Quality Plus 44-527-Delisted

Sinus Congestion and Pain by

Drug Labeling and Warnings

Sinus Congestion and Pain by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY SEVERE- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated 
L.N.K. International, Inc.

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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Quality Plus 44-527-Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Expectorant
Nasal decongestant

Uses

  • for the temporary relief of:
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
  • temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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

  • heart disease
  • liver disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 take more than directed (see overdose warning)
  • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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, silica gel, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY PLUS

NDC: 50844-527-02

*Compare to the active ingredients in
Tylenol ® Sinus Congestion & Pain Severe

DAYTIME
NON-DROWSY

SINUS
CONGESTION & PAIN SEVERE

Acetaminophen, Guaifenesin, Phenylephrine HCl
Pain reliever/Fever reducer, Expectorant, Nasal decongestant

For Relief of:
Fever Headache Sinus Pressure Nasal Congestion Chest Congestion

12 Coated Caplets

Pseudoephedrine Free

Actual Size

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 McNeil Consumer Healthcare,
owner of the registered trademark Tylenol®
Sinus Congestion & Pain Severe.
50844                 ORG051452702

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-527

Quality Plus 44-527

SINUS CONGESTION AND PAIN  DAYTIME NON-DROWSY SEVERE
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50844-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorMINTImprint Code 44;527
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50844-527-021 in 1 CARTON08/06/200501/08/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/06/200501/08/2020
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(50844-527)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(50844-527) , PACK(50844-527)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(50844-527)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(50844-527)

Revised: 1/2020
 
L.N.K. International, Inc.