ALL DAY ALLERGY ANTIHISTAMINE- cetirizine hydrochloride capsule
Premier Value (Chain Drug Consortium, LLC)

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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 reation 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 1-877-753-3935

Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in ZYRTEC®

ALL DAY ALLERGY

CETIRIZINE HCl CAPSULES 10 mg

ANTIHISTAMINE/INDOOR & OUTDOOR ALLERGIES

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.

Package Label

cetirizine hydrochloride capsules 10 mg

ALL DAY ALLERGY ANTIHISTAMINE
cetirizine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-279
Route of Administration	ORAL	DEA Schedule

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

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

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	CET
Contains

Packaging
#	Item Code	Package Description
1	NDC:68016-279-00	1 in 1 BOX
1		25 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022429	06/01/2013

Labeler - Premier Value (Chain Drug Consortium, LLC) (101668460)

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

Revised: 04/2013

Document Id: 0d6b3439-4b38-4e73-b8fb-b5e520d612a8

Set id: 11c85dbf-f966-4193-9851-45e51a1bb932

Version: 1

Effective Time: 20130403

Premier Value (Chain Drug Consortium, LLC)