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Severe Sinus Congestion and Pain Daytime

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC code: 33992-0527

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Assured 44-527C

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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:

  • blisters
  • rash
  • skin reddening

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • heart disease
  • thyroid disease
  • diabetes
  • liver disease
  • high blood pressure
  • 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.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED

COMPARE TO ACTIVE INGREDIENTS OF TYLENOL® SINUS SEVERE*

DAYTIME
NON-DROWSY

SEVERE
S
INUS
CONGESTION & PAIN

• Acetaminophen - Pain Reliever / Fever Reducer
• Guaifenesin - Expectorant
• Phenylephrine HCl - Nasal Decongestant

Headache, Sinus Pressure,
Nasal Congestion, Fever
& Chest Congestion

Actual Size
PSEUDOEPHEDRINE FREE

12 caplets
with Cool Blast Flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF  BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark
Tylenol® SINUS SEVERE.    

50844           REV0917H52702

ITEM# 10684

Distributed by:
Greenbrier International, Inc.
Chesapeake, VA 23320  USA

Assured 44-527C

SEVERE SINUS CONGESTION AND PAIN DAYTIME 
acetaminophen, guaifenesin and phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0527
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
CROSPOVIDONE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code44;527
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0527-21 BLISTER PACK in 1 CARTON
112 TABLET, COATED in 1 BLISTER PACK
2NDC:33992-0527-82 BLISTER PACK in 1 CARTON
212 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/06/2005
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0527)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0527)

 
GREENBRIER INTERNATIONAL, INC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.