Thieves Menthol Cough Drop

Thieves Menthol Cough Drop
SPL v1
SPL
SPL Set ID 99e82a7e-09c7-0a52-e053-2995a90ab7dd
Route
ORAL
Published
Effective Date 2020-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 mg)
Inactive Ingredients
Lemon Oil Stevia Leaf Isomalt Pectin Peppermint Rosemary Oil Cinnamon Bark Oil Clove Oil Eucalyptus Radiata Leaf Oil

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: oval Color: red Size: 22 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-12-17

Description

Menthol 8mg


Medication Information

Warnings and Precautions

Sore Throat Warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, or vomiting, consult a doctor promptly. These symptoms may be serious.

Indications and Usage

Temporarily relieves:

- cough due to a cold

- occasional minor irritation or sore throat

Dosage and Administration

- Adults and children 5 years of age: dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed.

- Children under 5 years of age: ask a doctor

Description

Menthol 8mg

Section 50565-1

Keep out of reach of children.

Section 50566-9

- cough persists for more than 1 seek, tends to recur, or is accompanied 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 50568-5

- persistent or chronic cough such as occurs with smoking, asthma or emphysema

- cough accompanied by excessive phlegm (mucus)

Section 51727-6

cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

Section 51945-4

Section 53414-9

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

Section 55105-1

Cough Suppressant / Oral Anesthetic

Section 55106-9

Menthol 8mg

Section 60561-8

- store at room temperature. Keep out of direct sunlight.

- 5 calories per drop


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves:

- cough due to a cold

- occasional minor irritation or sore throat

Dosage and Administration (34068-7)

- Adults and children 5 years of age: dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed.

- Children under 5 years of age: ask a doctor

Warnings and Precautions (34071-1)

Sore Throat Warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, or vomiting, consult a doctor promptly. These symptoms may be serious.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

- cough persists for more than 1 seek, tends to recur, or is accompanied 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 50568-5 (50568-5)

- persistent or chronic cough such as occurs with smoking, asthma or emphysema

- cough accompanied by excessive phlegm (mucus)

Section 51727-6 (51727-6)

cinnamon bark oil, clove bud oil, eucalyptus radiata leaf oil, isomalt, lemon peel oil, pectin, peppermint aerial parts oil, rosemary leaf oil, stevia leaf extract, water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Cough Suppressant / Oral Anesthetic

Section 55106-9 (55106-9)

Menthol 8mg

Section 60561-8 (60561-8)

- store at room temperature. Keep out of direct sunlight.

- 5 calories per drop


Advanced Ingredient Data


Raw Label Data

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