NDC | 50580-728-12, 50580-728-24, 50580-728-25 |
Set ID | 1e8eb279-3522-40e4-8062-06b5354f0d29 |
Category | HUMAN OTC DRUG LABEL |
Packager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | NDA021150 |
- SPL UNCLASSIFIED SECTION
- 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
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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.
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
Close - Questions?
- PRINCIPAL DISPLAY PANEL
Original Prescription Strength
NDC 50580-728-24ZYRTEC-D®
Cetirizine HCl 5 mg/antihistamine
Pseudoephedrine HCl 120 mg/nasal decongestant
Extended Release TabletsALLERGY + CONGESTION
INDOOR + OUTDOOR
ALLERGIES12
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 releaseProduct 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)