Active Ingredient(S)
Menthol 7.6 mg
Mgc Health Lozenge
FDA Label NDC 83173-113
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 83173-113). 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 1 drop slowly in the mouth. Repeat every 2 hours as needed.
■ children under 5 years: ask a doctor.
Other Information
■ 10 calories per drop ■ contains: SOY.
Inactive Ingredients
MENTHOL
ACESULFAME POTASSIUM
ASPARTAME
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
CITRIC ACID
EUCALYPTUS OIL
SUCRALOSE
ISOMALT
MALTITOL
WATER
Otc - Questions
Call 2396311907 or visit our website: www.mgc.us
Package Label - Principal Display Panel
Menthol Sugar-Free, 25 Drops NDC:83173-113-25
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