Label: UMCKA COLD FLU SUGAR FREE ORANGE- pelargonium sidoides, aconitum napellus, bryonia alba, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus syrup

  • NDC Code(s): 53499-9149-5
  • 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 26, 2018

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

  • UMCKA Cold + Flu fructose Free Orange Syrup

    Active Ingredients:

    Pelargonium sidoides 1X 

    Aconitum napellus 4X

    Eucalyptus globulus 2X

    Bryonia 4X

    Eupatoriaum perfoliatum 6X

    Gelsemium sempervirens 4X

    Phosphorus 6X

    Ipecacuanha 3X

    Inactive Ingredients:

    Citric acid

    Ethyl alcohol (0.05%)

    Glycerin

    Lactose monohydrate

    Malic acid

    Maltodextrin

    Natural orange flavor

    Purified water

    Sorbitol

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Nature's Way Brand:

    Directions: For best results, use at 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 1/2 teaspoon (7.5 mL) 3 times daily.

    Children 6-11 years of age: take 1 teaspoon (5 mL) 3 times daily.

    Children under 6 years of age: consult a physician.

    Indication and Usage:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.  

    Purpose:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose.

  • 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 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 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 than 7 days or occurs with rash or persistent headache,

    These could be signs of a serious condition.

    Keep Out of Reach of Children:

    Keep out of the reach of children.

    Overdose:

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

    Ask the 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 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 than 7 days or occurs with rash or persistent headache,

    These could be signs of a serious condition.

    OTC-Pregnancy or Breast Feeding Section:

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

  • PRINCIPAL DISPLAY PANEL

    15149_UMCKA CF_ORANGE_A01.jpg  4 oz

    15149-UMCKA CF Orange Syrup_A01.jpg

    15149-UMCKA CF Orange Syrup_A01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLD FLU SUGAR FREE ORANGE 
    pelargonium sidoides, aconitum napellus, bryonia alba, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9149
    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 NAPELLUS4 [hp_X]  in 120 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [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
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 120 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (NATURAL ORANGE FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9149-51 in 1 CARTON10/14/2017
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/14/2017
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9149)