GREEN GUARD COUGH DROP RELIEF- menthol lozenge

Green Guard Cough Drop Relief by

Drug Labeling and Warnings

Green Guard Cough Drop Relief by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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.

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)

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

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

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:

Do not give to children under 12 years of age.

Other information

• 15 calories per drop
• store at 59º-86ºF (15º-30ºC)
• protect from moisture & heat

Inactive ingredients:

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

Questions or comments?

1-800-869-6970

Green Guard Cough Drop Label

Green Guard Cough Drop Relief Label

Medicated Cherry

Cough Drop relief

Green Guard ®

Pull To Open

Tire Para Abrir

Menthol 7.6mg

Mentol 7.6mg

Cough Supressant/Anethetic

Suprime la tos/anestesico

125 Drops

Order #2242

Distributed by Green Guard®, St Louis, MO 63045

An FDA Regulated Facility

INGREDIENTS AND APPEARANCE

GREEN GUARD COUGH DROP RELIEF 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.6 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red (red)	Score	no score
Shape	OVAL (OVAL)	Size	22mm
Flavor	CHERRY (Cherry)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-018-50	50 in 1 BOX; Type 0: Not a Combination Product	11/01/2011
2	NDC: 47682-018-25	125 in 1 BOX; Type 0: Not a Combination Product	11/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2011

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Green Guard First Aid & Safety		176528040	repack(47682-018) , relabel(47682-018)