CETIRIZINE HYDROCHLORIDE tablet, orally disintegrating

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

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

Tablet melts in mouth. Can be taken with or without water.

• 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). Avoid high humidity.
• do not use if carton or blister unit is opened or broken 
• see side panel for lot number and expiration date

Inactive ingredients

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

Questions or comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

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

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

AUROHEALTH
NDC: 58602-838-75
*Compare to the active
ingredient of Zyrtec® Allergy
Original Prescription Strength
Cetirizine Hydrochloride
Orally Disintegrating Tablets, USP 10 mg
Antihistamine
Allergy
Dissolve Tabs
Indoor + Outdoor Allergies 
24 Hour Relief of:

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

Melts In Your Mouth
ORANGE FLAVOR
Actual Size

12 Orally
Disintegrating
Tablets
10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-838
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
BETADEX (UNII: JV039JZZ3A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor	ORANGE	Imprint Code	CE;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-838-75	2 in 1 CARTON	09/11/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 58602-838-76	4 in 1 CARTON	09/11/2020
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 58602-838-14	11 in 1 CARTON	09/11/2020
3		6 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	ANDA213557	09/11/2020

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-838) , MANUFACTURE(58602-838)