original extra strong lozenges

original extra strong lozenges
SPL v7
SPL
SPL Set ID d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf
Route
oral
Published
Effective Date 2024-11-07
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 drug active Since 2010-08-10 Until 2024-01-01

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 10 mg


Medication Information

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor.

Uses

temporarily relieves

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

Cough suppressant/oral anesthetic

Directions

  • adults and children 2 years of age and over: allow 1 lozenge to dissolve slowly in the mouth
  • repeat every 2 hours as needed or as directed by a doctor
  • children under 2 years of age: ask a doctor

Inactive Ingredients

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

Description

Menthol 10 mg

Section 42229-5

FISHERMAN'S FRIEND ®

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

Cough Suppresant/Oral Anesthetic

Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England

Distributed by: Greenwood Brands, LLC. Buffalo-Niagara, NY 14225

[email protected]

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
Section 50567-7

When using this product

do not use more than directed

Section 50569-3

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough that lasts such as occurs with smoking, asthma, or emphysema
Section 53414-9

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

01 Label

02 Label

03 Label

05 Label

Active Ingredient

Menthol 10 mg


Structured Label Content

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor.

Uses

temporarily relieves

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

Cough suppressant/oral anesthetic

Directions

  • adults and children 2 years of age and over: allow 1 lozenge to dissolve slowly in the mouth
  • repeat every 2 hours as needed or as directed by a doctor
  • children under 2 years of age: ask a doctor

Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

FISHERMAN'S FRIEND ®

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

Cough Suppresant/Oral Anesthetic

Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England

Distributed by: Greenwood Brands, LLC. Buffalo-Niagara, NY 14225

[email protected]

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
Section 50567-7 (50567-7)

When using this product

do not use more than directed

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough that lasts such as occurs with smoking, asthma, or emphysema
Section 53414-9 (53414-9)

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

01 Label (01 label)

02 Label (02 label)

03 Label (03 label)

05 Label (05 label)

Active Ingredient (Active ingredient)

Menthol 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)