Label: KIDS RELIEF PAIN AND FEVER- arnica montana, ferrum phosphoricum, hypericum perforatum, thuja occidentalis, ledum palustre 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 April 13, 2017

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  • Active Ingredients HPUS:

    Arnica montana (Leopard's bane) 8X


    Ferrum phosphoricum (Ferrosoferric phosphate) 8X


    Hypericum perforatum (St John's wort) 8X

    Thuja occidentalis (White cedar) 8X


    Ledum palustre (Wild rosemary) 8X

  • Purpose

    Fever, aches and pains, headache, sore throat


    Fever, inflammation


    Pain in the extremities, toothache, fever

    Sinus congestion, headache, muscular pain


    Chills and fever

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

    RETAIN CARTON FOR COMPLETE INSTRUCTIONS

  • Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help temporarily reduce fever and relieve minor aches and pains associated with*:

    • common cold

    • headache

    • sore throat

    • toothache

  • Warnings


    Do not use if imprinted shrink seal neckband on bottle is broken or missing.

    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist.

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

  • DIRECTIONS

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

    Children 2 to 12 years old: 0.75 ml orally every 8 hours or 3 times a day.

  • OTHER INFORMATION

    Store at room temperature.

  • Inactive Ingredients

    Purified water, sorbitol, cherry flavor, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    carton

  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF PAIN AND FEVER 
    arnica montana, ferrum phosphoricum, hypericum perforatum, thuja occidentalis, ledum palustre liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9216
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]  in 25 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]  in 25 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 25 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG8 [hp_X]  in 25 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG8 [hp_X]  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9216-81 in 1 CARTON10/21/2016
    125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/21/2016
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9216)
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