GREEN GUARD ADVANCED SINUS RELIEF- acetaminophen, phenylephrine hydrochloride tablet

Green Guard Advanced Sinus Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Pain reliever

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to

• ■ common cold
• ■ hay fever or other respiratory allergies

Temporarily

• ■ promotes nasal and/or sinus drainage; relieves sinus congestion and pressure
• ■ reduces fever

Temporarily relieves minor aches and pains associated with

• ■ headache
• ■ muscular aches
• ■ minor arthritis pain
• ■ common cold
• ■ toothache
• ■ menstrual cramps

Warnings

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

• ■ more than 8 tablets in 24 hours, which is the maximum daily amount
• ■ 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.
• ■ for more than 10 days for pain unless directed by a doctor
• ■ for more than 3 days for fever unless directed by a doctor
• ■ 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

• ■ liver disease
• ■ thyroid disease
• ■ diabetes
• ■ high blood pressure
• ■ heart disease
• ■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

• ■ taking the blood thinning drug warfarin

Stop use and ask a doctor if

• ■ symptoms do not improve within 7 days or are accompanied by a fever
• ■ pain or fever persists or gets worse
• ■ redness or swelling is present
• ■ any new symptoms appear

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

PREGNANCY OR BREAST FEEDING

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• ■ do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

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

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 ingredients

corn starch, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone*, 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 500mg

Pain Reliever & Fever reducer/ Alivia el dolor y reduce la fiebre
Phenylephrine HCl 5mg/Fenilefrina HCl 5mg
Nasal Decongestant/ Decongestivo nasal
125 Packets of 2 Tablets
250 Tablets
Order #2207
Distributed by Green Guard ®, St Louis, MO 63045

An FDA Regulated Facility

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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(47682-002) , repack(47682-002)