CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

Cetirizine Hydrochloride (Allergy) by

Drug Labeling and Warnings

Cetirizine Hydrochloride (Allergy) by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

• 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]

Directions

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

Other information

• store between 20° to 25°C (68° to 77°F)
• TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

AUROHEALTH
Original Prescription Strength             NDC: 58602-444-09
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
  

30
Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)

AUROHEALTH
NDC: 58602-444-21
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 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

AUROHEALTH
NDC: 58602-445-09
*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
24 Hour Relief of :

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

30 Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

AUROHEALTH
NDC: 58602-445-21
*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
24 Hour Relief of :

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

100 (10x10) Tablets
10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-444
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	X;35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-444-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-444-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-444-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-444-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
5	NDC: 58602-444-21	10 in 1 CARTON	08/05/2015
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-445
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-445-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-445-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-445-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-445-15	1 in 1 CARTON	08/05/2015
4		60 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-445-19	1 in 1 CARTON	08/05/2015
5		90 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-445-94	1 in 1 CARTON	08/05/2015
6		100 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 58602-445-38	1 in 1 CARTON	08/05/2015
7		300 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 58602-445-40	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
9	NDC: 58602-445-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
10	NDC: 58602-445-21	10 in 1 CARTON	08/05/2015
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC: 58602-445-01	1 in 1 CARTON	08/05/2015
11		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC: 58602-445-60	1 in 1 CARTON	08/05/2015
12		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC: 58602-445-54	1 in 1 CARTON	08/05/2015
13		70 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 58602-445-65	2 in 1 CARTON	11/21/2019
14		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-812
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	2 pieces
Shape	RECTANGLE (off-rectangular)	Size	9mm
Flavor		Imprint Code	X;2;0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-812-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-812-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-812-99	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC: 58602-812-23	1 in 1 CARTON	08/05/2015
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-812-39	1 in 1 CARTON	08/05/2015
5		365 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 58602-812-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
7	NDC: 58602-812-04	10 in 1 CARTON	08/05/2015
7	NDC: 58602-812-83	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090760	08/05/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-444, 58602-445, 58602-812) , MANUFACTURE(58602-444, 58602-445, 58602-812)