064-05

064-05
SPL v4
SPL
SPL Set ID 2299916d-9864-4176-bc77-fa35a0ed959b
Route
ORAL
Published
Effective Date 2010-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 mg)
Inactive Ingredients
Capsicum Eucalyptus Oil Licorice Raw Sugar Tragacanth

Identifiers & Packaging

Pill Appearance
Shape: oval Color: brown Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-09-08

Description

Menthol 10 mg

Purpose

Cough suppressant/oral anesthetic


Medication Information

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 10 mg

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
  • occasional minor sore throat

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not use more than directed

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist of doctor promptly.

Directions


  • adults and children 2 to under 12 years of age: allow lozenge to dissolve slowly in the mouth
  • may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor
  • children under 2 years of age: consult a doctor

Inactive Ingredients

capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

Principal Display Panel

Original

Extra

Strong

Trial Size

Since Lofthouse's 1865

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

No Artificial Flavors or Ingredients

2 Lozenges

Manufactured by:

Lofthouse of Fleetwood Ltd., Lancs., England

Distributed by: Pez Candy Inc.

35 Prindle Hill Road, Orange, CT 06477

www.fishermansfriend.com

Active Ingredient (in Each Lozenge)

Menthol 10 mg


Structured Label Content

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
  • occasional minor sore throat

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Purpose

Cough suppressant/oral anesthetic

Warnings

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist of doctor promptly.

Directions


  • adults and children 2 to under 12 years of age: allow lozenge to dissolve slowly in the mouth
  • may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor
  • children under 2 years of age: consult a doctor

Inactive Ingredients (Inactive ingredients)

capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

Principal Display Panel

Original

Extra

Strong

Trial Size

Since Lofthouse's 1865

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

No Artificial Flavors or Ingredients

2 Lozenges

Manufactured by:

Lofthouse of Fleetwood Ltd., Lancs., England

Distributed by: Pez Candy Inc.

35 Prindle Hill Road, Orange, CT 06477

www.fishermansfriend.com

Active Ingredient (in Each Lozenge) (Active ingredient (in each lozenge))

Menthol 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)