Active Ingredient (In Each Lozenge)
Menthol 2.5 mg
Pactin 7 mg
Menthol Cough Drops Honey Vanilla Flavor Lozenge
FDA Label NDC 10202-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 7-eleven for the product Menthol Cough Drops Honey Vanilla Flavor (NDC 10202-013). 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 active ingredient (in each lozenge), purpose, use, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pectin: oral demulcent
Menthol: cough suppressant, oral anesthetic
Use
temporarily relieves:
- Cough due to a cold
- occasional minor irritation, pain, sore mouth, and sore throat
Warnings
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or follow by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Otc - Ask Doctor
Ask a doctor before use if you have:■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ a cough accompanied by excessive phlegm (mucus).
Otc - Stop Use
Stop use and ask a doctor if:
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Directions
adults and children 2 ears and over: slowly dissolve 2 drops (one at a time in mouth). Repeat every 2 hours as needed, or as directed by a doctor
children under 2 years: ask a doctor.
Other Information
- store at room temperature
- keep awar from excessive heat or sunlight
- contains: 15 mg vitamin C per drop
- contains: 10 calories per drop
- contains: SOY.
Inactive Ingredients
ascorbic acid, beta carotene, corn syrup, honey, menthol flavor, soy lecithin, sucrose, vanilla honey flavor
Otc - Questions
Questions? Call 1-800-255-0711
Package Label - Principal Display Panel
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