SINUS SEVERE- acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated 
L.N.K. International, Inc.

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Quality Plus 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

Warnings

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

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

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 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

Other information

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

Quality Plus

NDC 50844-572-02

*Compare to active ingredients in Tylenol® SINUS SEVERE

DAYTIME

SINUS SEVERE
Acetaminophen,
Guaifenesin, Phenylephrine HCl

PAIN RELIEVER / FEVER REDUCER
EXPECTORANT, NASAL DECONGESTANT

12 Caplets

ACTUAL SIZE
NON-DROWSY

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

50844 ORG082052702

Distributed by
LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788
USA

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

44-527C

44-527C

SINUS SEVERE 
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-572
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)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorMENTHOLImprint Code 44;527
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-572-021 in 1 CARTON03/15/2021
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 DrugM01203/15/2021
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(50844-572) , pack(50844-572)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(50844-572)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(50844-572)

Revised: 3/2023
Document Id: 63b3e2dd-d00c-4c01-980a-b394272157d0
Set id: d5c8b248-6d82-4eac-881c-0b9d0a0de8f1
Version: 4
Effective Time: 20230315
 
L.N.K. International, Inc.