Label: UMCKA COUGH ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT- umcka cough syrup

  • NDC Code(s): 53499-5864-4
  • Packager: Schwabe North America, Inc.
  • 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 December 27, 2018

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Pelargonium sidoides 1X

    Aconitum napellus 3X

    Bryonia 3X 

    Hepar sulphuris calcareum 6C

    Stannum metallicum 6C

    Spongia tosta 3X

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric acid

    English ivy leaf extract

    Ethyl Alcohol (0.05%)

    Vegetable-source glycerin

    Lactose Monohydrate

    Maltodextrin

    Purified water

    Sorbitol

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  • INDICATIONS & USAGE

    Uses:

    Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose. 

    Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.

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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.

    Use only with enclosed dosage cup.

    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 (5 mL) three times daily.

    Children under 6 years of age: Consult a physician.

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  • 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 physician 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, or is accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

    These could be a sign of a serious condition.

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  • OVERDOSAGE

    Overdose:

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

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  • PREGNANCY OR BREAST FEEDING

    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:

    Keep out of reach of children.  

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  • PURPOSE

    Purpose:

    Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose.
    Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.

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  • PRINCIPAL DISPLAY PANEL

    UMCKA 15864 Cough Max Relief 4 oz15864-Umcka Cough Syrup_1.jpg

    15864-Umcka Cough Syrup_1.jpg

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  • INGREDIENTS AND APPEARANCE
    UMCKA COUGH  ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
    umcka cough syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5864
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X]  in 120 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_X]  in 120 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C]  in 120 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 6 [hp_C]  in 120 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53499-5864-4 1 in 1 BOX 10/01/2012
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/01/2012
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe North America 831153908 manufacture(53499-5864)
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