UMCKA ELDERBERRY SYRUP [SCHWABE NORTH AMERICA]

UMCKA ELDERBERRY SYRUP [SCHWABE NORTH AMERICA]
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NDC 53499-9845-7
Set ID 5e2af06b-a40e-46da-b77e-ea1c09a44a45
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Pelargonium sidoides 1x

    Aconitum napellus 4x 

    Eucalyptus globulus 2x

    Sambucus nigra 3x

    Bryonia 4x 

    Eupatorium perfoliatum 6x 

    Gelsemium sempervirens 4x 

    Ipecacuanha 3x 

    Phosphorus 6x

  • Inactive Ingredients

    Citric acid

    Elderberry extract

    Ethyl Alcohol

    Glycerin

    Lactose monohydrate

    Maltodextrin

    Natural flavor

    Potassium Sorbate

    Purified water

    Sorbitol

  • INDICATIONS & USAGE

    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, sneezing, stuffy/runny nose.

  • Indications & Usage

    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, sneezing, stuffy/runny nose.

  • 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, sneezing, stuffy/runny nose.

  • Doage & Administration

    For best results, use at first sign of symptoms.

    Continue to use for an additional 48 hours after symptoms cease.

    Shake well before each use.

    Use only with enclosed dosage cup.

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

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

    Children under 6 years of age: consult a physician.

  • 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 Doctor 

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

  • Stop Use

    Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, cough lasts more then 7 days or occurs with rash or persistent headache.

    These could be signs of a serious condition.

  • Pregnancy or Breast Feeding

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

  • Keep out of reach of children

    Keep out of reach of children

  • Overdosage

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

  • PRINCIPAL DISPLAY PANEL

    15845 Umcka Elderberry Syrup.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA ELDERBERRY 
    umcka elderberry syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9845
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT4 [hp_X]  in 120 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 120 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 120 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 120 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 120 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]  in 120 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (RASPBERRY AND ELDERBERRY FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9845-71 in 1 BOX12/18/2018
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/15/2017
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9845)

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