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: L054
Shape: C48336
Color: C48325
Ingredients: Pseudoephedrine
Size: 18.00
Score: 1
Rxtty: SY
Author: Topco Associates LLC
Inactive Ingredients: CARNAUBA WAX / SILICON DIOXIDE / CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOLS / POLYSORBATE 80 / TITANIUM DIOXIDE>

Complete Information

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 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 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
  • Inactive ingredients

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

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health

    COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR ACTIVE INGREDIENT

    NON-DROWSY

    12 Hour Decongestant

    PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 120 mg

    NASAL DECONGESTANT

    MAXIMUM STRENGTH • SINUS

    12 HOUR

    • Sinus Pressure + Congestion

    20 COATED CAPLETS*

    *CAPSULE-SHAPED TABLETS

    actual size

    054-88-12-hour-decongestant
  • INGREDIENTS AND APPEARANCE
    TOPCARE 12 HOUR DECONGESTANT 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-054
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code L054
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-054-5210 in 1 CARTON04/25/2000
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-054-6020 in 1 CARTON05/20/2003
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07515304/25/2000
    Labeler - Topco Associates LLC (006935977)
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