Cetirizine Hydrochloride (Allergy): Package Insert and Label Information

CETIRIZINE HYDROCHLORIDE (ALLERGY) — cetirizine hydrochloride tablet
WALGREEN CO.

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

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

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.

Ask a doctor before use if you have

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

  • 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.

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]

Directions

adults and children 6 years and over 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

  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

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

Questions?

call 1-855-274-4122

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Container Label)

ORIGINAL

PRESCRIPTION STRENGTH

Walgreens

NDC 0363-9602-09

Allergy Relief

24 HOUR ALLERGY

CETIRIZINE HYDROCHLORIDE TABLETS USP

10 mg / ANTIHISTAMINE

30 TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (30 Tablets Container Label)
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Container Carton Label)

ORIGINAL PRESCRIPTION STRENGTH

Walgreens

Compare to the active ingredient

in Zyrtec®††

NDC 0363-9602-09

Allergy Relief

24 HOUR ALLERGY

CETIRIZINE HYDROCHLORIDE TABLETS USP 10 mg / ANTIHISTAMINE

24 Hour Indoor & Outdoor Allergies

• Relief of sneezing; r unny nose; itchy,

watery eyes & itchy throat or nose

30

TABLETS 10 mg EACH ACTUAL SIZE Not ACTUAL SIZE

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (30 Tablets Container carton Label)
(click image for full-size original)

CETIRIZINE HYDROCHLORIDE (ALLERGY) cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code X;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9602-09 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (0363-9602-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090760 07/05/2021
Labeler — WALGREEN CO. (008965063)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (0363-9602), MANUFACTURE (0363-9602)

Revised: 09/2021 WALGREEN CO.

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