GREEN GUARD ALLERGY 2 RELIEF- phenylephrine hydrochloride tablet, film coated

Green Guard Allergy 2 Relief by

Drug Labeling and Warnings

Green Guard Allergy 2 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 tablet)

Phenylephrine HCl 5mg

Purpose

Nasal decongestant

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage

Warnings

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product

■ do not exceed recommended dosage

Stop use and ask a doctor if

■ you get nervous, dizzy, or sleepless

■ symptoms do not improve within 7 days or are accompanied by fever

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

• read all product information before using.
• store at room temperature 59º-86º F (15º-30º C).
• tamper evident sealed packets.
• do not use any opened or torn packets

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Questions or comments?

1-800-869-6970

Green Guard Allergy 2 Relief Label

Allergy 2 relief™
Pull To Open

Tire Para Abrirull
Phenylephrine HCl 5mg
Hidrocloruro de Fenilefrina 5mg
Tabletas para el alivio de
sintomas alergicos
Temporarily relieves nasal congestion due
to common cold, hay fever and other

upper respiratory allergies.
Green Guard®
50 Packets of 2 Tablets
100 Tablets
Order #2230
Distributed by Green Guard®, St Louis, MO 63045

An FDA Regulated Facility

INGREDIENTS AND APPEARANCE

GREEN GUARD ALLERGY 2 RELIEF 
phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (red)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	271
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-017-33	100 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-017-48	250 in 1 BOX	12/30/2008
2	NDC: 47682-017-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-017-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-017) , repack(47682-017)