CETIRIZINE HYDROCHLORIDE tablet

ACTIVE INGREDIENTS

Active Ingredients (in each tablet) Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine
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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
ASK DOCTOR/PHARMACIST

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

Stop use and ask a doctor if an allergic reaction tothis 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. 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 at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]
INACTIVE INGREDIENTS

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
QUESTIONS?

Call 1-866-562-4597
SPL UNCLASSIFIED SECTION

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:

Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

M. L. G/1430 May 2018

120005
PRINCIPAL DISPLAY PANEL-100'S COUNT

———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-10
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
100 Tablets
PRINCIPAL DISPLAY PANEL-500'S COUNT

———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-50
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
500 Tablets

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

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

Ingredient Name	Strength
Inactive Ingredients
hypromelloses (UNII: 3NXW29V3WO)
lactose (UNII: J2B2A4N98G)
magnesium stearate (UNII: 70097M6I30)
starch, corn (UNII: O8232NY3SJ)
polyethylene glycol (UNII: 3WJQ0SDW1A)
povidone (UNII: FZ989GH94E)
titanium dioxide (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 16571-402-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009
2	NDC: 16571-402-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077829	10/01/2009

Labeler - Rising Pharmaceuticals, Inc. (835513529)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		650434645	MANUFACTURE(16571-402)

Cetirizine Hydrochloride by