Label: UMCKA ELDERBERRY- umcka elderberry syrup

  • NDC Code(s): 53499-5845-4, 53499-5845-7
  • Packager: Schwabe North America
  • 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 February 20, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Aconitum napellus 4x 

    Bryonia alba 4x 

    Eucalyptus globulus 2x 

    Eupatorium perfoliatum 2x 

    Gelsemium sempervirens 4x 

    Ipecacuanha 3x 

    Pelargonium sidoides 1x

    Phosphorus 6x

    Sambucus nigra 3x

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Alcohol (0.45%)

    Citric acid

    Elderberry extract

    Lactose

    Maltodextrin

    Natural Raspberry flavor

    Purified water

    Sorbitol

    Vegetable-source glycerin

    Close
  • INDICATIONS & USAGE

    Purpose:

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

    Close
  • 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.

    Close
  • WARNINGS

    Warnings:

    Sore throat warning: SEvere or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.

    Consult a doctor promptly.

    Ask a doctor before use if you have: persistent or chronic cough that lasts, is chronic 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.

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • 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

    Close
  • UMCKA Elderberry Intensive Cold + Flue Syrup

    UMCKA 15845_CF_ELDERBERRY_05.jpgUMCKA 15845_CF_ELDERBERRY_05.jpg

    Close
  • INGREDIENTS AND APPEARANCE
    UMCKA ELDERBERRY 
    umcka elderberry syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5845
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X]  in 120 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 2 [hp_X]  in 120 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]  in 120 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X]  in 120 mL
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X]  in 120 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X]  in 120 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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 10/01/2012
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:53499-5845-7 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012 09/30/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/01/2012
    Labeler - Schwabe North America (831153908)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe North America 831153908 manufacture(53499-5845)
    Close