Green Guard Cough Drop Relief Lozenge
FDA Label NDC 47682-018

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Green Guard Cough Drop Relief (NDC 47682-018). 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 other, active ingredient (in each drop), purpose, uses, ask a doctor before use if you have, stop use and ask a doctor if, 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

Other

Drug Facts

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Active Ingredient (In Each Drop)

Menthol 7.6 mg

Purpose

Antitussive (cough suppressant)/oral anesthetic

Uses

Temporarily relieves

  • cough as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat

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)

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. These could be signs of a serious 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

  • do not use more than directed

Adults And Children: (12 Years And Older)

Allow 1 drop to dissolve slowly in the mouth. May be repeated every hour as necessary or as directed by a doctor.

Children Under 12 Years:

Do not give to children under 12 years of age.

Other Information

  • 15 calories per drop
  • store at 59°-86°F (15°-30°C)
  • protect from moisture & heat

Inactive Ingredients:

cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

Package Label.Principal Display Panel

050B Green Guard Cough Drop Relief Label

Medicated Cherry

Cough Drop relief

Green Guard ®

Pull Out

Menthol 7.6mg

Mentol 7.6mg

125 Drops

Order #2242

Distributed by Green Guard®, St Louis, MO 63045

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