Label: UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid

  • NDC Code(s): 53499-5271-4, 53499-5271-8
  • 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 September 13, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES 1x

    Inactive Ingredients:  Citric acid, ethyl alcohol, glycerin, maltodextrin, potassium sorbate, purified water, sorbitol.

  • DOSAGE & ADMINISTRATION

    Nature's Way Brand:

    Directions: 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 1.5 mL 3 times daily by mouth.

    Children 6-11 years of age: take 1 mL 3 times daily by mouth.

    Children under 6 years of age: consult a physician.

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

    OTC Purpose: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, 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, vomiting or rash may be serions.

    Consult a physician promptly.

    Keep out of the reach of children.

    ASK 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 emphysema or is accompanied by excessive phlegm (mucus). 


    Stop use and ask a doctor if new symptoms occur, symptoms get 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.

    OVERDOSE WARNING:

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

    OTC  Pregnancy or Breast Feeding

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE ALCOHOL-FREE 
    pelargonium sidoides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5271
    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 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5271-41 in 1 CARTON02/02/2009
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:53499-5271-81 in 1 CARTON02/02/2009
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/02/2009
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc.831153908manufacture(53499-5271)