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Zyrtec-D 12 Hour: Package Insert / Prescribing Info

Package insert / product label
Generic name: cetirizine hydrochloride and pseudoephedrine hydrochloride
Dosage form: tablet, extended release
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Nov 13, 2024.

Drug Facts

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

Indications and Usage for Zyrtec-D 12 Hour

  • 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)

Zyrtec-D 12 Hour Dosage and Administration

  • 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

Storage and Handling

  • 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

Principal Display Panel
ZYRTEC-D ALLERGY PLUS CONGESTION
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-728
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to off white) Scoreno score
ShapeROUND (Biconvex) Size10mm
FlavorImprint CodeZyrtec;D
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-728-122 in 1 CARTON01/01/2008
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-728-244 in 1 CARTON01/01/2008
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-728-254 in 1 CARTON01/01/2008
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02115001/01/2008
Labeler - Kenvue Brands LLC (118772437)
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