CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet
REMEDYREPACK INC.

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Cetirizine Hydrochloride Tablets, 10 mg, Allergy

OTC - ACTIVE INGREDIENT

Active Ingredients (in each tablet) Purpose

Cetirizine HCl 10 mg..............................................................................................Antihistimine

OTC - PURPOSE

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.

OTC - ASK DOCTOR

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

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

OTC - WHEN USING

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

OTC - STOP USE

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 sever 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

INDICATIONS & USAGE

SPL UNCLASSIFIED

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

INACTIVE INGREDIENT

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

OTC - QUESTIONS

Call 1-866-562-4597

SPL UNCLASSIFIED

Manufactured for PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-332-08

ACTIVE INGREDIENT(S):

Cetirizine Hydrochloride 10mg in 1

INACTIVE INGREDIENT(S):

hypromelloses
polyethylene glycol
povidone
starch, corn
lactose
magnesium stearate
titanium dioxide

COLOR: white

SHAPE: BULLET

SCORE: No score

SIZE: 8 mm

IMPRINT: CTN;10

PACKAGING: 10 in 1 BOTTLE

MM1

MM2

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52125-332(NDC:16571-402)
Route of Administration	ORAL

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)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	BULLET (TABLET)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52125-332-08	10 in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2014	01/16/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077829	08/27/2014	01/16/2017

Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2017

Document Id: 46420038-b265-1c8a-e054-00144ff88e88

Set id: 51534bb6-dfab-4b76-9c70-d0782079a250

Version: 2

Effective Time: 20170116

REMEDYREPACK INC.