Active Ingredient(S)
Menthol 2.5
Mgc Health Lozenge
FDA Label NDC 83173-128
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 (NDC 83173-128). 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 cold ■ occasional minor irritation or 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. These may be serious.
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 out of reach of children.
Directions
Adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth repeat every 2 hours as needed
children under 5 years: as a doctor
Other Information
■ 10 calories per drop ■ contains: SOY.
Inactive Ingredients
beta carotene, flavors, glucose syrup, honey, soy lecithin, sucrose, water.
Otc - Questions
Call Toll-Free 866-306-9136 or visit our website: www.mac.us
Package Label - Principal Display Panel
30 Drops NDC: 83173-128-30
* Please review the disclaimer below.
