Active Ingredient(S)
Menthol 2.5 mg
Pactin 7 mg
Mgc Health Lozenge
FDA Label NDC 83698-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiamen Kang Zhongyuan Biotechnology Co., Ltd. for the product Mgc Health (NDC 83698-129). 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
Pectin: oral demulcent
Menthol: cough suppressant, oral anesthetic
Use
temporarily relieves the following symptoms associated with sore mouth and sore throat:
minor discomfort
irritated areas
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 ■ sore mouth does not improve in 7 days m, irritation, pain, or redness persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults and children 5 ears and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed
children under 5 years: ask a doctor.
Other Information
■ 15 calories per drop ■ contains: SOY.
Inactive Ingredients
beta carotene, citric acid, FD&C blue 2, FD&C red 40, flavors, glucose syrup, lactic acid, malle acid, potassium citrate, soy lecithin, sucrose, titanium dioxide,sucralose, water.
Otc - Questions
Call Toll-Free 866-306-9136 or visit our website: www.mgc.us
Package Label - Principal Display Panel
30 Drops NDC: 61658-129-30
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