Original Extra Strength 38 Lozenges

Original Extra Strength 38 Lozenges
SPL v3
SPL
SPL Set ID acbcbc4e-e0dc-45ba-9323-680d4004adea
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

  • 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 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

  • 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 care professional before use.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomitting 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

Cough Suppressant/Oral Anesthetic

38 Lozenges

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

Distributed by: Greenwood Brands, LLC.

Buffalo-Niagara, NY 14225

[email protected]


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 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

  • 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 care 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 vomitting 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 (Inactive ingredients)

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

Principal Display Panel

FISHERMAN'S FRIEND ®

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

38 Lozenges

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

Distributed by: Greenwood Brands, LLC.

Buffalo-Niagara, NY 14225

[email protected]


Advanced Ingredient Data


Raw Label Data

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