Label: LEADER 12 HOUR NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release

  • NDC Code(s): 70000-0475-1
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 17, 2021

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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 mg

  • Purpose

    Nasal decongestant

  • Uses

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

    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

    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

    •
    take 1 tablet every 12 hours
    •
    do not take more than 2 tablets in 24 hours

    children under 12 years

    do not use this product in children under 12 years of age
  • Other information

    •
    each tablet contains: calcium 45 mg
    •
    store at 20-25°C (68-77°F) in a dry place
    •
    protect from light
    •
    do not use if blister unit is broken or torn
    •
    see carton end panel for lot number and expiration date
    •
    this product meets the requirements of USP Drug Release Test 3
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Maximum Strength | Non-Drowsy

    12-Hour Nasal Decongestant

    Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg

    Nasal Decongestant | Sinus

    COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR MAXIMUM STRENGTH active ingredient

    Sinus Pressure + Congestion

    10 COATED CAPLETS*

    *Capsule-shaped Tablets

    Actual Size

    100% Money Back Guarantee

    054E9-12HR-nasal.jpg
  • INGREDIENTS AND APPEARANCE
    LEADER 12 HOUR NASAL DECONGESTANT 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0475-110 in 1 CARTON02/11/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515302/11/2019
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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