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  5. Label Information: Leader 12 Hour Nasal Decongestant

FDA Label for Leader 12 Hour Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Leader 12 Hour Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



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 20-25°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?



    1-800-719-9260


    Principal Display Panel



    Non-Drowsy | Maximum Strength

    12-Hour Nasal Decongestant

    Pseudoephedrine Hydrochloride Extended-Release Tablets, 120 mg

    Long-Acting Nasal Decongestant | Pseudoephedrine HCl | Sinus

    Sinus Pressure

    Congestion

    10 COATED CAPLETS* 120 mg EACH

    *Capsule-shaped Tablets

    Actual Size

    COMPARE TO SUDAFED® 12 HOUR active ingredient

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    * Please review the disclaimer below.