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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. OTC - PURPOSE
    16. DO NOT USE
    17. OTC - ASK DOCTOR/PHARMACIST
    18. WHEN USING THIS PRODUCT
    19. 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



SUDAFED PE® DAYTIME

Drug Facts

SUDAFED PE® NIGHTTIME

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
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
      • nasal congestion
      • temporarily relieves these symptoms due to the common cold:
        • runny nose
        • sneezing
        • nasal congestion
        • 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

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
    • 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.

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)

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
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
    • 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

carnauba wax, FD&C blue no. 1 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)

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


Otc - Purpose



Active ingredients (in each tablet)Purpose
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
  • 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.

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using This Product



  • do not exceed recommended dose
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Principal Display Panel



PREVIOUSLY SUDAFED PE® DAY + NIGHT SINUS CONGESTION
NDC 50580-239-01

SUDAFED PE®

SINUS CONGESTION

Phenylephrine HCl
Nasal Decongestant

DAYTIME

  • NASAL
    CONGESTION

    • actual size

    12 TABLETS 10 mg each

    Diphenhydramine HCl, Phenylephrine HCl
    Antihistamine, Nasal Decongestant

    NIGHTTIME

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