Otc - Active Ingredient
Active ingredient (in each drop)
Menthol 20 mg
Cvs Menthol Medicated Throat Drops
FDA Label NDC 69842-356
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Menthol Medicated Throat Drops (NDC 69842-356). 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
Oral anesthetic
Indications & Usage
Uses temporarily relieves:
- occasional minor irritation and pain associated with sore throat and sore mouth
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. Do not use more than 2 days or administer to children under 12 years of age.
Otc - Ask Doctor
Ask a doctor before use if you have
- a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days.
- a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.
Otc - Stop Use
Stop use and consult doctor if
- sore mouth does not improve in 7 days
- irritation, pain or redness persists 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 out of reach of children.
Otc - When Using
Do not exceed recommended dosage.
Dosage & Administration
DIrections
adults and children 12 years and over - dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
children 12 years and under - do not use
Other Safety Information
Other information
- 10 calories per drop
- do not use if bag is torn or open
Inactive Ingredient
Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, glycerin, gum arabic, medium chain triglycerides, potassium sorbate, soybean oil, sucrose and water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST
* Please review the disclaimer below.
