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

  • NDC Code(s): 53499-0159-0
  • 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 October 14, 2019

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

  • Umcka Cold+ Flu Chewable Berry Tablets

    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:

    ANNATTO

    BEET JUICE

    LACTOSE MONOHYDRATE

    CARAMEL COLOR

    MAGNESIUM STEARATE

    MALIC ACID

    MALTODEXTRIN

    MANNiTOL

    SODIUM CROSCARMELLOSE

    NATURAL FLAVOR

    SORBITOL

    STEARIC ACID

    XYLITOL

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    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 and Usage:

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

    Purpose:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irriations, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy 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 a 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 reach of children.

    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 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.

    Pregnancy or Breast Feeding:

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

  • UMCKA Cold + Flu Chewable tablets15159  20 tablets

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    15159_Umcka Cold & Flu Berry_A01.jpg

    15159_Umcka Cold & Flu Berry_A01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLD FLU BERRY CHEWABLE 
    pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0159
    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
    ANNATTO (UNII: 6PQP1V1B6O)  
    BEET JUICE (UNII: IOZ32L9H3O)  
    CARAMEL (UNII: T9D99G2B1R)  
    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
    Colorpink (pink with pinkish-purple specks) Scoreno score
    ShapeROUND (C) Size16mm
    FlavorBERRY (NATURAL BERRY FLAVOR) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-0159-02 in 1 CARTON08/21/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2017
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-0159)