Otc - Active Ingredient
Active ingredient (in each drop)
Menthol 5.4 mg
Menthol Cough Drop Lozenge
FDA Label NDC 21130-265
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc. for the product Menthol Cough Drop (NDC 21130-265). 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, nausa, 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 smoking, ashtma, or emphysema
cough accompanied by excessive phlegm (mucus)
Otc - When Using
When using this product
do not exceed recommended dosage
Otc - Stop Use
Stop use and consult doctor if
cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
sore throat is severe, or irritation, pain, or redness lasts or worsens
sore mouth does not improve in 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
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 to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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