Otc - Active Ingredient
Active Ingredient (in each drop)
Menthol 7.5 mg
Menthol Cough Drop Lozenge
FDA Label NDC 30142-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Menthol Cough Drop (NDC 30142-031). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant/
Oral anesthetic
Indications & Usage
Uses temporarily relieves:
- cough as may occur with a cold
- 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, swelling, nausea, or vomiting, consult a
doctor promptly. If sore mouth symptoms do not improve
in 7 days, see your dentist or doctor promptly. These
symptoms may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with
- cough accompanied by excessive phlegm (mucus)
smoking, asthma, or emphysema
Otc - When Using
When using this product
- do not exceed recommended dosage
Otc - Stop Use
Stop use and consult a doctor if
- cough persists for more than 7 days, tends to recur,or
- sore throat is severe, or irritation, pain or redness lasts
- sore mouth does not improve in 7 days.
is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
or worsens
Otc - Pregnancy Or Breast Feeding
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 readh of
children. In case of accidental overdose, get medical help or
contact a Poison Control Center right away. (1-800-222-1222)
Dosage & Administration
Directions
adults and children 5 years and over allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
children under 5 years ask a doctor
Other Safety Information
Other information 10 calories per drop
Inactive Ingredient
Inactive ingredients: Blue flakes (FD&C blue no. 1,
glycerin, gum arabic, potassium sorbate), eucalyptus oil,
FD&C blue no. 1, FD&C red no. 40, glucose syrup,
natural flavoring, sucrose and water. Soybean oil, and
corn starch used as processing aids.
Otc - Questions
Questions or comments?
1-800-632-6900
* Please review the disclaimer below.
