KIDS RELIEF COUGH AND COLD (DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM) SYRUP [HOMEOLAB USA INC]

KIDS RELIEF COUGH AND COLD (DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM) SYRUP [HOMEOLAB USA INC]
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NDC 60512-9210-4, 60512-9210-5, 60512-9210-9
Set ID 0584a8b2-a6fa-4d69-a2c5-6feb14e9767b
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
  • Active ingredients HPUS:

    Drosera (Sundew) 1C

    Arnica montana (Leopard`s bane) 3C

    Bryonia (White bryony) 3C

    Ipecacuanha (Ipecac) 3C

    Cetraria islandica (Iceland moss) 1C

    Coccus cacti (Cochineal) 3C

    Corallium rubrum (Red coral) 3C

    Stannum metallicum (Tin) 3C

  • Purpose

    Dry cough

    Aches and pains, chest congestion

    Painful cough, fever

    Night cough

    Cough with expectoration

    Cough with expectoration

    Painful cough

    Cough, chills and lessens mucus

  • 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.

  • Uses

    This homeopathic medicine is made from a combination of ingredients tracitionally used tohelp relieve symptoms associated with cough and cold*:

    - dry cough

    - cough with expectoration

    - chest congestion

    - fever

    - aches and pains

  • WARNINGS


    Stop use and ask a doctor if

    - pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

    - fever gets worse or lasts more than 3 days

    - redness or swelling is present

    - new symptoms occur

    - cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

    Keep out of reach of children. In case of accidental overdose, contact a medical professional 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: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

    Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

  • Other information

    Store at room temperature.

    Do not use if seal under bottle cap is broken or missing.

  • Inactive ingredients

    Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.

  • CARTON

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF COUGH AND COLD 
    drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP1 [hp_C]  in 100 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]  in 100 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]  in 100 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 100 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9210-51 in 1 CARTON11/01/2016
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:60512-9210-41 in 1 CARTON11/04/2016
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:60512-9210-91 in 1 CARTON11/04/2016
    3250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2016
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9210)

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