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  5. Label Information: Sudafed Pe Sinus Congestion

FDA Label for Sudafed Pe Sinus Congestion

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 OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Sudafed Pe Sinus Congestion Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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


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

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 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 yearsask a doctor

Other Information



  • store between 20-25°C (68-77°F)
  • do not use if blister unit is torn or broken

Inactive Ingredients



carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide


Questions Or Comments?



call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



PREVIOUSLY SUDAFED PE® CONGESTION
NDC 50580-437-02

SUDAFED PE®

SINUS
CONGESTION

Phenylephrine HCl, Nasal Decongestant

actual size

MAXIMUM STRENGTH

* Please review the disclaimer below.