Otc - Active Ingredient
Active Ingredient in each drop Purposes
Menthol 20 mg
Severe
Menthol Caugh Suppressant
Oral Anesthetic
Menthol Vapor Cough Drops Pastille
FDA Label NDC 72628-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boston Nutraceutical Production, S.l for the product Menthol Vapor Cough Drops (NDC 72628-108). 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
Purposes
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Indications & Usage
Purposes
Temporarily relieves ocassional minor irritation and pain due to:
- sore throat
- sore mouth
Warnings
Warnings
Sore throat warning: severe or persistent throat accompanied by high fever headache, nausea and vomiting maybe serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of old.
Otc - Ask Doctor
Ask a doctor before use if you have
- A severe throat accompanied by difficulty in breathing or that last more than 2 days
- A severe throat accompanied by fever, headache, rash, swealling, nausea or vomiting.
Otc - Stop Use
Stop use and consult doctor if
- sore mouth symptons does not improve in 7 days or if irritation, pain or redness persists or worse
If pregnant or breast feeding, ask a health professional before use.
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 reach of children.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every two hours as needed or as directed by a doctor.
- Children 12 years or under do not use
Other Safety Information
Other information
- Store in a cool and dry place
Inactive Ingredient
corn syrup, sucrose, water, eucalyptus oil, acacia, FD&Blue No.1
Back Label (Product1back)
Otc - Questions
Questions or comments call: 1-888-423-0139
Package Label.Principal Display Panel
Front Label (Product1)
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