LINKUS LOZENGES COUGH SUPPRESSANT/ORAL ANESTHETIC- menthol lozenge

Linkus Lozenges by

Drug Labeling and Warnings

Linkus Lozenges by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Cherry

INGREDIENTS AND APPEARANCE

LINKUS LOZENGES  COUGH SUPPRESSANT/ORAL ANESTHETIC
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	17mm
Flavor	CHERRY	Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-003-08	8 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2010

Labeler - Herbion Pakistan (Pvt.) Ltd. (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd. (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd.		645482936	relabel, manufacture