SPL v1
SPL
SPL Set ID 9c7a960f-89c5-4bf3-9dc0-2e49591079c5
Route
ORAL
Published
Effective Date 2010-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)

Identifiers & Packaging

Pill Appearance
Imprint: NONE Shape: round Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-01

Description

Menthol 5.2mg


Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and 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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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


Section 50569-3

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)

Section 51727-6

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

Section 51945-4

Linkus Lozenges

Sugar Free

Cough Suppresant Oral Anesthetic

Relieves Cough and Soothes Sore Throat

Strawberry









Section 53413-1

Questions or comments:

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

Section 53414-9

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

Section 55105-1

Cough Suppresant, Oral Anesthetic

Section 55106-9

Menthol 5.2mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Description (34089-3)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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


Section 50569-3 (50569-3)

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)

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Linkus Lozenges

Sugar Free

Cough Suppresant Oral Anesthetic

Relieves Cough and Soothes Sore Throat

Strawberry









Section 53413-1 (53413-1)

Questions or comments:

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Cough Suppresant, Oral Anesthetic

Section 55106-9 (55106-9)

Menthol 5.2mg


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Raw Label Data

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