Label: UMCKA ELDERBERRY - aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, pelargonium sidoides root, phosphorus and sambucus nigra flowering top syrup 

  • Label RSS
  • NDC Code(s): 53499-5845-4, 53499-5845-7
  • Packager: Nature's Way Holding Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/12

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Aconitum napellus 4x HPUS

    Bryonia alba 4x HPUS

    Eucalyptus globulus 2x HPUS

    Eupatorium perfoliatum 2x HPUS

    Gelsemium sempervirens 4x HPUS

    Ipecacuanha 3x HPUS

    Pelargonium sidoides 1x HPUS

    Phosphorus 6x HPUS

    Sambucus nigra 3x HPUS

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric acid

    Elderberry extract

    Lactose

    Maltodextrin

    Natural Raspberry flavor

    Purified water

    Sorbitol

    Vegetable-source glycerin

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  • INDICATIONS & USAGE

    Purpose:

    Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations.

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  • DOSAGE & ADMINISTRATION

    Directions:

    For best results, use at first sign of symptoms. Continue to use for an additional 48 hours after symptoms cease.

    Adults and children 12 years of age and older: take 1 1/2 teaspoons (7.5 mL) three times daily.

    Children 6 to 11 years of age: take 1 teaspoon (5mL) three times daily.

    Children under 6 years of age: consult a doctor.

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  • WARNINGS

    Warnings:

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly.

    Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more then 7 days, cough lasts more then 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days. These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a healthcare professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • PURPOSE

    Purpose:

    Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations:

    chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose

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  • PRINCIPAL DISPLAY PANEL

    15845 Umcka Elderberry



    15845 Umcka Elderberry


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  • INGREDIENTS AND APPEARANCE
    UMCKA ELDERBERRY 
    umcka elderberry syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53499-5845
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 4 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (EUCALYPTUS GLOBULUS LEAF) EUCALYPTUS GLOBULUS LEAF 2 [hp_X]  in 120 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 2 [hp_X]  in 120 mL
    GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]  in 120 mL
    IPECAC (IPECAC) IPECAC 3 [hp_X]  in 120 mL
    PELARGONIUM SIDOIDES ROOT (PELARGONIUM SIDOIDES ROOT) PELARGONIUM SIDOIDES ROOT 1 [hp_X]  in 120 mL
    PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 6 [hp_X]  in 120 mL
    SAMBUCUS NIGRA FLOWERING TOP (SAMBUCUS NIGRA FLOWERING TOP) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    EUROPEAN ELDERBERRY  
    LACTOSE  
    MALTODEXTRIN  
    WATER  
    SORBITOL  
    GLYCERIN  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BERRY (RASPBERRY AND ELDERBERRY FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53499-5845-4 1 in 1 BOX
    1 120 mL in 1 BOTTLE
    2 NDC:53499-5845-7 10 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/01/2012
    Labeler - Nature's Way Holding Co (153970520)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe North America 831153908 manufacture(53499-5845)
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