Label: UMCKA COLDCARE MINT CHEWABLE- pelargonium sidoides tablet, chewable

  • NDC Code(s): 53499-9145-0
  • 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 March 8, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES  1X

    Inactive Ingredients:

    ETHYL ALCOHOL (0.3%)

    MAGNESIUM STEARATE

    MALTODEXTRIN

    MANNITOL

    SODIUM CROSCARMELLOSE


    NATURAL MENTHOL FLAVOR

    NATURAL SPEARMINT FLAVOR

    SORBITOL

    STEARIC ACID

    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 and Usage:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial infections: congestion, cough, hoarseness, sore throat.

    Purpose:

    Shortens duration and reduces severity of upper respiratory symptoms.

  • WARNINGS

    Warnings:

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by by high fever, headache, nausea, vomiting or rash may be serious.

    Consulta physician promptly.


    Ask a doctor before use if you have a persistent or chronic cough thats 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 get worse or last more than 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 a persistent or chronic cough thats 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 get worse or last more than 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.

  • PRINCIPAL DISPLAY PANEL

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    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

    15145-Umcka CC Mint-6.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE MINT CHEWABLE 
    pelargonium sidoides tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9145
    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]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Colorwhite (WHITE TABLET) Scoreno score
    ShapeROUND (C) Size16mm
    FlavorMENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-9145-02 in 1 CARTON12/29/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/29/2016
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-9145)