Label: HLU PNEUMO DROPS- arsenicum iodatum, calcarea phosphorica, carbo vegetabilis, oryctolagus cuniculus lung, phellandrium aquaticum, silicea, stannum metallicum, sulphur, thymus vulgaris 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 March 27, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:
    Arsenicum iodatum (Arsenic triiodide) 7X
    Calcarea phosphorica (Calcium phosphate) 10X
    Carbo vegetabilis (Vegetable charcoal) 12X
    Oryctolagus cuniculus (Rabbit) Lung 10X
    Phellandrium aquaticum (Water fennel) Fruit 5X
    Silicea (Silica) 12X
    Stannum metallicum (Tin) 10X
    Sulphur (Sublimed sulfur) 12X

    Thymus vulgaris (Thyme) Aerial Parts 4X

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  • PURPOSE

    Uses

    Helps promote and maintain respiratory tract health and general lung health

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  • WARNINGS

    Warnings
    Stop use and ask a doctor if 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.

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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

    Store in a cool, dry place.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol (beet), purified water

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  • DO NOT USE

    Do not use if seal is missing or broken.

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  • DOSAGE & ADMINISTRATION

    Directions
    To be taken 20 minutes away from food.

    Placedrops directly under the tongue or into ¼ oz of water.


    Adults and adolescents (12 years and older): Take 10 drops two to 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

    Helps promote and maintain respiratory tract health and general lung health.

    Directions
    To be taken 20 minutes away from food.

    Place drops directly under the tongue or into ¼ oz of water.
    Adults and adolescents (12 years and older): Take 10 drops two to 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

    62106-062662106-0626

    GENESTRA BRANDS

    NDC 62106-0626-0

    HLU

    HOMEOPATHIC PREPARATION

    To help promote and maintain
    respiratory tract health.

    Contains 31% Alcohol

    1 fl oz (30 mL)

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  • INGREDIENTS AND APPEARANCE
    HLU PNEUMO DROPS 
    arsenicum iodatum, calcarea phosphorica, carbo vegetabilis, oryctolagus cuniculus lung, phellandrium aquaticum, silicea, stannum metallicum, sulphur, thymus vulgaris liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-0626
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X]  in 30 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 10 [hp_X]  in 30 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X]  in 30 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 10 [hp_X]  in 30 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE 7 [hp_X]  in 30 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS LUNG (UNII: 857C5Q4J3H) (ORYCTOLAGUS CUNICULUS LUNG - UNII:857C5Q4J3H) ORYCTOLAGUS CUNICULUS LUNG 10 [hp_X]  in 30 mL
    OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J) OENANTHE AQUATICA FRUIT 5 [hp_X]  in 30 mL
    THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N) THYME 4 [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:62106-0626-0 1 in 1 CARTON 03/27/2016
    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 03/27/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    Name Address ID/FEI Business Operations
    Unda SA 400346069 manufacture(62106-0626)
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