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Daytime Sinus Congestion and Pain (L.N.K. International, Inc.)

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TABLET 1 BLISTER PACK in 1 CARTON (50844-466-02) > 12 TABLET in 1 BLISTER PACK Label Information

Complete Daytime Sinus Congestion and Pain Information

  • Active ingredients (in each caplet)

    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 respiratory allergies, and the common cold:
      • headache
      • sinus congestion and pressure
      • nasal congestion
      • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
    • temporarily reduces fever

  • Warnings

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

    • more than 4,000 mg in 24 hour, 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 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
    • liver disease

    • difficulty in urination due to enlargement of the prostate gland

    • heart disease

    • diabetes

    • thyroid disease

    • high blood pressure

    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 or nasal congestion gets worse or lasts more than 7 days

    • new symptoms occur

    • fever gets worse or lasts more than 3 days

    • redness or swelling is present

    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 
    • see end flap for expiration date and lot number

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C  (59°-86°F)

  • Inactive ingredients

    corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide


  • Questions or comments?

    call 1-800-426-9391


  • Principal Display Panel

    QUALITY PLUS

    NDC 50844-466-02

    *Compare to the active ingredients in Tylenol® SINUS + HEADACHE
    DAYTIME
    NON-DROWSY
    SINUS
    CONGESTION & PAIN
    Acetaminophen,
    Phenylephrine HCl

    Pain reliever/Fever reducer, Nasal decongestant

    For Relief of:
    Sinus Headache Sinus Pressure  Nasal Congestion

    12 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 + HEADACHE.
    50844       REV0316E46602

    Distributed by LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788 USA
    Quality Plus 44-466C

    Quality Plus 44-466C


  • INGREDIENTS AND APPEARANCE
    SINUS CONGESTION AND PAIN  DAYTIME
    acetaminophen and phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-466
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 17mm
    Flavor MENTHOL Imprint Code 44;466
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50844-466-02 1 in 1 CARTON 07/26/2005 08/10/2019
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/26/2005 08/10/2019
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(50844-466)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(50844-466)