Wal-Zyr D

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)	Purpose
Cetirizine HCl, USP 5 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of nose or throat
  • nasal congestion
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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) (cer tain 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

OTC - ASK DOCTOR SECTION

• 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• store between 20° to 25°C (68° to 77°F)
• do not use if carton is opened or if the blister unit is broken
• see side panel for batch number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

OTC - QUESTIONS SECTION

call toll free 1-800-818-4555 weekdays

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH
NDC 0363-0989-12

Walgreens

Compare to the active ingredients in
Zyrtec-D^® 12 Hour^††

• WALGREENS •
PHARMACIST RECOMMENDED^†

Allergy Relief D12

ALLERGY & CONGESTION
CETIRIZINE HYDROCHLORIDE 5 mg / ANTIHISTAMINE
PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg / NASAL DECONGESTANT

12 Hour
Extended-Release Tablets, USP
Indoor & Outdoor Allergies

• Relief of sneezing, itchy, watery eyes, sinus pressure, runny nose,
  itchy throat or nose & nasal congestion

12 EXTENDED-RELEASE TABLETS

ACTUAL SIZE

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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DailyMed Dashboard NDC Coverage#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

• Wal-Zyr D
• Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• PSEUDOEPHEDRINE HYDROCHLORIDE
• PSEUDOEPHEDRINE
• HYDROXYPROPYL CELLULOSE (1600000 WAMW)
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• STEARIC ACID
• TITANIUM DIOXIDE
• AMMONIA
• FERROSOFERRIC OXIDE
• ISOPROPYL ALCOHOL
• BUTYL ALCOHOL
• PROPYLENE GLYCOL
• SHELLAC
• HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.