Label: PSEUDOEPHEDRINE HCL tablet, extended release

  • NDC Code(s): 58602-804-67, 58602-804-83
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 3, 2022

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  • 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

    • Each tablet contains: calcium 36 mg
    • store at 20° to 25°C (68° to 77°F). Protect from light.
    • do not use if the individual blister unit is open or torn
    • see side panel for lot number and expiration date
    • Meets USP dissolution test 4
  • Inactive ingredients

    colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

  • Questions or comments?

    call 1-855-274-4122
    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India
    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

    AUROHEALTH
    Compare to the active ingredient in
    Sudafed® 12 Hour** 
    NDC 58602-804-67
    MAXIMUM STRENGTH
    Long-Acting Nasal Decongestant
    Pseudoephedrine HCl
    Extended-Release Tablets USP 120 mg
    •  SINUS PRESSURE
    •  CONGESTION
    •  NON-DROWSY
    12 HOUR
    20 COATED CAPLETS*
    120 mg EACH
    *CAPSULE-SHAPED TABLETS


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HCL 
    pseudoephedrine hcl tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-804
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 70;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-804-831 in 1 CARTON06/09/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-804-672 in 1 CARTON06/09/2017
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20900806/09/2017
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-804) , MANUFACTURE(58602-804)
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