Label: ZYRTEC-D ALLERGY PLUS CONGESTION- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
- NDC Code(s): 50580-728-12, 50580-728-24, 50580-728-25
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 21, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
- Directions
- Other information
- Inactive ingredients
- 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. (878046358)