SPL v1
SPL
SPL Set ID 2e83f15b-fa5e-4e5c-b43c-abab308205a2
Route
ORAL
Published
Effective Date 2019-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8.6 1)
Inactive Ingredients
Sucrose Corn Syrup Eucalyptus Oil D&c Yellow No. 10 Fd&c Yellow No. 6 Honey Lemon Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-07

Description

Active Ingredient (in each lozenge)  - Menthol 8.6mg


Medication Information

Warnings and Precautions

Warnings:

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These smptoms may be serious.

Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

Stop use and consult a doctor if: 

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

• sore throat is severe, or irritation, pain or redness lasts or worsens

• sore mouth does not improve in 7 days

Indications and Usage

Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat

Dosage and Administration

Directions:

• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

Children under 5 years: Consult a doctor.

Description

Active Ingredient (in each lozenge)  - Menthol 8.6mg

Section 50565-1

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose

Section 51945-4

Section 53414-9

If pregnant or breast-feeding babyask a health professional  before use. 

Section 55105-1

Cough suppressant / Oral Anesthetic

Section 55106-9

Active Ingredient (in each lozenge) - Menthol 8.6mg


Structured Label Content

Indications and Usage (34067-9)

Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions:

• Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

Children under 5 years: Consult a doctor.

Warnings and Precautions (34071-1)

Warnings:

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These smptoms may be serious.

Ask a doctor before use if you have: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

• cough accompanied by excessive phlegm (mucus)

Stop use and consult a doctor if: 

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

• sore throat is severe, or irritation, pain or redness lasts or worsens

• sore mouth does not improve in 7 days

Section 50565-1 (50565-1)

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding babyask a health professional  before use. 

Section 55105-1 (55105-1)

Cough suppressant / Oral Anesthetic

Section 55106-9 (55106-9)

Active Ingredient (in each lozenge) - Menthol 8.6mg


Advanced Ingredient Data


Raw Label Data

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