SUDAFED 24 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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  • SUDAFED 24 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

SUDAFED 24 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-669-10
Set ID 9991599a-b49b-4ea6-a6e1-c05f0c992f71
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number NDA020021
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 240 mg

  • Purpose

    Nasal decongestant

  • 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
  • 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)

  • 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 yearsdo not use this product in children under 12 years of age
  • 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
  • Inactive ingredients

    cellulose triacetate, hydroxypropylcellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, shellac, sodium chloride, and titanium dioxide

  • Questions or comments?

    call 1-888-217-2117

  • 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
  • INGREDIENTS AND APPEARANCE
    SUDAFED  24 HOUR
    pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-669
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride240 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    sodium chloride (UNII: 451W47IQ8X)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code SU;24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-669-102 in 1 CARTON10/01/2008
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02002110/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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