NDC 50580-719 Zyrtec-d
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended R...
What is NDC 50580-719?
The NDC code 50580-719 is assigned by the FDA to the product Zyrtec-d which is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Zyrtec-d is cetirizine hydrochloride and pseudoephedrine hydrochloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 50580-719-12 2 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack, 50580-719-24 4 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Zyrtec-d?
This product is used as Active ingredients (in each extended release tablet)PurposeCetirizine HCl 5 mgAntihistaminePseudoephedrine HCl 120 mgNasal decongestant. Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatnasal congestionreduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily restores freer breathing through the nose
|Color(s)||WHITE (C48325) |
|Shape||ROUND (C48348) |
|Size(s)||10 MM |
NDC Code 50580-719-12
Package Description: 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
NDC Code 50580-719-24
Package Description: 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
What are Zyrtec-d Active Ingredients?
- CETIRIZINE HYDROCHLORIDE 5 mg/1
- PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.
Zyrtec-d Active Ingredients UNII Codes
- CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA)
- CETIRIZINE (UNII: YO7261ME24) (Active Moiety)
- PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N)
- PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1014571 - cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
- RxCUI: 1014571 - 12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
- RxCUI: 1014571 - cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet
- RxCUI: 1014583 - ZyrTEC-D Allergy & Congestion 5 MG / 120 MG 12HR Extended Release Oral Tablet
- RxCUI: 1014583 - 12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Zyrtec-D]
Zyrtec-d Inactive Ingredients UNII Codes
- 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)
* Please review the disclaimer below.
Zyrtec-d Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTC - PURPOSE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Otc - Purpose
|Active ingredients (in each extended release tablet)||Purpose|
|Cetirizine HCl 5 mg||Antihistamine|
|Pseudoephedrine HCl 120 mg||Nasal decongestant|
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- 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
- 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)
- 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|
- store between 20° to 25°C (68° to 77°F)
- do not use if blister unit is torn or broken
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
Original Prescription Strength
Pseudoephedrine HCl 120 mg/nasal decongestant
Allergy + Sinus
NASAL CONGESTION + SINUS PRESSURE
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat
* Please review the disclaimer below.