Label: COMFORT FOR COLIC- comfort for kids liquid

  • 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 28, 2023

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  • Indications

    For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability.

    For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability

  • Directions

    Do not use if printed neck seal is broken or missing, use only as directed. For infants up to 3 years of age: give 4 dropsunder the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours as needed or recommended by a doctor.

  • Active Ingredients

    Chamomilla (Chamomile) 4X, Colocynthsis (Bitter cucumber) 4X, Pulsatilla (Wind flower) 4X, Aethusa cynapium (Fools parsley) 6x, Dioscorea villosa (wild yam) 6X, Magnesia Phosphorica (Magensium phophate) 6X

  • Inactive ingredients

    USP Purified water, Vegetable glycerin

  • Warnings

    Stop use and ask a doctor if

    symptoms do not improve in 7 days or if new symptoms appear

    if your child experiences recurring gastrointestinal upsets, frequent headaches or persistent fatigue

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

  • Comments or Questions

    Health for Kids Shelbourne Falls, MA 01370 USA

    1-800-255-4463

    www.herbsforkids.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    COMFORT FOR COLIC 
    comfort for kids liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS4 [hp_X]  in 0.05 mL
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM4 [hp_X]  in 0.05 mL
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER6 [hp_X]  in 0.05 mL
    MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z) MAGNESIUM PHOSPHATE, DIBASIC6 [hp_X]  in 0.05 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE4 [hp_X]  in 0.05 mL
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT4 [hp_X]  in 0.05 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-116-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/05/2013
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817label(64616-116) , manufacture(64616-116)
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