Active Ingredient (in each tablet)

Cetirizine HCl USP 5 mg

Purpose

Antihistimine

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. (1-800-222-1222)

Directions

Adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
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 1-844-874-7464

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

M.L. G/1430 Jul. 2020

129575

PRINCIPAL DISPLAY PANEL-100'S COUNT

Rising NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 5 mg

Antihistamine
ALLERGY
Indoor & Outdoor Allergies
24 Hour Relief of:
•Sneezing
•Runny Nose
•Itchy, Watery Eyes
•Itchy Throat or Nose

100 Tablets

T10 - M.L. G/1430

cetrizine-5mg-1

cetrizine-5mg-2

cetrizine-5mg-3

T20 - M.L. G/25/2188

cetrizine-5mg-4

cetrizine-5mg-5

cetrizine-5mg-6

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-401
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	5 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)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	7mm
Flavor		Imprint Code	CTN;5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16571-401-10	100 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 Pharma Holdings, Inc. (116880195)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		650434645	ANALYSIS(16571-401) , MANUFACTURE(16571-401)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		864354608	analysis(16571-401) , manufacture(16571-401)

Cetirizine Hydrochloride Tablets USP 5 mg, Allergy