UMCKA FASTACTIVES BERRY (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) POWDER [SCHWABE NORTH

UMCKA FASTACTIVES BERRY (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) POWDER [SCHWABE NORTH
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NDC 53499-9349-0
Set ID 149941fb-9b5f-42f2-bf0c-e5980f7daad6
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    PELARGONIUM SIDOIDES 1X

    ACONITUM NAPELLUS  4X

    EUCALYPTUS GLOBULUS 2X

    BRYONIA 4X

    EUPATORIUM PERFOLIATUM  6X

    GELSEMIUM SEMPERVIRENS 4X

    PHOSPHORUS 6X

    IPECACUANHA 3X

    Inactive Ingredients

    CITRIC ACID

    ETHYL ALCOHOL

    LACTOSE MONOHYDRATE
    MALIC ACID
    MALTODEXTRIN
    NATURAL FLAVOR
    SILICA
    XYLITOL

  • Dosage & Administration

    Tear packet open, pour contents into mouth and swallow.  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 contents of 1 packet 3 times daily.
    Children 6-11 years of age: Take contents of 1 packet 2 times daily.
    Children under 6 years of age: consult a physician.

    Indications & Usage

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

    Purpose

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

  • Warnings

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

    Consult a physician promptly.

  • Ask A 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 emphysemsa, or is accompanied by excessitve phlegm (mucus)

  • Stop Use

    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 headaches. These could be signs of a serious condition. 

  • 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.

  • Overdose

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

  • PRINCIPAL DISPLAY PANEL

    15349_A01-Umcka CF Berry Fastactives.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA FASTACTIVES BERRY 
    pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9349
    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 912 mg
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]  in 912 mg
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]  in 912 mg
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]  in 912 mg
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 912 mg
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 912 mg
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 912 mg
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]  in 912 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (NATURAL BERRY FLAVORS) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9349-010 in 1 CARTON04/14/2017
    1912 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/14/2017
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-9349)

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