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Drug Facts
Menthol Lozenge
FDA Label NDC 68599-0464
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Menthol (NDC 68599-0464). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
27996m (27996m)
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