CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by RedPharm Drug. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking 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 ifan 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.
• store between 20° to 25° C (68° to 77° 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

Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC: 51660-939-53

†Compare To
the active ingredient of
Zyrtec ®

ohm ®
Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE
Indoor & Outdoor Allergies

24 Hour Relief of:
Sneezing Runny Nose
Itchy, Watery Eyes Itchy Throat or Nose

300 TABLETS
10 mg EACH

24
Hours

Original Prescription Strength

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67296-1024(NDC:51660-939)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67296-1024-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007

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

Labeler - RedPharm Drug (828374897)

Registrant - RedPharm Drug (828374897)

Establishment
Name	Address	ID/FEI	Business Operations
RedPharm Drug		828374897	repack(67296-1024)