Label: NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet, extended release

  • NDC Code(s): 70677-0001-1
  • Packager: Strategic Sourcing Services
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 1, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl, USP 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

    store at 59° to 77° F in a dry place. Protect from light
    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Inactive ingredients

    castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Distributed By McKesson
    One Post Street, San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

    sunmark®

    COMPARE TO SUDAFED® 12 HOUR
    ACTIVE INGREDIENT
    NDC 70677-0001-1

    nasal decongestant

    Pseudoephedrine Hydrochloride 120 mg
    Extended-Release Tablets, USP
    Long-Acting Nasal Decongestant

    Non-drowsy

    SINUS PRESSURE + CONGESTION
    MAXIMUM STRENGTH

    12 HOUR

    Actual Size

    10 COATED CAPSULE-SHAPED TABLETS 120 mg EACH

    PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0001
    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
    CASTOR OIL (UNII: D5340Y2I9G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 204
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-0001-11 in 1 CARTON04/05/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07744204/05/2018
    Labeler - Strategic Sourcing Services (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(70677-0001)