Label: COLD RELIEF LEMON- pelargonium sidoides powder

  • NDC Code(s): 53499-6146-0
  • 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 April 19, 2024

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

  • Active Ingredient

    Pelargonium sidoides 1X

    Inactive Ingredients

    Citric Acid

    Maltodextrin

    Natural Flavor

    Silica

    Turmeric Color

    Xylitol

  • Dosage & Administration

    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 13 years of age and older: Take 1 packet three times daily.

    Children 6-12 years of age: Take 1 packet two times daily.

    Children under 6 years of age: Consult a doctor.

    Indications & Usage

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

    Purpose

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

  • Warnings

    Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a physician promptly.

  • Ask the Doctor

    Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergey to plants of the Geraniaceae family.

  • Stop Use

    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.

  • Pregnant 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 Poison Control Center right away. 

  • PRINCIPAL DISPLAY PANEL

    LHBN15146_01_ColdRelief_LemonHotDrink_CTN_10ct_FNL.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    COLD RELIEF LEMON 
    pelargonium sidoides powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6146
    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:53499-6146-010 in 1 CARTON04/19/2024
    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(53499-6146)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProSolutions, Inc.070769782label(53499-6146) , pack(53499-6146)