Label: DROSERA PLEX- arnica montana, belladonna, cina, coccus cacti, corallium rubrum, cuprum metallicum, drosera, ferrum phosphoricum, ipecacuanha, solidago virgaurea 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 July 6, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:

    Arnica montana (Leopard's bane) Underground Parts 6X
    Belladonna (Deadly nightshade) Whole Plant 6X (<1 x 10-8 % alkaloids, calculated)
    Cina (Wormseed) Flower-heads 6X
    Coccus cacti (Cochineal) 6X
    Corallium rubrum (Red coral) Calcareous Exoskeleton 6X
    Cuprum metallicum (Copper) 6X
    Drosera (Sundew) Whole Plant 6X
    Ferrum phosphoricum (Hydrated iron (III) phosphate) 6X
    Ipecacuanha (Ipecac) Underground Parts 6X
    Solidago virgaurea (Goldenrod) Inflorescences 2X

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  • PURPOSE

    Uses
    Assists with the temporary relief of cough.

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  • WARNINGS

    Warnings
    Ask a doctor before use if you have

    Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    Cough that is accompanied by excessive phlegm (mucus) or fever.

    Stop use and ask a doctor if

    Cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    Symptoms persist or worsen.

    If pregnant or breastfeeding, ask a health professional before use.
    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

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  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

    Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

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  • DOSAGE & ADMINISTRATION

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.

    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.
    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

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  • INDICATIONS & USAGE

    Uses
    Assists with the temporary relief of cough.

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.

    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.
    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

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  • PRINCIPAL DISPLAY PANEL

    62106-1194

    NDC 62106-1194-0

    UNDA

    plex

    DROSERA PLEX

    Homeopathic Preparation

    Assists with the temporary relief of cough.

    Contains 31% Alcohol

    1 fl oz (30 mL)

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  • INGREDIENTS AND APPEARANCE
    DROSERA PLEX 
    arnica montana, belladonna, cina, coccus cacti, corallium rubrum, cuprum metallicum, drosera, ferrum phosphoricum, ipecacuanha, solidago virgaurea liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1194
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 6 [hp_X]  in 30 mL
    ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER 6 [hp_X]  in 30 mL
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 6 [hp_X]  in 30 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 6 [hp_X]  in 30 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 2 [hp_X]  in 30 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP 6 [hp_X]  in 30 mL
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 6 [hp_X]  in 30 mL
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 6 [hp_X]  in 30 mL
    PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 6 [hp_X]  in 30 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON 6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62106-1194-0 1 in 1 CARTON 12/14/2016
    1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/14/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-1194)
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