ALL DAY ALLERGY RELIEF- cetirizine hydrochloride capsule
QUALITY CHOICE (Chain Drug Marketing Association)

----------

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
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

store between 20°-25°C (68°-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light

Inactive Ingredients

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

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ZYRTEC®

All Day Allergy Relief

Indoor & Outdoor Allergies

Cetirizine HCl Capsules 10 mg | Antihistamine

24 HOUR RELIEF OF: Sneezing | Runny nose

Itchy, Watery Eyes | Itchy Throat or Nose

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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Labeling

Quality Choice All Day Allergy Relief Softgels

ALL DAY ALLERGY RELIEF
cetirizine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:63868-107
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MANNITOL
POLYETHYLENE GLYCOLS
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL (oval)	Size	7mm
Flavor		Imprint Code	CET
Contains

#	Item Code	Package Description
Packaging
1	NDC:63868-107-25	1 in 1 BOX
1		25 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022429	03/03/2013

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013

Document Id: b19d314f-a5ce-4b66-a862-9a9ebfc72009

Set id: 07b1d77c-4c02-4a88-924d-64d35c4ee7b3

Version: 1

Effective Time: 20130214

QUALITY CHOICE (Chain Drug Marketing Association)