UMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]

UMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]
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NDC 53499-5272-5, 53499-5272-9
Set ID a3d94c70-3d62-44a8-bdae-39b07e8e0e36
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    PELARGONIUM SIDOIDES 1X

  • Inactive Ingredient

    ETHYL ALCOHOL

    FRUCTOSE

    GLYCERIN

    MALTODEXTRIN

    MENTHOL

    NATURAL FLAVOR

    PURIFIED WATER

  • Dosage & Administration:

    Directions: 

    For best results, use at first sign of symptoms.

    Continue to use for an additional 48 hours after symptoms cease. 

    Use only with enclosed dosage cup.

    Adults and children 12 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.

    Children under 12 years of age: consult a physician.

  • Indications & Usage

    Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat.

  • Purpose

    Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat.

  • 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.

  • 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

    Stop use and ask the doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or 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.

  • 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 immediately. 

  • PRINCIPAL DISPLAY PANEL

    15272_Umcka Menthol Syrup_A01.jpg

  • INGREDIENTS AND APPEARANCE
    UMCKA MENTHOL 
    pelargonium sidoides syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5272
    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 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5272-51 in 1 CARTON01/01/2006
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:53499-5272-91 in 1 CARTON01/01/2006
    2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2006
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe North America, Inc831153908manufacture(53499-5272)

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