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  5. Label Information: Zyrtec-d Allergy Plus Congestion

FDA Label for Zyrtec-d Allergy Plus Congestion

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    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

Zyrtec-d Allergy Plus 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


Otc - Purpose



Active ingredients (in each extended release tablet)Purpose
Cetirizine HCl 5 mgAntihistamine
Pseudoephedrine HCl 120 mgNasal decongestant

Uses



  • 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
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose

Do Not Use



  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  • 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
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist



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


When Using This Product



  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • an allergic reaction to this product occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: 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



  • do not break or chew tablet; swallow tablet whole
    • adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
    adults 65 years and overask a doctor
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



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

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide


Questions?



call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



Original Prescription Strength
NDC 50580-728-24

ZYRTEC-D®

Cetirizine HCl 5 mg/antihistamine
Pseudoephedrine HCl 120 mg/nasal decongestant
Extended Release Tablets

ALLERGY + CONGESTION

INDOOR + OUTDOOR
ALLERGIES

12
HOUR
RELIEF OF

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