CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride capsule 
Aurohealth LLC

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Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCI 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


adults and children
6 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 or
kidney 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)


Manufactured for:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
 

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India

M.L.No.: 22/MN/AP/2009/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

ALLERGY    NDC 58602-806-04
Original Prescription Strength

Cetirizine HCl Capsules

10 mg
INDOOR + OUTDOOR 
ALLERGIES                                    
CZ10

Antihistamine                              (Actual Size)

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

12 LIQUID GELS*

* LIQUID-FILLED CAPSULES
AUROHEALTH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)

Original Prescription Strength
 ALLERGY       NDC 58602-806-04

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR               CZ10
ALLERGIES                             (Actual Size)


24 HOUR

RELIEF OF

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

12 LIQUID GELS*
* LIQUID-FILLED CAPSULES
AUROHEALTH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (Carton Label)

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-806
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Clear colourless to pale yellow viscous liquid) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code CZ10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-806-041 in 1 CARTON07/20/2018
112 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-806-531 in 1 CARTON07/20/2018
225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-806-121 in 1 CARTON07/20/2018
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-806-1665 in 1 CARTON07/20/2018
465 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910707/20/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-806) , MANUFACTURE(58602-806)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-806) , MANUFACTURE(58602-806)

Revised: 9/2019
 
Aurohealth LLC