M554)  
    Tartaric acid (UNII: W4888I119H)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70565-580-016 in 1 CARTON03/31/2016
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:70565-580-028 in 1 CARTON03/31/2016
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:70565-580-0312 in 1 CARTON03/31/2016
    31 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:70565-580-0450 in 1 CARTON03/31/2016
    41 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33103/31/2016
    Labeler - Reckitt Benckiser Mexico, S.A. de C.V. (810061093)
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