Label: NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet

  • NDC Code(s): 50844-112-08, 50844-112-22
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
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  • Warnings

    Do not use

    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 and MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • diabetes
    • high blood pressure
    • heart disease
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dose.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    adults and children
    12 years and older 
    take 2 tablets every 4 to 6 hours;
    do not take more than 8 tablets in
    24 hours 
    children ages 6 to 12 years take 1 tablet every 4 to 6 hours;
    do not take more than 4 tablets in
    24 hours 
    children under 6 years do not use this product in children
    under 6 years of age 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

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  • Questions or comments?

    1-800-426-9391 Close
  • Principal Display Panel

    NDC 50844-112-08

    *Compare to the active ingredient in Sudafed® Congestion

    Non-Drowsy / Maximum Strength
    Nasal Decongestant
    Pseudoephedrine HCl 30 mg

    Relieves:

    • Nasal & Sinus Congestion
    • Sinus Pressure

    24 Tablets

    QUALITY PLUS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
    50844        REV0712L11208

    TAMPER EVIDENT: DO NOT USE IF CARTON 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

    Quality Plus 44-112

    Qualty Plus 44-112

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  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50844-112
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code 44;112
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50844-112-22 4 in 1 CARTON
    1 12 in 1 BLISTER PACK; Combination Product Type = C112160
    2 NDC:50844-112-08 2 in 1 CARTON
    2 12 in 1 BLISTER PACK; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 08/25/1981
    Labeler - L.N.K. International, Inc. (038154464)
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