Label: UMCKA ALLERGY AND SINUS- pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewable

  • NDC Code(s): 53499-2194-2
  • Packager: Schwabe North American, 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 6, 2017

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

  • Active Ingredient Section

    Pelargonium sidoides 1X,

    Hydrastis canadensis 6X,

    Kali muriaticum 3X (Potassium chloride),

    Sanguinaria canadensis 6X,

    Pulsatilla 3X,

    Silicea 6X (Silicon Dioxide)

  • SPL UNCLASSIFIED SECTION

  • Inactive Ingredient Section

    Cherry Powder, 

    Citric Acid,

    Lactose monohydrate,

    Magnesium Sterate,

    Malic Acid,

    Maltodextrin,

    Mannitol,

    Natural Flavors,

    Croscarmellose Sodium,

    Sorbitol,

    Stearic acid,

    Xylitol

  • Purpose Section

    Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, headache, hoarseness, sore throat, sinus pressure, congestion, sneezing/runny nose, shrinks swollen nasal membrances, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages

  • Indications and Usage Section

    Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, headache, hoarseness, sore throat, sinus pressure, congestion, sneezing/runny nose, shrinks swollen nasal membrances, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages

  • Warnings Section

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

    Consult a physician promptly.

  • Ask a Doctor Section

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

  • Stop Use Section

    Stop use and ask a doctor is new symptoms occur, symptoms worsen or do not get better within 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 signs of a serious condition. 

  • Pregnancy or Breast Feeding Section

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

  • Keep Out of Reach of Children Section

    Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediatley. 

  • Dosage and Administration Section

    Chew or dissolve tablets in the mouth.

    Do not swallow whole.

    For best resutls, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

    Adults and children 12 years of age and older: take 1 chewable tablet 4-5 times daily.

    Children 6-11 years of age: Take 1 chewable tablet 2-4 times daily.

    Children under 6 years of age: Consult a physician. 

  • Umcka Allergy and Sinus-item# 12194 label

    12194_Umcka_Allergy_Sinus_01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA ALLERGY AND SINUS 
    pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-2194
    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]
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE6 [hp_X]
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE3 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CHERRY (UNII: BUC5I9595W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-2194-22 in 1 CARTON12/11/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/11/2017
    Labeler - Schwabe North American, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-2194)