Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b4930fbe-452f-4f96-a2cd-768bc51c1f49
Route
ORAL
Published
Effective Date 2014-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 mg)
Inactive Ingredients
Aspartame Beta Carotene Carnauba Wax Citric Acid Monohydrate Coconut Oil Palm Kernel Oil Acacia Maltitol Sorbitol Xylitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: purple Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-01

Description

Menthol 5mg

Purpose

Cough Suppressant, Oral Anesthetic


Medication Information

Purpose

Cough Suppressant, Oral Anesthetic

Description

Menthol 5mg

Uses

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

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.

Directions

•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

•children under 5 years: ask a doctor

Product Label

Active Ingredient

Menthol 5mg

Other Information

• Phenylketonurics: Contains Phenylalanine (0.9) mg per drop. • 3.7 calories per drop

Inactive Ingredients

Aspartame (contains phenylalanine) Beta Carotene, carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol

When Using This Product

•do not exceed recommended dosage

Stop Use and Ask A Doctor If

•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.

•sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens 

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)


Structured Label Content

Uses

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

Purpose

Cough Suppressant, Oral Anesthetic

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.

Directions

•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

•children under 5 years: ask a doctor

Product Label

Active Ingredient

Menthol 5mg

Other Information

• Phenylketonurics: Contains Phenylalanine (0.9) mg per drop. • 3.7 calories per drop

Inactive Ingredients

Aspartame (contains phenylalanine) Beta Carotene, carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol

When Using This Product (When using this product)

•do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•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.

•sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens 

Ask A Doctor Before Use If You Have (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)


Advanced Ingredient Data


Raw Label Data

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