CETIRIZINE capsule, liquid filled

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by Apotex Corp., Apotex Inc., Accucaps Industries Limited, Glochem Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, Watry Eyes
• Itchy Throat or Nose

Apotex Corp.

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetirizine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60505-4322
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)
Sodium Hydroxide (UNII: 55X04QC32I)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Mannitol (UNII: 3OWL53L36A)
Water (UNII: 059QF0KO0R)
1,4-Sorbitan (UNII: AV0YTZ4E6J)
Shellac (UNII: 46N107B71O)
Titanium Dioxide (UNII: 15FIX9V2JP)
Isopropyl Alcohol (UNII: ND2M416302)
Butyl Alcohol (UNII: 8PJ61P6TS3)
Propylene Glycol (UNII: 6DC9Q167V3)
Ammonia N-13 (UNII: 9OQO0E343Z)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60505-4322-1	1 in 1 CARTON	07/07/2017
1		12 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 60505-4322-2	1 in 1 CARTON	07/07/2017
2		25 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 60505-4322-4	1 in 1 CARTON	07/07/2017
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 60505-4322-5	1 in 1 CARTON	07/07/2017
4		400 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Apotex Corp. (845263701)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	manufacture(60505-4322) , analysis(60505-4322)

Establishment
Name	Address	ID/FEI	Business Operations
Glochem Industries Limited		725585876	api manufacture(60505-4322)