Label: DIGESTION-BLOATING-GAS- triplex pill

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 22, 2020

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  • Active Ingredient(s)

    Anise Dry Extract 2%

    Dry Fennel Extract 2%

  • Purpose

    Light and Ease of Digestion

  • Use

    Take 1 tablet 3-4 times a day when having issues with digestion

  • Warnings

    No more than 6 tablets in a day.

    Keep away from children

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If any issues occur get medical help or contact a Poison Control Center right away.

  • Directions

    • Take 1 tablet 3-4 times a day.
    • Children under 12 years of age should not use product
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Magnesium stearate, non-hydrogenated vegetable oil, Menthol, Star Asine essential oil,Stevia Powder

  • Package Label - Principal Display Panel

    16 U NDC: 79394-000-01

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  • INGREDIENTS AND APPEARANCE
    DIGESTION-BLOATING-GAS 
    triplex pill
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79394-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL2 mg  in 100 mg
    ANISE OIL (UNII: 6Y89129C8H) (ANISE OIL - UNII:6Y89129C8H) ANISE OIL2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    STAR ANISE OIL (UNII: 6RXP35EIRE)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    MENTHOL (UNII: L7T10EIP3A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorANISEImprint Code TX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79394-000-0124000 mg in 1 DOSE PACK; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - L'ENVOL PHARMA (362865293)
    Registrant - L'ENVOL PHARMA (362865293)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'ENVOL PHARMA362865293manufacture(79394-000)
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