Label: KIDS RELIEF COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA- drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha, cetraria islandica subsp. islandica, cochineal, corallium rubrum whole, stannum metallicum, chamomilla, coffea cruda kit

  • NDC Code(s): 71971-6105-7, 71971-9121-5, 71971-9151-5
  • Packager: Homeolab International (Canada) inc
  • 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 January 25, 2023

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

  • Active Ingredients

    Part 1 -Cough Cold Daytime Syrup

    DROSERA ROTUNDIFOLIA FLOWERING TOP
    ARNICA MONTANA
    BRYONIA ALBA WHOLE
    IPECACUANHA (IPECAC)
    CETRARIA ISLANDICA SUBSP. ISLANDICA
    COCHINEAL (COCCUS CACTI)
    CORALLIUM RUBRUM WHOLE
    STANNUM METALLICUM (TIN)

    Part 2 -Cough Cold Nighttime Syrup

    DROSERA ROTUNDIFOLIA FLOWERING TOP
    ARNICA MONTANA
    BRYONIA ALBA WHOLE
    CETRARIA ISLANDICA SUBSP. ISLANDICA
    COCHINEAL (COCCUS CACTI)
    CORALLIUM RUBRUM WHOLE
    STANNUM METALLICUM (TIN)
    CHAMOMILLA (GERMAN CHAMOMILLE)
    COFFEA CRUDA (COFFEE)

  • Purpose

    Part 1 - Cough Cold Daytime Syrup


    DROSERA ROTUNDIFOLIA FLOWERING TOP                  Dry Cough
    ARNICA MONTANA                                                              Aches and Pain , Chest Congestion
    BRYONIA ALBA WHOLE                                                       Painful Cough
    IPECACUANHA (IPECAC)                                                   Night Cough
    CETRARIA ISLANDICA SUBSP. ISLANDICA                     Cough With Expectoration
    COCHINEAL (COCCUS CACTI)                                     Cough With Expectoration
    CORALLIUM RUBRUM WHOLE                                        Painful cough
    STANNUM METALLICUM (TIN)                                       Cough, Chills and Lessen mucus

    Part 2 - Cough Cold Nighttime Syrup


    DROSERA ROTUNDIFOLIA FLOWERING TOP                        Dry Cough
    ARNICA MONTANA                                                                    Aches and Pain , Chest Congestion
    BRYONIA ALBA WHOLE                                                             Painful Cough
    CETRARIA ISLANDICA SUBSP. ISLANDICA                             Cough With Expectoration
    COCHINEAL (COCCUS CACTI)                                              Cough With Expectoration
    CORALLIUM RUBRUM WHOLE                                              Painful cough
    STANNUM METALLICUM (TIN)                                               Cough, Chills and Lessen mucus
    CHAMOMILLA (GERMAN CHAMOMILLE)                               Restlessness, irritability and nocturnal awakening
    COFFEA CRUDA (COFFEE)                                                       Restlessness and sleeplessness

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

  • Uses

    T his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with nighttime cough and cold*; dry cough, cough with expectorantion, chest congestion, aches and pain,fever.

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings

    Stop use and ask a doctor if: • Pain & cough get worse or last 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 poison control center immediately.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Part 1 Kids Relief Daytime Syrup

    Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ 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.

    Part 2 Kids Relief Nighttime Syrup

    Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 8 hours or 3 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 8 hours or 3 times a day.

  • Other information

    Part 1

    Do not use if the seal is broken or missing. Store at room temperature.

    Part 2

    Store at room temperature.• Do not use if seal is broken or missing

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

  • Inactive ingredients

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

  • Product label

    image descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    KIDS RELIEF COUGH AND COLD SYRUP COMBO PACK DAYTIME FORMULA AND NIGHTTIME FORMULA 
    drosera rotundifolia flowering top, arnica montana, bryonia alba whole, ipecacuanha, cetraria islandica subsp. islandica, cochineal, corallium rubrum whole, stannum metallicum, chamomilla, coffea cruda kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71971-6105
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71971-6105-71 in 1 KIT; Type 0: Not a Combination Product09/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 100 mL
    Part 21 BOTTLE 100 mL
    Part 1 of 2
    KIDS RELIEF 
    drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum liquid
    Product Information
    Item Code (Source)NDC:71971-9121
    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 WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE3 [hp_C]  in 100 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA WHOLE - UNII:BJ7YPN79A1) CETRARIA ISLANDICA WHOLE1 [hp_C]  in 100 mL
    COCHINEAL (UNII: TZ8Z31B35M) (COCHINEAL - UNII:TZ8Z31B35M) COCHINEAL3 [hp_C]  in 100 mL
    CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R) CORALLIUM RUBRUM WHOLE3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARAMEL (UNII: T9D99G2B1R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71971-9121-51 in 1 CARTON
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2022
    Part 2 of 2
    KIDS RELIEF 
    drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffee crudea liquid
    Product Information
    Item Code (Source)NDC:71971-9151
    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 WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE3 [hp_C]  in 100 mL
    CETRARIA ISLANDICA WHOLE (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA WHOLE - UNII:BJ7YPN79A1) CETRARIA ISLANDICA WHOLE1 [hp_C]  in 100 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 100 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE4 [hp_C]  in 100 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_C]  in 100 mL
    CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R) CORALLIUM RUBRUM WHOLE3 [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:71971-9151-51 in 1 CARTON
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2022
    Labeler - Homeolab International (Canada) inc (203639455)