honey lemon

honey lemon
SPL v7
SPL
SPL Set ID 87ebb4d9-78d7-1c87-e053-2a95a90adb7d
Route
oral
Published
Effective Date 2024-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (5.52 mg)
Inactive Ingredients
magnesium stearate sorbitol acesulfame citric acid acetate sucralose

Identifiers & Packaging

Pill Appearance
Shape: oval Color: white Size: 20 mm
Marketing Status
otc monograph drug completed Since 2019-05-02 Until 2024-12-31

Purpose

Cough suppressant/oral anesthetic.

Description

Active ingredient (in each lozenge) Menthol 5.52 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 occuring 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 acesulfame K, citric acid, honey lemon flavor, magnesium stearate, sorbitol, sucralose.

Description

Active ingredient (in each lozenge) Menthol 5.52 mg

Section 51945-4

FISHERMAN'S FRIEND

HONEY-LEMON

Menthol Cough Suppressant/Oral Anesthetic

SUGAR FREE

40 CT

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

Distributed by: Greenwood Brands, LLC, Buffalo-Niagra, NY 14225

[email protected]

Stop Use

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.

Ask Doctor

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.

When Using

When using this product do not use more than directed.

Active Ingredient

Active ingredient (in each lozenge)

Menthol 5.52 mg

Pregnant Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children.


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 occuring 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 acesulfame K, citric acid, honey lemon flavor, magnesium stearate, sorbitol, sucralose.

Section 51945-4 (51945-4)

FISHERMAN'S FRIEND

HONEY-LEMON

Menthol Cough Suppressant/Oral Anesthetic

SUGAR FREE

40 CT

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

Distributed by: Greenwood Brands, LLC, Buffalo-Niagra, NY 14225

[email protected]

Stop Use

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.

Ask Doctor

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.

When Using

When using this product do not use more than directed.

Active Ingredient (Active ingredient)

Active ingredient (in each lozenge)

Menthol 5.52 mg

Pregnant Or Breast Feeding (Pregnant or Breast Feeding)

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

Keep Out of Reach of Children

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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