ACTIVE INGREDIENT

(in each Tablet)
Cetirizine HCI 10mg

PURPOSE

ANTIHISTAMINE
24 Hour Relief of Indoor and Outdoor Allergies

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

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

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 Poison Control Center right away.

Directions

Adults and children 6 years and over	one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours.
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 and inactive ingredients

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

NDC 12634-987-71
CETIRIZINE HCI
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of Sneezing, Runny Nose, Itchy,
Watery Eyes, Itchy Throat or Nose.
Allergy Tablets
RejuviLife
30 Tablets
10 MG

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	12634-987 (0378-3637)
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
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
HYPROMELLOSE
TITANIUM DIOXIDE

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	M;C37
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	12634-987-96	6 TABLET In 1 BOTTLE, PLASTIC	None
2	12634-987-97	7 TABLET In 1 BOTTLE, PLASTIC	None
3	12634-987-00	10 TABLET In 1 BOTTLE, PLASTIC	None
4	12634-987-80	20 TABLET In 1 BOTTLE, PLASTIC	None
5	12634-987-71	30 TABLET In 1 BOTTLE, PLASTIC	None
6	12634-987-50	50 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076677	01/01/2010

Labeler - Apotheca Inc. (051457844)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Inc.		051457844	repack, relabel

Revised: 02/2010Apotheca Inc.