Thoracol

Thoracol
SPL v3
SPL
SPL Set ID ccbd5daf-29df-42ad-8108-98177250ec74
Route
ORAL
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (9 mg)
Inactive Ingredients
Beta Carotene Corn Syrup Eucalyptus Oil Honey Lecithin, Soybean Sucrose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-09

Description

Active ingredient (in each lozenge) Menthol 9 mg


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, nausea, or vomiting, consult a doctor right away

Indications and Usage

Uses

Temporarily relieves sore throat and cough occurring with a cold

Dosage and Administration

Directions

Do not take more than directed

Adults and children 12 years of age and over: 

  • allow one lozenge to dissolve slowly in mouth
  • may be repeated every 2 hours as needed or as directed by a doctor

Children under 12 years of age: ask a doctor

Description

Active ingredient (in each lozenge) Menthol 9 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if:

  • sore mouth does improve in 7 days
  • irritation, pain or redness persists or worsens
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache

These could be signs of a serious condition

Section 50569-3

Ask a doctor before use if you have

  • a cough acccompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Section 51727-6

Inactive ingredients

beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose, water

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant/oral anesthetic

Section 55106-9

Active ingredient (in each lozenge)

Menthol 9 mg

Section 60561-8

Other information

  • Contains: SOY
  • 12 calories per drop
  • store at 59° to 86°F (15°-30°C) in a dry place
  • avoid excessive heat and humidity

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves sore throat and cough occurring with a cold

Dosage and Administration (34068-7)

Directions

Do not take more than directed

Adults and children 12 years of age and over: 

  • allow one lozenge to dissolve slowly in mouth
  • may be repeated every 2 hours as needed or as directed by a doctor

Children under 12 years of age: ask 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, nausea, or vomiting, consult a doctor right away

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • sore mouth does improve in 7 days
  • irritation, pain or redness persists or worsens
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache

These could be signs of a serious condition

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a cough acccompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Section 51727-6 (51727-6)

Inactive ingredients

beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose, water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant/oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each lozenge)

Menthol 9 mg

Section 60561-8 (60561-8)

Other information

  • Contains: SOY
  • 12 calories per drop
  • store at 59° to 86°F (15°-30°C) in a dry place
  • avoid excessive heat and humidity

Advanced Ingredient Data


Raw Label Data

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