Label: SUDAFED 24 HOUR- pseudoephedrine hydrochloride tablet, extended release 

  • Label RSS
  • NDC Code(s): 50580-669-10
  • Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

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 09/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 240 mg

    Close
  • Purpose

    Nasal decongestant

    Close
  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • reduces swelling of nasal passages
    • relieves sinus pressure
    Close
  • 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 an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • had obstruction or narrowing of the bowel. Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever
    • you experience persistent abdominal pain or vomiting

    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. (1-800-222-1222)

    Close
  • Directions

    adults and children 12 years and over
    • swallow one whole tablet with water every 24 hours
    • do not exceed one tablet in 24 hours
    • do not divide, crush, chew or dissolve the tablet
    • the tablet does not completely dissolve and may be seen in the stool (this is normal)
    children under 12 years do not use this product in children under 12 years of age
    Close
  • Other information

    • each tablet contains: sodium 10 mg
    • store at 15° to 25°C (59° to 77°F) in a dry place
    • do not use if carton is opened or if individual blister seals are broken or opened
    • see side panel for lot number and expiration date
    Close
  • Inactive ingredients

    cellulose, cellulose acetate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium chloride, and titanium dioxide

    Close
  • Questions or comments?

    call 1-888-217-2117

    Close
  • PRINCIPAL DISPLAY PANEL

    SINUS

    NDC 50580-669-10

    SUDAFED®
    24 HOUR

    PSEUDOEPHEDRINE HCl, EXTENDED RELEASE TABLETS,
    LONG-ACTING NASAL DECONGESTANT

    SINUS PRESSURE
    +CONGESTION

    Pseudoephedrine
    HCl

    MAXIMUM
    STRENGTH

    10 TABLETS
    240 MG EACH
    ‡Actual Pill Size

    NON-DROWSY

    Principal Display Panel
    Close
  • INGREDIENTS AND APPEARANCE
    SUDAFED  24 HOUR
    pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-669
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pseudoephedrine Hydrochloride (pseudoephedrine) Pseudoephedrine Hydrochloride 240 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose acetate  
    hydroxypropyl cellulose  
    hypromelloses  
    magnesium stearate  
    polyethylene glycol  
    polysorbate 80  
    povidone  
    sodium chloride  
    titanium dioxide  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code SU;24
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-669-10 2 in 1 CARTON
    1 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020021 10/01/2008
    Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
    Close