Cough Drops

Drug Facts

Composition & Product

Active Ingredients

Menthol (5.4 mg)

Inactive Ingredients

Water Citric Acid Monohydrate Eucalyptus Oil Fd&c Blue No. 1 Corn Syrup Potassium Citrate Lecithin, Soybean Fd&c Red No. 40 Sucralose Sucrose

Identifiers & Packaging

Pill Appearance

Shape: oval Color: blue Size: 20 mm

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-29

Medication Information

Warnings and Precautions

Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.

Indications and Usage

temporarily relieves: cough due to cold, occasional minor irritation or sore throat

Dosage and Administration

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Description

Cough Drops

Section 42229-5

Cough Drops

Section 43683-2

Section 44425-7

Dry, avoid sunlight

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,

or is accompained by fever, rash, or persistent headache. These could be signs of a

serious condition. sore mouth does not improve in 7 days irritation, pain, or redness

persists or worsens.

Section 50567-7

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Section 50570-1

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

cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,

or is accompained by fever, rash, or persistent headache. These could be signs of a

serious condition. sore mouth does not improve in 7 days

irritation, pain, or redness persists or worsens.

Section 51727-6

EUCALYPTUS OIL

FD&C BLUE NO. 1

FD&C RED NO. 40

POTASSIUM CITRATE

SOY LECITHIN

SUCRALOSE

SUCROSE

GLUCOSE SYRUP

CITRIC ACID

Water

Section 51945-4

Section 55105-1

cough suppressant, oral anesthetic

Section 55106-9

Menthol

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves: cough due to cold, occasional minor irritation or sore throat

Dosage and Administration (34068-7)

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Warnings and Precautions (34071-1)

Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.

Section 42229-5 (42229-5)

Cough Drops

Section 43683-2 (43683-2)

Section 44425-7 (44425-7)

Dry, avoid sunlight

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,

or is accompained by fever, rash, or persistent headache. These could be signs of a

serious condition. sore mouth does not improve in 7 days irritation, pain, or redness

persists or worsens.

Section 50567-7 (50567-7)

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Section 50570-1 (50570-1)

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

cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur,

or is accompained by fever, rash, or persistent headache. These could be signs of a

serious condition. sore mouth does not improve in 7 days

irritation, pain, or redness persists or worsens.

Section 51727-6 (51727-6)

EUCALYPTUS OIL

FD&C BLUE NO. 1

FD&C RED NO. 40

POTASSIUM CITRATE

SOY LECITHIN

SUCRALOSE

SUCROSE

GLUCOSE SYRUP

CITRIC ACID

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

cough suppressant, oral anesthetic

Section 55106-9 (55106-9)

Menthol

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "temporarily relieves: cough due to cold, occasional minor irritation or sore throat", "34068-7": "adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed. children under 5 years: ask a doctor.", "34071-1": "Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These may be serious.", "42229-5": "Cough Drops", "44425-7": "Dry, avoid sunlight", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens.", "50567-7": "adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed. children under 5 years: ask a doctor.", "50570-1": "Ask a doctor before use if you have:persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens.", "51727-6": "EUCALYPTUS OIL FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM CITRATE SOY LECITHIN SUCRALOSE SUCROSE GLUCOSE SYRUP CITRIC ACID Water", "55105-1": "cough suppressant, oral anesthetic", "55106-9": "Menthol"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information