Otc - Active Ingredient
Active Ingredient:
- Menthol 7.6 mg.............cough suppresant/ oral anesthetic
Menthol Cough Drops Honey Lemon Flavor Pastille
FDA Label NDC 51316-988
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 Menthol Cough Drops Honey Lemon Flavor (NDC 51316-988). 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
Uses temporarily relieves:
- cough as may occur with a cold
- ocassional minor irritation and sore throat
Indications & Usage
Uses temporarily relieves:
cough as may occur with a cold
ocassional minor irritation and sore throat
Warnings
Warnings
Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.
Otc - Ask Doctor
Stop and consult a doctor before use if
- cough persist 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 mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.
Otc - Stop Use
Stop and consult a doctor before use if
- cough persist 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 mouth symptoms do not improve in 7 days, or if 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 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 6 years and over: dissolve 1 drop slowly in the mouth. Repeated every 2 hours as needed or as directed by a doctor.
- Children under 6 years: as a doctor
Other Safety Information
- 5 calories per drop
- May be useful for diabetics on the advice of a doctor
- Excess consumption may cause a laxative effect
- Sotre in a cool and dry place
Inactive Ingredient
citric acid, eucalyptus oil, isomalt, natural favors, stevia, turmeric (coloring)
Otc - Questions
Questions? or to report and adverse event call: 1-833-552-1767
Recent Major Changes
- Directions
- Stop and consult a doctor
- Warning
Package Label.Principal Display Panel
Back Label (Untitled)
* Please review the disclaimer below.
