CETIRIZINE- cetirizine capsule, liquid filled 
TARGET CORPORATION

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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 overone 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 olderask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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

original prescription strength

allergy Relief

Cetirizine HCl Capsules 10 mg

Antihistamine

Indoor & Outdoor Allergies

­24 Hour   Relief of:

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

Target

LBL-25s.jpg

Principal Display Panel

­original prescription strength

allergy Relief

Cetirizine HCl Capsules 10 mg

Antihistamine

Indoor & Outdoor Allergies

­24 Hour Relief of:SneezingRunny NoseItchy, Watery EyesItchy Throat or Nose

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

CTN-25s

CETIRIZINE 
cetirizine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-219
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (natural) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code 10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-219-0225 in 1 BOTTLE; Type 0: Not a Combination Product12/06/201711/30/2021
2NDC:11673-219-0440 in 1 BOTTLE; Type 0: Not a Combination Product12/06/201711/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20723512/06/201711/30/2021
Labeler - TARGET CORPORATION (006961700)
Registrant - Apotex Inc. (209429182)

Revised: 3/2020
Document Id: f1202eba-8b5d-c22f-e8a2-cd81a7a85755
Set id: 8ad32784-7fef-cb5d-953f-e7e740b51c10
Version: 4
Effective Time: 20200306
 
TARGET CORPORATION