Label: UMCKA COLD FLU ORANGE- pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable

  • NDC Code(s): 53499-9161-0
  • Packager: Schwabe North Amertica, 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 October 14, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES 1X

    ACONITUM NAPELLUS 4X

    BRYONIA 4X

    EUCALYPTUS GLOBULUS 2X

    EUPATORIUM PERFOLIATUM 6X

    GELSEMIUM SEMPERVIRENS 4X

    IPECACUANHA 3X

    PHOSPHORUS 6X

    Inactive Ingredients:

    CITRIC ACID

    LACTOSE MONOHYDRATE

    MAGNESIUM STEARATE

    MALIC ACID

    MANNITOL

    MALTODEXTRIN

    NATURAL FLAVOR

    STEARIC ACID

    SORBITOL

    XYLITOL

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Nature's Way Brand:

    Directions:

    Chew or dissolve tablets in the mouth.

    Do not swallow whole.

    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 chewable tablet 3 times daily.
    Children 6-11 years of age: take 1 chewable tablet 2 times daily.
    Children under 6 years of age: consult a physician.

  • INDICATIONS & USAGE

    Indications 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/stuff nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat. 

  • PURPOSE

    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/stuff nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat. 

  • WARNINGS

    Warnings:Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vimiting 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 a cough accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor 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.

  • ASK DOCTOR

    Ask the Doctor:

    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 a cough accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor 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 Reach of Children:
    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    Pregnancy or Breast Feeding:
    If pregnant or breast-feeding, ask a healthcare professional before use.

  • PRINCIPAL DISPLAY PANEL

    Umcka CF Orange-15161.jpg

    Umcka CF Orange-15161.jpg

    Umcka CF Orange-15161.jpg

    Umcka CF Orange-15161.jpg

    Umcka CF Orange-15161.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLD FLU ORANGE 
    pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9161
    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]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (C) Size16mm
    FlavorORANGE (NATURAL ORANGE FLAVOR) Imprint Code UMCKA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9161-02 in 1 CARTON09/08/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/08/2017
    Labeler - Schwabe North Amertica, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9161)