SPL v2
SPL
SPL Set ID 3fba2169-3645-4efb-87ee-15370fa01aab
Route
ORAL
Published
Effective Date 2019-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7.6 1)
Inactive Ingredients
Sucrose Corn Syrup Eucalyptus Oil Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-04-02

Description

Active Ingredient (in each lozenge)  - Menthol 7.6mg


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 symptoms 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 • occaional minor irritation and sore throat

Dosage and Administration

Directions:

• Adults and children 5 years and over: 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 7.6mg

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

artificial cherry flavor, corn syrup, eucalyptus oil, FD& C red #40, 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 7.6mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions:

• Adults and children 5 years and over: 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 symptoms 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)

artificial cherry flavor, corn syrup, eucalyptus oil, FD& C red #40, 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 7.6mg


Advanced Ingredient Data


Raw Label Data

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