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Maximum Strength Suphedrine (CHAIN DRUG MARKETING ASSOCIATION INC)

Available Formats

Dosage Form Package Information Links
TABLET 1 BLISTER PACK in 1 CARTON (63868-146-50) > 50 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BLISTER PACK in 1 CARTON (63868-146-24) > 24 TABLET in 1 BLISTER PACK Label Information

Complete Maximum Strength Suphedrine Information

  • Active ingredient  (in each tablet)

    Pseudoephedrine HCl 30 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 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
    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dose.

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with 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.


  • Directions

    adults and children
    12 years and older 
    take 2 tablets every 4 to 6 hours;
    do not take more than 8 tablets in
    24 hours 
    children ages
    6 to 12 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

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number

  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin


  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00PM ET, Monday-Friday


  • Principal Display Panel

    NDC 63868-146-48

    *Compare to the
    active ingredient in
    SUDAFED® CONGESTION

    QC
    QUALITY
    CHOICE®

    Maximum Strength
    Suphedrine
    Nasal Decongestant
    Pseudoephedrine HCl 30 mg | Non-Drowsy

    Nasal & Sinus Congestion
    Sinus Pressure

    48 Tablets (30 mg Each)

    TAMPER EVIDENT: DO NOT USE IF CARTON IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by
    McNeil Consumer Healthcare, owner of the registered
    trademark Sudafed® Congestion.
    50844      REV0712A11222

    ©Distributed by C.D.M.A., Inc.
    43157 W. Nine Mile
    Novi, MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300

    Quality Choice 44-112

    Quality Choice 44-112


  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE  MAXIMUM STRENGTH
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-146
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code 44;112
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-146-24 1 in 1 CARTON 08/25/1981 02/22/2020
    1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:63868-146-50 1 in 1 CARTON 08/25/1981 11/22/2016
    2 50 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:63868-146-22 2 in 1 CARTON 08/25/1981 11/22/2016
    3 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:63868-146-48 2 in 1 CARTON 08/25/1981 02/22/2020
    4 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 08/25/1981 02/22/2020
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63868-146)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63868-146)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(63868-146)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(63868-146)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(63868-146)