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Drug Facts
Green Guard Honey Lemon Cough Drop Lozenge
FDA Label NDC 47682-040
14 label sections · Submitted to the FDA by Unifirst First Aid Corporation · 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 Honey Lemon Cough Drop (NDC 47682-040). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each drop)
Menthol 8.6 mg
Otc - Purpose
Purpose
Antitussive (cough suppressant)/oral anesthetic
Indications & Usage
Uses
Temporarily relieves
■ cough as may occur with a cold or inhaled irritants
■ occasional minor irritation and sore throat
Warnings
Warnings
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.
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 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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Dosage & Administration
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 2 hours as necessary or as directed by a doctor.
Children under 12 years:
Ask a doctor
Other Safety Information
Other information
■ 15 calories per drop
■ store at 59°-86°F (15°-30°C)
■ protect from moisture & heat
Inactive Ingredient
Inactive ingredients corn syrup, eucalyptus oil, D&C yellow #10, FD&C yellow #6, honey, lemon oil, sucrose
Otc - Questions
Questions or comments? 1-800-869-6970
Green Guard Honey Lemon Cough Drop Label
Green Guard®
Honey Lemon
Cough Drop relief™
Pull to Open
Tire Para Abrir
Menthol 8.6mg/Mentol 8.6mg
Cough Supressant/ Anesthetic
Suprime la tos/ anestesico
Pastillas par la tos
sabor miel y limon
Distributed by Green Guard®, St. Louis, MO 63045
50 Drops
Order #2243
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