NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]

NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]
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NDC 56062-432-62, 56062-432-67, 56062-432-80
Set ID 94c21df5-c631-4748-a833-288b2298055c
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 mg

  • Purpose

    Nasal decongestant

  • Uses

    temporarily relieves sinus congestion and pressure
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 2 tablets every 4 to 6 hours
    do not take more than 8 tablets in 24 hours

    children ages 6 to 11 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

  • Other information

    each tablet contains: calcium 20 mg
    store at 20°-25°C (68°-77°F)
    do not use if blister unit is broken or torn
  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

  • Principal Display Panel

    NON-DROWSY – MAXIMUM STRENGTH

    nasal decongestant

    PSEUDOEPHEDRINE HYDROCHLORIDE 30mg

    nasal & sinus congestion

    sinus pressure + congestion

    48 TABLETS

    ACTUAL SIZE

    Compare to Active Ingredient in Sudafed® Congestion

    Publix Nasal Decongestant image
  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-432
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUND (convex) Size7mm
    FlavorImprint Code L432
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-432-672 in 1 CARTON10/12/2000
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:56062-432-804 in 1 CARTON04/18/2002
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:56062-432-621 in 1 CARTON09/09/1993
    324 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/09/1993
    Labeler - Publix Super Markets Inc (006922009)