cetirizine hydrochloride 10 MG Oral Tablet

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Drug Information

Imprint:	M;C37
Shape:	C48335
Color:	C48325
Ingredients:	Cetirizine
Size:	8.00
Score:	1
Rxtty:	SCD
Author:	Apotheca Inc.
Inactive Ingredients:	CELLULOSE, MICROCRYSTALLINE / MAGNESIUM STEARATE / HYPROMELLOSE / TITANIUM DIOXIDE

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 Â 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 20Â° to 25Â°C (68Â° to 77Â°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 â€“ 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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDEÂ
cetirizine hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10Â mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	Â
MAGNESIUM STEARATE (UNII: 70097M6I30)	Â
HYPROMELLOSE (UNII: 3NXW29V3WO)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â

#	Item Code	Package Description
Packaging
1	NDC:12634-987-96	6 in 1 BOTTLE, PLASTIC
2	NDC:12634-987-97	7 in 1 BOTTLE, PLASTIC
3	NDC:12634-987-00	10 in 1 BOTTLE, PLASTIC
4	NDC:12634-987-80	20 in 1 BOTTLE, PLASTIC
5	NDC:12634-987-71	30 in 1 BOTTLE, PLASTIC
6	NDC:12634-987-50	50 in 1 BOTTLE, PLASTIC
7	NDC:12634-987-01	100 in 1 BOTTLE, PLASTIC

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

Labeler -Â Apotheca Inc. (051457844)

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