NEXAFED (PSEUDOEPHEDRINE HCL) TABLET [ACURA PHARMACEUTICALS, INC.]

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NEXAFED (PSEUDOEPHEDRINE HCL) TABLET [ACURA PHARMACEUTICALS, INC.]
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NDC 48964-112-24
Set ID 0881e041-ef70-4aa6-884d-1044cf86c2a2
Category HUMAN OTC DRUG LABEL
Packager Acura Pharmaceuticals, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    • for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • Warnings

    Do not exceed recommended dosage

    If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

    If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

  • DO NOT USE

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

    Do not take this product if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor
  • PREGNANCY OR BREAST FEEDING

    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.

  • Directions

    • take every 4 to 6 hours
    • do not exceed 4 doses in 24 hours
    • take tablets with enough water to ensure complete swallowing immediately after placing in the mouth

    adults and children 12 years and over

    2 tablets

    children 6 years to under 12 years

    1 tablet

    children under 6 years

    ask a doctor
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • INACTIVE INGREDIENT

    Inactive ingredients colloid silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and polyethylene oxide.

  • SPL UNCLASSIFIED SECTION

    Questions or comments?

    Please call 1-855-228-7201

    DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

  • PRINCIPAL DISPLAY PANEL

    cartonnexafed®

    PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

    NASAL DECONGESTANT

    Battle congestion. And meth abuse too.

    JOIN THE FIGHT.

    • With meth-deterring Impede ™ technology
    • Maximum strength, non-drowsy formulation
    • Relieves nasal and sinus congestion

    MANUFACTURED FOR:

    MainPointe Pharmaceuticals, LLC

    Louisville, KY 40202

    US Patent Number 10,400,699

    NDC 48964-112-24

    24

    TABLETS

  • INGREDIENTS AND APPEARANCE
    NEXAFED 
    pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48964-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 68401960MK)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite (mottled) Scoreno score
    ShapeCAPSULE (caplet-shaped) Size16mm
    FlavorImprint Code X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48964-112-242 in 1 CARTON07/10/2020
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/10/2020
    Labeler - Acura Pharmaceuticals, Inc. (001315530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Pharmaceuticals, Inc.005286822api manufacture(48964-112)
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