Label: LINKUS LOZENGES COUGH SUPPRESSANT/ORAL ANESTHETIC- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 3, 2010

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  • ACTIVE INGREDIENT

    Menthol 5.2mg

  • PURPOSE

    Cough Suppresant, Oral Anesthetic

  • INDICATIONS & USAGE

    Uses:

    • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • For temporary relief of occasional minor irritation, pain, sore mouth and sore throat
  • WARNINGS

    Sore throat warning:  if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.  These may be serious.

  • STOP USE

    Stop use and ask a doctor if:

    • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persisted headache.  These could be signs of a serious condition
    • Sore throat symptoms do not improve in 7 days
    • Irritation, pain or redness persists or worsens

  • ASK DOCTOR

    Ask a doctor before use if you have:

    • A persistent or chronic cough such as occurs with smoking, asthma, emphysema
    • A cough that is accompanied by excessive phlegm (mucus)
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions


    Adults and children 12 years and over                  Take 1-2 lozenges every 2 to 3 hours not more than 8 lozenges in 24 hours

    Children 6 years to under 12 years                       Take 1 lozenge every 5 to 6 hours not more than 4 lozenges in 24 hours

    Children under 6 years of age                               Consult your doctor
  • DESCRIPTION

    Other Information:

    • store in a cool, dry place, below 25 degrees C
    • Protect from heat and light
    • Diabetic patients should not use linkus lozenges without the advice of physician and they should monitor glucose levels closely while taking lozenges as it may alter blood glucose levels

    Manufactured for:

    Herbion USA Inc.
    Williamsville NY 14221
    1-888-(OK-HERBION)-654-3724
    info.us@herbion.com
    www.herbion.com
  • INACTIVE INGREDIENT

    Ascorbic Acid, Colorants Red No. 40, Eucalyptus Oil, Hyssop, Large leaf Geiger Tree, Lesser Galangal, Licorice, Liquid Glucose, Long Pepper, Malabar Nut, Strawberry Flavor, Sugar, Sweet Violet

  • QUESTIONS

    Questions or comments:

    1-888-654-3724 Monday thru Friday, 9am-5pm or visit www.Herbion.com

  • PRINCIPAL DISPLAY PANEL

    Linkus Lozenges

    Cough Suppresant Oral Anesthetic

    Relieves Cough and Soothes Sore Throat

    Strawberry


    Linkus Lozenges Strawberry Front Label

    Linkus Lozenges Strawberry Back Label

  • INGREDIENTS AND APPEARANCE
    LINKUS LOZENGES  COUGH SUPPRESSANT/ORAL ANESTHETIC
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize17mm
    FlavorSTRAWBERRYImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44237-005-088 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2010
    Labeler - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Registrant - Herbion Pakistan (Pvt.) Ltd. (645482936)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbion Pakistan (Pvt.) Ltd.645482936relabel, manufacture
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