Linkus Lozenges
FDA Label NDC 44237-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Herbion Pakistan (pvt.) Ltd. for the product Linkus Lozenges (NDC 44237-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Sugar Free

Cough Suppresant Oral Anesthetic

Relieves Cough and Soothes Sore Throat

Strawberry

Linkus Lozenges Strawberry Front Label (Sugarfreestrawberryfront)

Linkus Lozenges Strawberry Front Label (Sugarfreestrawberryfront)


Linkus Lozenges Strawberry Back Label (Sugarfreestrawberryback)

Linkus Lozenges Strawberry Back Label (Sugarfreestrawberryback)




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