ZYRTEC-D ALLERGY PLUS CONGESTION- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

ZYRTEC-D by

Drug Labeling and Warnings

ZYRTEC-D by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each extended release tablet)	Purpose
Cetirizine HCl 5 mg	Antihistamine
Pseudoephedrine HCl 120 mg	Nasal 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

Warnings

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.

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

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

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 over: take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
• adults 65 years and over: ask a doctor
• children under 12 years of age: ask a doctor
• consumers with liver or kidney disease: ask 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

• Sneezing
• Itchy, Watery Eyes
• Runny Nose
• Itchy Throat or Nose
• Sinus Pressure
• Nasal Congestion

(Actual Size)

24
EXTENDED
RELEASE TABLETS

INGREDIENTS AND APPEARANCE

ZYRTEC-D  ALLERGY PLUS CONGESTION
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-728
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	5 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	120 mg

Inactive Ingredients
Ingredient Name	Strength
silicon dioxide (UNII: ETJ7Z6XBU4)
croscarmellose sodium (UNII: M28OL1HH48)
hypromellose, unspecified (UNII: 3NXW29V3WO)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to off white)	Score	no score
Shape	ROUND (Biconvex)	Size	10mm
Flavor		Imprint Code	Zyrtec;D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-728-12	2 in 1 CARTON	01/01/2008
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-728-24	4 in 1 CARTON	01/01/2008
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-728-25	4 in 1 CARTON	01/01/2008
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021150	01/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)