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 April 24, 2020

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric acid

    English ivy leaf extract

    Ethyl Alcohol (0.05%)

    glycerin

    Lactose Monohydrate

    Maltodextrin

    Purified water

    Sorbitol

  • 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.

  • 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 (tsp) (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.

  • 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.

  • OVERDOSAGE

    Overdose:

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

  • PREGNANCY OR BREAST FEEDING

    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:

    Keep out of reach of children.  

  • 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.

  • PRINCIPAL DISPLAY PANEL

    15864 Umcka Cough Max Relief.jpg

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5864
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 120 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 120 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 120 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 120 mL
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN6 [hp_C]  in 120 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5864-41 in 1 BOX10/01/2012
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2012
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America831153908manufacture(53499-5864)