Otc - Active Ingredient
Active Ingredient (in each drop)
Menthol 5.4 mg
Menthol Cough Drop Lozenge
FDA Label NDC 37808-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heb for the product Menthol Cough Drop (NDC 37808-032). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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, consut 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 (mucas)
smoking, asthma, or emphysema
Otc - Stop Use
Stop use and ask 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. Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
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: Corn starch, corn syrup,
eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin,
gum arabic, medium chain triglycerides, natural flaovr, potassium sorbate
soybean oil, sucrose and water.
Otc - Questions
Questions? Call (888) 309-9030.
This is not manufactured or distributed by the owner of the registrated trademark HALLS ®
* Please review the disclaimer below.
