Cetirizine by Contract Pharmacy Services-PA / Coupler Enterprises Inc. CETIRIZINE tablet

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA, Coupler Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• HIGHLIGHTS OF PRESCRIBING INFORMATION

  Cetirizine 10mg 680
  "These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

  DOSAGE AND ADMINISTRATION

  adults and children 6 years and over (4)

  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. (4)

  adults 65 years and over (4)

  ask a doctor (4)

  children under 6 years of age (4)

  ask a doctor (4)

  consumers with liver or kidney disease (4)

  ask a doctor (4)

  INDICATIONS AND USAGE

  temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: (6)

  
  runny nose
  
  sneezing
  
  itchy, watery eyes
  
  itching of the nose or throat (6)

  Revised: 2/2018

• Table of Contents

  FULL PRESCRIBING INFORMATION: CONTENTS*

  * Sections or subsections omitted from the full prescribing information are not listed.

ACTIVE INGREDIENT

Cetirizine HCL 10MG

PURPOSE

Antihistamine

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)

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-680(NDC:45802-919)
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
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67046-680-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	02/14/2018

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises Inc.		945429777	repack(67046-680)