Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• 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.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	Take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg 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

STORAGE AND HANDLING SECTION

• store between 20º to 25ºC (68º to 77ºF)
• contains no ingredient made from a gluten-containing grain(wheat, barley or rye)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call  1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Zyrtec®

Allergy Relief

Cetirizine HCl Tablets USP, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of

• Sneezing 
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

Original Prescription Strength

Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Camber Consumer Care Inc, Piscataway, NJ 08854, USA

HOW SUPPLIED

How Supplied Section

Cetirizine Hydrochloride 10mg Tablets

• NDC 71335-9733-1: 30 Tablets in a BOTTLE
• NDC 71335-9733-2: 14 Tablets in a BOTTLE
• NDC 71335-9733-3: 7 Tablets in a BOTTLE
• NDC 71335-9733-4: 10 Tablets in a BOTTLE
• NDC 71335-9733-5: 15 Tablets in a BOTTLE
• NDC 71335-9733-6: 90 Tablets in a BOTTLE
• NDC 71335-9733-7: 20 Tablets in a BOTTLE
• NDC 71335-9733-8: 60 Tablets in a BOTTLE
• NDC 71335-9733-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride 10mg Tablets

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

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
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• HYPROMELLOSE, UNSPECIFIED
• TITANIUM DIOXIDE
• MICROCRYSTALLINE CELLULOSE

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

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 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

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