CETIRIZINE HYDROCHLORIDE tablet, film coated

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Northstar Rx LLC, Orchid Pharma Ltd., Orchid Healthcare (A Division of Orchid Pharma Ltd.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Cetirizine Hydrochloride 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.

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

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

Inactive ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

call toll free 1-800-206-7821

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 16714-271-02

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

Allergy

6 Years and Older

24 Hour Relief of:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

NORTHSTARTM

100 Tablets 10 mg Each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16714-271
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
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	capsule (rounded off rectangular)	Size	9mm
Flavor		Imprint Code	S;521
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16714-271-02	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2009
2	NDC: 16714-271-03	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078862	10/19/2009

Labeler - Northstar Rx LLC (830546433)

Registrant - Orchid Pharma Ltd. (650133507)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Healthcare (A Division of Orchid Pharma Ltd.)		650288850	manufacture(16714-271) , analysis(16714-271) , pack(16714-271) , label(16714-271)