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Umcka ColdCare Mint Chewable (Nature's Way Products, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, CHEWABLE 2 BLISTER PACK in 1 CARTON (53499-5145-0) > 10 TABLET, CHEWABLE in 1 BLISTER PACK Label Information

Complete Umcka ColdCare Mint Chewable Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    PELARGONIUM SIDOIDES


    Inactive Ingredients:

    MAGNESIUM STEARATE

    MALTODEXTRIN

    MANNITOL

    MODIFIED CELLULOSE GUM

    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 4-5 times daily.
    Children 6-11 years of age: take 1 chewable tablet 2-4 times daily.
    Children under 6 years of age: consult a doctor.

    Indications and Usage:

    Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections: congestion, cough, headache, hoarseness, minor aches, 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 or followed by a fever, headache, rash, nausea or vomiting, consult a doctor promptly.

    Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

    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: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

    Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

    These could be signs of a serious condition.

    Pregnancy or Breast Feeding:

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


  • UMCKA Mint Chewables (15145)

    Packaging Label. Principal Display Panel:

    15145_03 Umcka CC Mint Chew.jpg

    15145_03 Umcka CC Mint Chew.jpg


  • INGREDIENTS AND APPEARANCE
    UMCKA COLDCARE MINT CHEWABLE 
    pelargonium sidoides tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5145
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    Product Characteristics
    Color white (WHITE TABLET) Score no score
    Shape ROUND (UMCKA) Size 16mm
    Flavor MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code UMCKA;
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53499-5145-0 2 in 1 CARTON 10/11/2011 04/30/2018
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/11/2011 04/30/2018
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    Name Address ID/FEI Business Operations
    Schwabe North America, Inc. 831153908 manufacture(53499-5145)