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: Meijer Distribution, Inc.
Inactive Ingredients: CASTOR OIL / COLLOIDAL SILICON DIOXIDE / HYPROMELLOSES / CELLULOSE, MICROCRYSTALLINE / MAGNESIUM STEARATE / TITANIUM DIOXIDE>

Complete Information

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Pseudoephedrine HCl USP, 120 mg

  • PURPOSE

    Nasal decongestant

  • USES

    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiratory allergies
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • 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
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    When using this product
    • do not use more than directed

    • Stop use and ask a doctor if
    • symptoms do not get better within 7 days or occur with a fever
    • you get nervous, dizzy, or sleepless

    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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
    • children under 12 years: ask a doctor
  • OTHER INFORMATION

  • INACTIVE INGREDIENTS

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

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    NDC 41250-204-69

    Compare to Sudafed®12 Hour active ingredient*

    meijerâ„¢

    Non-Drowsy

    Maximum Strength

    12 Hour Decongestant

    Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP

    Long-Acting

    Nasal Decongestant

    Nasal & Sinus Congestion

    Due to Colds & Allergies

    Sinus Pressure

    10 Coated Capsule-Shaped Tablets

    120 mg Each

    DIST. BY MEIJER

    5102550/R0413

    10's blister carton label

  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-204
    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)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (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:41250-204-691 in 1 CARTON
    110 in 1 BLISTER PACK
    2NDC:41250-204-201 in 1 CARTON
    220 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07744204/28/2006
    Labeler - Meijer Distribution, Inc. (006959555)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(41250-204)