Green Guard Advanced Sinus Relief (Acetaminophen, Phenylephrine Hydrochloride) Tablet [Unifirst First Aid Corporation] -

GREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-002-33, 47682-002-48, 47682-002-99
Set ID	7d0f777c-6115-4392-99c6-d2635d7db9ca
Category	HUMAN OTC DRUG LABEL
Packager	Unifirst First Aid Corporation
Generic Name
Product Class	alpha-1 Adrenergic Agonist
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg
PURPOSE

Purpose

Pain reliever/fever reducer

Nasal decongestant
INDICATIONS & USAGE
Uses

temporarily relieves these common cold/flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- stuffy nose
- sinus congestion and pressure
temporarily reduces fever
WARNINGS
Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- for more than 10 days unless directed by a doctor
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms appear
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away

(1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not

notice any signs or symptoms.
DOSAGE & ADMINISTRATION
Directions
- do not use more than directed
Adults and children: (12 years and older) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature 59º-86ºF (15º-30ºC)
- tamper evident sealed packets
- do not use any opened or torn packets
- avoid excessive heat and humidity
INACTIVE INGREDIENT

Inactive ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid.

*may contain

Questions or comments? 1-800-869-6970
Green Guard Advanced Sinus Relief Label

Advanced Sinus relief™

Tabletas mejoradas
para el alivio sinusal

GREEN GUARD ®

Pull to Open

Tire Para Abrir

Acetaminophen 500mg/Acetaminofeno 500 mg

Phenylephrine HCl 5mg/Fenilefrina HCl 5 mg

Pain Reliever/Fever reducer/ & Nasal Decongestant/ Alivia el dolor y reduce la fiebre y decongestivo nasal
125 Packets of 2 Tablets
250 Tablets
Order #2207
Distributed by Green Guard ®, St Louis, MO 63045

INGREDIENTS AND APPEARANCE

GREEN GUARD ADVANCED SINUS RELIEF
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR33
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-002-33	50 in 1 BOX	12/30/2008
1	NDC:47682-002-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-002-48	125 in 1 BOX	12/30/2008
2	NDC:47682-002-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-002-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

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

Labeler - Unifirst First Aid Corporation (832947092)

Name	Address	ID/FEI	Business Operations
Establishment
Prestige Packaging		080667761	relabel(47682-002) , repack(47682-002)

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Medic

GREEN GUARD ADVANCED SINUS RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]

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