Cetirizine: Package Insert and Label Information

CETIRIZINE- cetirizine hydrochloride capsule, liquid filled
Walgreens

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Active ingredient (in each capsule)

Cetirizine HCl 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 capsule once daily; do not take more than one 10 mg capsule 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 at 20° to 25°C (68° to 77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

butylated hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

call 1-800-706-5575 Monday to Friday 9 AM to 5 PM EST

Principal Display Panel

24 Hour Allergy Relief Liquid Gels

Cetirizine HCl Capsules 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour
Relief of:

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

Walgreens

Carton-25s.jpg
(click image for full-size original)

Principal Display Panel

24 Hour Allergy Relief Liquid Gels

Cetirizine HCl Capsules 10 mg

Antihistamine

Indoor & Outdoor Allergies

­24 Hour Relief of:

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

Walgreens

//druginserts.com/lib/images-otc/cetirizine-13/lbl-25s-300x105.jpg
(click image for full-size original)
CETIRIZINE
cetirizine capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1040
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
POLYETHYLENE GLYCOL 400
SODIUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
GELATIN, UNSPECIFIED
Sorbitol
Mannitol
WATER
1,4-Sorbitan
GLYCERIN
Product Characteristics
Color YELLOW (natural) Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1040-02 1 BOTTLE in 1 CARTON contains a BOTTLE
1 25 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (0363-1040-02)
2 NDC:0363-1040-04 1 BOTTLE in 1 BLISTER PACK contains a BOTTLE
2 40 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the BLISTER PACK (0363-1040-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207235 07/03/2017 05/31/2023
Labeler — Walgreens (008965063)
Registrant — Apotex Inc. (209429182)

Revised: 01/2021 Walgreens

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