Home > Pill Identifier > pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Tablet

Pill Identifier Information of pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Tablet

Drug Information

pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Tablet

Imprint: 204
Shape: C48336
Color: C48325
Ingredients: Pseudoephedrine
Size: 18.00
Score: 1
Rxtty: SY
Author: CVS Pharmacy
Inactive Ingredients: CASTOR OIL / COLLOIDAL SILICON DIOXIDE / HYPROMELLOSES / CELLULOSE, MICROCRYSTALLINE / MAGNESIUM STEARATE / TITANIUM DIOXIDE>

Complete Information

  • 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 yearsdo 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: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 120 mg Caplet Blister Pack Carton

    CVSHealthâ„¢

    Compare to the active ingredient
    in Sudafed® 12 Hour†

    Non-Drowsy

    Nasal Decongestant

    PSEUDOEPHEDRINE HYDROCHLORIDE
    EXTENDED-RELEASE TABLETS, USP 120 mg
    Long-acting nasal decongestant

    MAXIMUM STRENGTH

    Relieves:

    • SINUS PRESSURE + CONGESTION

    12
    HOUR

    10 COATED CAPLETS*
    (*Capsule-Shaped Tablets, 120 mg EACH)

    Actual Size

    PRINCIPAL DISPLAY PANEL - 120 mg Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-204
    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:59779-204-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product04/28/2006
    2NDC:59779-204-2120 in 1 BLISTER PACK; Type 0: Not a Combination Product04/28/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07744204/28/2006
    Labeler - CVS Pharmacy (062312574)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(59779-204)