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
Active Ingredients (In Each Extended Release Tablet)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mg
- •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.
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)
- •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.
- children under 12 years of age
- consumers with liver or kidney disease
- •store between 20° to 25°C (68° to 77°F)
- •do not use if blister unit is broken or torn
- •see side panel for lot number and expiration date
- •meets USP Dissolution Test2
colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Package/Label Principal Display Panel
Original Prescription Strength
Allergy Relief D
Cetirizine Hydrochloride, 5 mg | Pseudoephedrine Hydrochloride, 120 mg
Extended Release Tablets
Antihistamine | Nasal Decongestant
Allergy and Congestion
12-Hour Relief of:
Sneezing; Runny Nose; Sinus Pressure;
Itchy, Watery Eyes; Itchy Throat or Nose; Nasal Congestion
COMPARE TO ZYRTEC-D® active ingredients
24 EXTENDED RELEASE TABLETS
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