FDA Label for Menthol
View Indications, Usage & Precautions
Menthol Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient
Menthol 8.6 mg
Otc - Purpose
Purpose
Antitussive (cough suppressant)/oral anesthetic
Indications & Usage
Uses
Temporarily relieves
■ cough as may occur with a cold or inhaled irritants
■ occasional minor irritation and sore throat
Warnings
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 promptly.
These symptoms may be serious.
Otc - Stop Use
Ask a doctor if you have
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ cough accompanied by excessive phlegm (mucus)
Stop us e and ask a doctor if
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent
- sore mouth does not improve in 7 days
- irritation, pain or redness persists or worsens
headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Dosage & Administration
Directions
- do not us e more than directed
- Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.
- Do not give to children under 12 years of age.
Adults and children: (12 years and older)
Children under 12 years:
Other Safety Information
Other information
■ 15 calories per drop
■ store at 59°-86°F (15°-30°C)
■ protect from moisture & heat
Inactive Ingredient
Inactive ingredients
corn syrup, D&C yellow # 10, eucalyptus oil, FD&C yellow # 6, honey, lemon oil, sucrose
Otc - Questions
Questions? Call 1-800-777-4908
Package Label.Principal Display Panel
NDC# 68599-0465-9
McKesson
Cough Drops Assorted
Honey Lemon
250 per Jar
MFR# 27996L
* Please review the disclaimer below.