Original Extra Strong 2 Bags Of 20 Lozenges

Original Extra Strong 2 Bags Of 20 Lozenges
SPL v3
SPL
SPL Set ID 0089cee9-edf4-44ae-96a9-8209b9fb379b
Route
ORAL
Published
Effective Date 2010-07-28
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 2010-08-10

Description

Menthol 10 mg

Purpose

Cough suppressant/oral anesthetic


Medication Information

Purpose

Cough suppressant/oral anesthetic

Description

Menthol 10 mg

Uses

temporarily relieves

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

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.

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

Active Ingredient

Menthol 10 mg

Inactive Ingredients

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

Principal Display Panel

FISHERMAN'S FRIEND

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

2 Bags of 20 Lozenges

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

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

[email protected]


Structured Label Content

Uses

temporarily relieves

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

Purpose

Cough suppressant/oral anesthetic

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.

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

Active Ingredient (Active ingredient)

Menthol 10 mg

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

FISHERMAN'S FRIEND

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

2 Bags of 20 Lozenges

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

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

[email protected]


Advanced Ingredient Data


Raw Label Data

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