Mgc Cough Drops Lozenge
FDA Label NDC 83173-109

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 Cough Drops (NDC 83173-109). 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 drug facts, active ingredient (in each lozenge), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Lozenge)

Menthol 5.4 mg

Purposes

Cough suppressant/oral anesthetic

Uses

temporarily 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 followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)

When using this productdo not exceed recommended dosage

Stop use and ask a doctor if
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do 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 lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 2 years of age: 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 broken.
• contains: SOY

Inactive Ingredients

acacia, citric acid, corn starch, corn syrup, eucalyptus oil, FD&C blue 1,FD&C red 40, menthol flavor, pectin, potassium citrate, soy lecithin, sucralose, sucrose, water

Questions Or Comments?

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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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