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 (in each drop)
Menthol 7.6 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.
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)
Otc - Stop Use
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
- irritation, pain, or redness persists or worsens
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 use 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.
Adults and children: (12 years and older)
Children under 12 years:
Do not give to children under 12 years of age.
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:
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
Otc - Questions
Questions? 1-800-777-4908
Package Label.Principal Display Panel
NDC 68599-0464-9
McKesson
Cough Drops
Menthol Eucalyptus
250 per Jar
MFR# 27996M
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