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Sinus and Congestion Relief Daytime

Medically reviewed on Jul 21, 2017

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-663

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.

Quality Plus 44-663

Active ingredients (in each liquid-filled capsule)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses
  • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    • sinus congestion and pressure
    • fever
    • nasal congestion
    • headache
    • minor aches and pains 

Warnings

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

  • more than 4,000 mg 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:

  • 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 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
  • liver disease
  • diabetes
  • heart disease
  • thyroid 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
  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days

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
  • take only as directed
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over, 2 capsules with water every 4 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

edible white ink, FD&C yellow #6, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

Quality
  +Plus 

NDC 50844-663-02

Compare to active ingredients in Vicks® QlearQuil™ Daytime Sinus & Congestion

Sinus & Congestion Relief 

DAYTIME

Acetaminophen
Phenylephrine HCl

PAIN RELIEVER / FEVER REDUCER
NASAL DECONGESTANT

  • Nasal and Sinus Congestion
  • fever
  • Sinus Headache and Pain
  • Pseudoephedrine Free                            
  •  

 ACTUAL SIZE

12 Liquid Caps

NON-DROWSY

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

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

*This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
Vicks® QlearQuil™ Daytime Sinus & Congestion.

50844    ORG061666302

Product of China
Packaged and Quality Assured in the USA

Quality Plus 44-663

SINUS AND CONGESTION RELIEF  DAYTIME
acetaminophen, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-663
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MINERAL OIL 
POVIDONE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize21mm
FlavorImprint Code44;663
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-663-021 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:50844-663-002 BLISTER PACK in 1 CARTON
212 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:50844-663-083 BLISTER PACK in 1 CARTON
38 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2015
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(50844-663)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-663)

 
L.N.K. International, Inc.

Further information

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

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