PAIN AND FEVER KIDS RELIEF (ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE) LIQUID [HOMEOLAB USA INC]

PAIN AND FEVER KIDS RELIEF (ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE) LIQUID [HOMEOLAB USA INC]
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NDC 60512-9079-8
Set ID 6e139153-86d2-472d-9b1a-1c45a2bc695f
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients HPUS:

    Arnica montana (Leopard's bane) 8X


    Ferrum phosphoricum (Ferrosoferric phosphate) 8X


    Hypericum perforatum (St John's wort) 8X


    Belladonna (Deadly nightshade) 8X

    Calculated as 0.0000003% alkaloids


    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


    Fever, shooting pain, headache, sore throat


    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 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

    image of carton label

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER KIDS RELIEF 
    arnica montana, ferrum phosphoricum, hypericum perforatum, belladonna, thuja occidentalis, ledum palustre liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9079
    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
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA8 [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:60512-9079-81 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/10/2010
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9079)

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