GRIPE WATER LIQUID [VITALITY WORKS]

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  • GRIPE WATER LIQUID [VITALITY WORKS]

GRIPE WATER LIQUID [VITALITY WORKS]
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NDC 64616-119-01, 64616-119-02
Set ID 45ade734-f446-4370-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Vitality Works
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredients

    (In equal parts) Chamomila 3x (Chamomile) HPUS, Mentha Piperita 3x (Peppermint) HPUS, Zingaber Officianale 3x (Ginger) HPUS, and Foeniculum Vulgare 3x (Fennel) HPUS.

  • Inactive Ingredients:

    USP Purified Water, Vegetable Glycerin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions:

    Newborn, 0.5 ml tthree times per day or as needed. 6 months, 1.0 ml three times per day or as needed.

    To be used according to standard homepoathic indications

  • PURPOSE

    For infant relief of irritiability, hiccups, gas releif, digestive aid, bloating and colic.

  • Questions

    info@maxihealth.com

  • WARNINGS

    Store tightly in a cool dry place. Keep out of reach of childre,To be used according to standard homeopathic indications.

  • INDICATIONS & USAGE

    For relief of irritability, hiccips, gas relief, digestive aid, bloating and colic

  • PRINCIPAL DISPLAY PANEL

    primary label

  • INGREDIENTS AND APPEARANCE
    GRIPE WATER 
    gripe water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE1 [hp_X]  in 0.0025 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA1 [hp_X]  in 0.0025 mL
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) (ZINGIBER OFFICINALE WHOLE - UNII:IN6Q3S3414) ZINGIBER OFFICINALE WHOLE1 [hp_X]  in 0.0025 mL
    FOENICULUM VULGARE VAR. VULGARE WHOLE (UNII: R9S0526LYO) (FOENICULUM VULGARE VAR. VULGARE WHOLE - UNII:R9S0526LYO) FOENICULUM VULGARE VAR. VULGARE WHOLE1 [hp_X]  in 0.0025 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-119-021 in 1 CARTON08/29/2017
    1NDC:64616-119-0159.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/2017
    Labeler - Vitality Works (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-119) , label(64616-119)
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