GREEN GUARD ADVANCED SINUS RELIEF- acetaminophen, phenylephrine hydrochloride tablet 
Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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819R Green Guard Advanced Sinus Relief

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

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

These could be signs of a serious condition.

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

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.

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

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, 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 500mg

Phenylephrine HCl 5mg/Fenilefrina HCl 5mg

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

Green Guard

GREEN GUARD ADVANCED SINUS RELIEF 
acetaminophen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (UNII: 68401960MK)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code AZ;261
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-001-3350 in 1 BOX12/30/2008
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:47682-001-48125 in 1 BOX12/30/2008
2NDC:47682-001-992 in 1 PACKET; Type 0: Not a Combination Product
3NDC:47682-001-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2008
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 3/2022
 
Unifirst First Aid Corporation