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  5. Label Information: Assured Maximum Strength Nasal Decongestant

FDA Label for Assured Maximum Strength Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    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. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL

Assured Maximum Strength Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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

Drug Facts (continued)


Active Ingredient (In Each Tablet)



Phenylephrine HCl 10 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 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 dose


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 4 hours
■ do not take more than 6 tablets in
24 hours
 children under 12 years ask a doctor


Other Information



store between 20° to 25°C (68° to 77°F)


Inactive Ingredients



croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow
#6 aluminum lake, hypromellose, lactose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, silicon dioxide,
titanium dioxide


Otc - Questions



Questions or comments? 1-888-333-9792


Principal Display Panel



ASSURED 

COMPARE TO ACTIVE INGREDIENT IN
SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves Nasal & Sinus Congestion,
Reduces Sinus Pressure, Non-Drowsy

Actual Size

PSEUDOEPHEDRINE FREE

24tablets

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion


* Please review the disclaimer below.