CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride capsule, liquid filled 
Banner Pharmacaps Inc.

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Drug Facts

Active ingredient(in each capsule)

Cetirizine HCl 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 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 PoisonControlCenter right away. (1-800-222-1222)

Directions

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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 foil inner seal printed with "Safety Seal®" is broken or missing

Inactive ingredients


gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Principal Display Panel

NDC 10888-7127-1

Cetirizine Dihydrochloride, 10 mg

(Liquid Filled Capsules)

15, 000 Softgels

10 mg

IMPORTANT

This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance  with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.

CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY

BANNER PHARMACAPS SHIPPING LABEL

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10888-7127
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOL 400 
WATER 
SODIUM HYDROXIDE 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10888-7127-11 in 1 BOX
115000 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02242902/08/2010
Labeler - Banner Pharmacaps Inc. (002193829)

Revised: 11/2010
 
Banner Pharmacaps Inc.