Smart sense sinus 12 hour tablet, film coated, extended release

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 Parkinsons 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

take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours

    adults and children 12 years and over

    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 - 25C (68 - 77F) 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?

    1-800-719-9260

    Ingredients and appearance - Product information

    Smart sense sinus 12 hour tablet, film coated, extended release- Pseudoephedrine hcl

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49738-009
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Carnauba wax ( UNII: R12CBM0EIZ)
    Silicon dioxide ( UNII: ETJ7Z6XBU4)
    Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
    Hypromelloses ( UNII: 3NXW29V3WO)
    Magnesium stearate ( UNII: 70097M6I30)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Polyethylene glycol ( UNII: 3WJQ0SDW1A)
    Polysorbate 80 ( UNII: 6OZP39ZG8H)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color WHITE Size 18 mm
    Shape CAPSULE Score 1
    Imprint Code L054

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA075153 USA

    Labeler - Kmart Corporation( 008965873)

    Principal display panel

    COMPARE TO ACTIVE INGREDIENT IN SUDAFED® 12 HOUR CAPLETS

    ACTUAL SIZE

    non-drowsy

    sinus 12 hour

    PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg

    LONG-ACTING NASAL DECONGESTANT

    MAXIMUM STRENGTH

    12 HOUR

    SINUS PRESSURE CONGESTION

    20 COATED CAPLETS**

    120 mg EACH

    (**CAPSULE-SHAPED TABLETS)

    PSEUDOEPHEDRINE HCl