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

  • 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 November 21, 2019

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  • Drug Facts

  • Active Ingredients (in each packet)

    Citric acid 1.9485 g
    Sodium bicarbonate 2.4850 g

    Purposes

    Antacid

  • 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 1/2 glass of water before taking
    adults 60 years and over 1 packet every 4 hours, or as directed by a doctor. Do not exceed 3 packets in 24 hours
    adults and children 12 to 60 years one packet every 4 hours or as directed by a doctor. Do not exceed 4 packets in 24 hours
    children under 12 years  ask a doctor

  • Other information

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

    silicon dioxide, sucrose, tartaric acid

  • Questions or Comments?

    call 1-844-700-9956

  • Package Labeling:

    Sal De Uvas Picot

  • INGREDIENTS AND APPEARANCE
    SAL DE UVAS PICOT 
    citric acid monohydrate, sodium bicarbonate granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-174(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) 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:67751-174-011 in 1 CARTON09/23/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/23/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-174) , repack(67751-174)
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