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

  • NDC Code(s): 59779-703-52, 59779-703-60
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 2, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 mg

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  • Purpose

    Nasal decongestant

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  • Uses

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

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  • 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

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  • 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
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient in Sudafed® 12 Hour Caplets

    Non-Drowsy – Sinus

    12 Hour Nasal Decongestant

    PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg

    LONG-ACTING NASAL DECONGESTANT

    MAXIMUM STRENGTH

    PSEUDOEPHEDRINE HCl

    Sinus pressure

    Congestion

    12 HOUR

    10 COATED CAPLETS*

    *Capsule-Shaped tablets, 120 mg EACH

    Actual Size

    CVS Health 12 Hour Nasal Decongestant image
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  • INGREDIENTS AND APPEARANCE
    12 HOUR NASAL DECONGESTANT 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-703
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code L054
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-703-60 20 in 1 CARTON 09/11/2000
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:59779-703-52 10 in 1 CARTON 12/01/1999
    2 1 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
    ANDA ANDA075153 12/01/1999
    Labeler - CVS Pharmacy (062312574)
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