CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
Unichem Pharmaceuticals (USA), Inc.

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Cetirizine Hydrochloride Tablets USP

DRUG FACTS

ACTIVE INGREDIENT

(IN EACH TABLET)

For 5 mg

Cetirizine Hydrochloride USP, 5 mg

For 10 mg

Cetirizine Hydrochloride USP, 10 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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.(1-800-222-1222)

DOSAGE AND ADMINISTRATION

For 5 mg

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

For 10 mg

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

STORAGE AND HANDLING

store between 20oto 25oC (68o to 77oF)

INACTIVE INGREDIENT

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

QUESTIONS

call 1-866-562-4616 from Monday to Friday between 8.00 Am to 8.00 PM, EST

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India.

Manufactured for:

Hasbrouck Heights, NJ 07604.

PRINCIPAL DISPLAY PANEL

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29300-133
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
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	RECTANGLE (Rounded-off)	Size	7mm
Flavor		Imprint Code	U;133
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:29300-133-13	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
2	NDC:29300-133-45	45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
3	NDC:29300-133-75	75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
4	NDC:29300-133-19	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
5	NDC:29300-133-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
6	NDC:29300-133-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
7	NDC:29300-133-99	66500 in 1 DRUM; Type 0: Not a Combination Product	06/01/2018	01/20/2020
8	NDC:29300-133-00	200000 in 1 DRUM; Type 0: Not a Combination Product	06/01/2018	01/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078680	06/26/2009	01/20/2020

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29300-134
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
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	RECTANGLE (Rounded Off)	Size	9mm
Flavor		Imprint Code	U;134
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:29300-134-13	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
2	NDC:29300-134-45	45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
3	NDC:29300-134-75	75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
4	NDC:29300-134-19	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
5	NDC:29300-134-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
6	NDC:29300-134-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
7	NDC:29300-134-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
8	NDC:29300-134-50	5000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2018	01/20/2020
9	NDC:29300-134-99	35700 in 1 DRUM; Type 0: Not a Combination Product	06/01/2018	01/20/2020
10	NDC:29300-134-00	100000 in 1 DRUM; Type 0: Not a Combination Product	06/01/2018	01/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078680	06/26/2009	01/20/2020

Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 1/2020

Document Id: 0a54888d-c949-44f5-b559-cc8d35bc7da3

Set id: 3a7b2304-daef-4580-b7e7-4fbd8c8d888f

Version: 6

Effective Time: 20200120

Unichem Pharmaceuticals (USA), Inc.