FDA Label for Linkus Lozenges Cough Suppressant/oral Anesthetic

View Indications, Usage & Precautions

Linkus Lozenges Cough Suppressant/oral Anesthetic Product Label

The following document was submitted to the FDA by the labeler of this product Herbion Pakistan (pvt.) Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Menthol 5.2mg


Otc - 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.


Otc - 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


Otc - 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)

Otc - Pregnancy Or Breast Feeding



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


Otc - 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
    [email protected]
    www.herbion.com

Inactive Ingredient



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


Otc - Questions



Questions or comments:

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


Package Label.Principal Display Panel



Linkus Lozenges

Cough Suppresant Oral Anesthetic

Relieves Cough and Soothes Sore Throat

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