Careone nasal and sinus decongestant tablet, film coated

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hourstake 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours

    adults and children 12

    years and over

    children ages 6 to 11

    years

    children under 6 years

    do not use this product in children under 6 years of age

    Other information

    • each tablet contains: calcium 20 mg
    • store at 20 -25 C (68 -77 F)
    • do not use if blister unit is broken or torn.

    Inactive ingredients

    carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

    Questions or comments?

    1-800-719-9260

    Ingredients and appearance - Product information

    Careone nasal and sinus decongestant tablet, film coated- Pseudoephedrine hcl

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41520-881
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 30 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Carnauba wax ( UNII: R12CBM0EIZ)
    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)
    Silicon dioxide ( UNII: ETJ7Z6XBU4)
    Titanium dioxide ( UNII: 15FIX9V2JP)
    Fd&c red no. 40 ( UNII: WZB9127XOA)

    Product Characteristics

    Color RED Size 7 mm
    Shape ROUND (convex) Score 1
    Imprint Code L432

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    OTC monograph final part341 USA

    Labeler - American Sales Company( 809183973)

    Principal display panel

    Compare to the active ingredient in Sudafed® Congestion

    NASAL & SINUS DECONGESTANT

    Pseudoephedrine HCl Tablets, 30 mg

    Nasal Decongestant

    Maximum Strength

    Sinus Pressure

    Congestion

    Non-Drowsy

    Actual Size

    OUR PHARMACISTS RECOMMEND

    24 TABLETS

    30 mg EACH