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  5. Label Information: 12 Hour Nasal Decongestant

FDA Label for 12 Hour Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 120 MG TABLET BLISTER PACK CARTON

12 Hour Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Other



Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017


Active Ingredient (In Each Tablet)



Pseudoephedrine HCl, USP 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

Otc - Do Not Use



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

Otc - When Using



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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 yearsdo not use this product in children under 12 years of age

Other Information



  • store at 59° to 77° F in a dry place. Protect from light
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients



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


Questions?



call 1-800-406-7984


Principal Display Panel - 120 Mg Tablet Blister Pack Carton



LEADER™

NDC 70000-0656-1

Maximum Strength | Non-Drowsy

12-Hour
Nasal Decongestant

Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg
Nasal Decongestant

Sinus Pressure + Congestion

10
COATED
CAPLETS*

*Capsule-shaped Tablets

Actual Size

COMPARE TO
SUDAFED® SINUS
CONGESTION 12 HOUR**
active ingredient

100% Money Back Guarantee

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton - nasal 01

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton - nasal 01


* Please review the disclaimer below.