Cetirizine Hydrochloride Tablets, 5 mg, Allergy

Active Ingredients

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.

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 tablet1 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 between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions?

Call 1-866-562-4597

Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

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

DRUG: Cetirizine Hydrochloride

GENERIC: Cetirizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-011-02

COLOR: white

SHAPE: BULLET

SCORE: No score

SIZE: 7 mm

IMPRINT: CTN;5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

Cetirizine Hydrochloride 5mg in 1

INACTIVE INGREDIENT(S):

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

Remedy_Label

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-011(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:61786-011-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/02/2014	08/18/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077829	09/02/2014	08/18/2016

Labeler - REMEDYREPACK INC. (829572556)

Revised: 8/2017

Document Id: 57750474-6e3a-e654-e053-2991aa0af7d9

Set id: cfaea950-4e2b-49fe-814a-ca606e05be2c

Version: 3

Effective Time: 20170823

REMEDYREPACK INC.