Cetirizine hydrochloride (allergy) capsule

Spl unclassified section

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 useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Otc - ask doctor section

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

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking 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 20-25C (68-77F)
  • avoid high humidity and excessive heat above 40C (104F)
  • 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

Ingredients and appearance - Product information

Cetirizine hydrochloride (allergy) capsule- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-806
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
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) Shape OVAL
Size 13 mm Score 1
Imprint Code CZ10

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209107 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-806), MANUFACTURE( 58602-806)

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)

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