Green Guard Cough Drop Relief (Menthol) Lozenge [Unifirst First Aid Corporation] -

GREEN GUARD COUGH DROP RELIEF (MENTHOL) LOZENGE [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-018-25, 47682-018-50
Set ID	0fc4cb11-8ff9-4eff-9588-c73eef4e0137
Category	HUMAN OTC DRUG LABEL
Packager	Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 7.6 mg
PURPOSE

Purpose

Anititussive (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.

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

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

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:

Do not give to children under 12 years of age.
SPL UNCLASSIFIED SECTION
Other information
- 15 calories per drop
- store at 59º-86ºF (15º-30ºC)
- protect from moisture & heat
INACTIVE INGREDIENT

Inactive ingredients

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

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

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/01/2011

Labeler - Unifirst First Aid Corporation (832947092)

Name	Address	ID/FEI	Business Operations
Establishment
Prestige Packaging		080667761	repack(47682-018) , relabel(47682-018)

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