Label: UMCKA COLDCARE LEMON- pelargonium sidoides powder

  • NDC Code(s): 53499-5146-0
  • 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.

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES 1X

    Inactive Ingredients: citric acid, maltodextrin, natural flavor, silica, turmeric color, xylitol.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Nature's Way Brand:

    Directions:

    Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

    May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

    For best results, use at the 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 3 times daily.

    Children 6-11 years of age: take 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 irritation: congestion, cough, hoarseness, sore throat. 

    Purpose:

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

    Keep out of Reach of Children:

    Keep out of reach of children.

    Ask a 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.

    Overdosage:

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

  • PRINCIPAL DISPLAY PANEL

    Umcka Coldcare Lemon Hot Drink_01.jpgUmcka Coldcare Lemon Hot Drink_01.jpg

    Umcka Coldcare Lemon Hot Drink_01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE LEMON  
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5146
    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 5 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TURMERIC (UNII: 856YO1Z64F)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (NATURAL LEMON FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5146-010 in 1 CARTON07/01/2009
    15 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2009
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-5146)