Active Ingredient(S)
Menthol 7.5 mg
Mgc Health Cough Drops Lozenge
FDA Label NDC 83173-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medical Group Care Llc for the product Mgc Health Cough Drops (NDC 83173-101). 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(s), 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
Purposes cough suppressant, oral anesthetic
Use
- temporary 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 headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Otc - Ask Doctor
Ask a doctor before use if you have: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ 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 accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does 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 years and over: dissolve 1 drop slowly in the 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 away from excessive heat or sunlight
- do not use if primary bag seal has been torn or broke
Inactive Ingredients
corn syrup, eucalyptus oil, honey, lemon flavor, mint flavor, sucrose, sulfites (residual), turmeric (for color)
Otc - Questions
Questions or comments?
Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM - 5 PM Eastern Time or visit our website at www.mgc.us
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