cetirizine hydrochloride 10 MG Oral Tablet

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Pill Identifier Information of cetirizine hydrochloride 10 MG Oral Tablet

Drug Information

Imprint:	RI52
Shape:	C48347
Color:	C48325
Ingredients:	Cetirizine
Size:	9.00
Score:	1
Rxtty:	SCD
Author:	Rebel Distributors Corp
Inactive Ingredients:	POVIDONE / LACTOSE MONOHYDRATE / MAGNESIUM STEARATE / STARCH, CORN / TALC / TITANIUM DIOXIDE / POLYETHYLENE GLYCOLS / HYPROMELLOSES

Complete Information

ACTIVE INGREDIENT (IN EACH TABLET)

Cetirizine HCl, USP 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
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 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 (1-800-222-1222).
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. 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
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.(for bottle cartons/stand-alone labels only)
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.(for blister cartons only)
- store between 20Â° to 25Â° C (68Â° to 77Â° F)
INACTIVE INGREDIENTS

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide
QUESTIONS?

call 1-800-406-7984
SPL UNCLASSIFIED SECTION

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDEÂ
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42254-138(NDC:51660-939)
Route of Administration	ORAL

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
POVIDONE (UNII: FZ989GH94E)	Â
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)	Â
MAGNESIUM STEARATE (UNII: 70097M6I30)	Â
STARCH, CORN (UNII: O8232NY3SJ)	Â
TALC (UNII: 7SEV7J4R1U)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)	Â
HYPROMELLOSES (UNII: 3NXW29V3WO)	Â

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE (rounded-off)	Size	9mm
Flavor		Imprint Code	RI52
Contains	Â Â Â Â

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42254-138-14	14 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077498	12/27/2007

Labeler -Â Rebel Distributors Corp (118802834)

Name	Address	ID/FEI	Business Operations
Establishment
Rebel Distributors Corp		118802834	RELABEL, REPACK