Label: GRIPE WATER liquid

  • NDC Code(s): 64616-119-01, 64616-119-02
  • Packager: Vitality Works
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 30, 2021

If you are a consumer or patient please visit this version.

  • 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)