CETIRIZINE- cetirizine capsule, liquid filled
Walgreens

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Drug Facts

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

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

CETIRIZINE
cetirizine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-1040
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Mannitol (UNII: 3OWL53L36A)
WATER (UNII: 059QF0KO0R)
1,4-Sorbitan (UNII: AV0YTZ4E6J)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	YELLOW (natural)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	10
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-1040-02	1 in 1 CARTON	07/03/2017	01/31/2023
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0363-1040-04	1 in 1 BLISTER PACK	07/03/2017	05/31/2023
2		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207235	07/03/2017	05/31/2023

Labeler - Walgreens (008965063)

Registrant - Apotex Inc. (209429182)

Revised: 1/2021

Document Id: 17d5aaef-5e83-cdfa-8ce3-4c7d4496ba22

Set id: 9c56185f-5179-dd63-3c90-b96358228f9c

Version: 7

Effective Time: 20210126

Walgreens