CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride capsule

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, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 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 DOCTOR

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

ASK DOCTOR/PHARMACIST

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

• adults and children6 years and over: one 10 mg capsule once daily;; do not take more than one 10 mg; capsule 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 orkidney disease: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• avoid high humidity and excessive heat above 40°C (104°F)
• protect from light
• do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Inactive ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

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

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
 

Made in India 
Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label)

PrimaryHealth            NDC: 58602-863-12
ALLERGY
Original
Prescription Strength

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR + OUTDOOR ALLERGIES

40 LIQUID GELS*
* LIQUID-FILLED CAPSULES

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label)

NDC: 58602-863-12
PrimaryHealth
COMPARE TO Zyrtec®
active ingredient*
Original Prescription Strength
 ALLERGY      

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR  ALLERGIES

24 HOUR
RELIEF OF

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

CZ10
(Actual size)

40 LIQUID GELS*
* LIQUID-FILLED CAPSULES

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-863
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW (Clear colourless to pale yellow viscous liquid)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	CZ10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-863-12	1 in 1 CARTON	03/12/2021
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209107	03/12/2021

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-863) , MANUFACTURE(58602-863)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-863) , MANUFACTURE(58602-863)