ALL DAY ALLERGY- cetirizine hydrochloride capsule 
Cardinal Health (Leader) 37205

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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:

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.

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

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

Call 1-800-200-6313 Monday through Friday 9AM - 5PM EST.

Principal Display Panel

Compare to Zyrtec® active ingredient†

All Day Allergy

Cetirizine HCl Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 HOUR RELIEF OF:

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OH  43017

www.myleader.com

Package Labeling

Cetirizine HCl 10 mg

Leader All Day Allergy Softgel

ALL DAY ALLERGY 
cetirizine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-819
Route of Administration ORAL DEA Schedule     
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
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 13mm
Flavor Imprint Code CET
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-819-63 1 in 1 PACKAGE
1 25 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 03/03/2013
Labeler - Cardinal Health (Leader) 37205 (097537435)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 3/2013
Document Id: 7c761d3b-3499-44f9-902e-5768606f547f
Set id: a7df5046-5cd6-44d6-aa3c-58810115fe7d
Version: 2
Effective Time: 20130311
 
Cardinal Health (Leader) 37205