SINUS AND CONGESTION RELIEF DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L.N.K. INTERNATIONAL, INC.]

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  • SINUS AND CONGESTION RELIEF DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L.N.K. INTERNATIONAL, INC.]

SINUS AND CONGESTION RELIEF DAYTIME (ACETAMINOPHEN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [L.N.K. INTERNATIONAL, INC.]
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NDC 50844-663-00, 50844-663-02, 50844-663-08
Set ID e902e339-b5bc-4c5d-9861-662f739ccb12
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • 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

    Quality Plus 44-663

  • INGREDIENTS AND APPEARANCE
    SINUS AND CONGESTION RELIEF  DAYTIME
    acetaminophen, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-663
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code 663
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-663-021 in 1 CARTON03/01/2015
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50844-663-002 in 1 CARTON03/01/2015
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50844-663-083 in 1 CARTON03/01/2015
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    LNK International, Inc.832867837PACK(50844-663)
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