Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

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 the nose or throat

Warnings

WARNINGS SECTION

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine

Ask doctor if you have

OTC - ASK DOCTOR SECTION

• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask doctor or pharmacist before use if youare

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when drivinga motor vehicle or operating machinery

Stop use and ask doctor

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 6 years and older:
• one 10mg tablet once daily
• do not take more than one 10mg tablet in 24 hours
• a 5mg product may be appropriate for less severe symptoms
• Adults 65 years and over: ask a doctor
• Children under 6 years of age: ask a doctor
• Consumers with liver or kidney disease: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• store between 20°C to 25°C (68°F to 77°F )
• do not use if safety seal under cap is open or missing
• do not use if blister unit is broken or torn 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch, titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll free 1-888-952-0050

Manufactured for

SPL UNCLASSIFIED SECTION

A&Z Pharmaceutical, Inc.
Hauppauge, NY 11788

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

• Allergy Relief
• Cetirizine HCl 10 mg
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYDEXTROSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• STARCH, CORN
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 262 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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

Orange Book products#

Current product rows page 1 of 1 · 2 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 3 · 88 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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.