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Cetirizine Capsules

Generic Name: cetirizine hydrochloride
Dosage Form: capsule, liquid filled

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 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 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:10888-7127
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
MANNITOL  
POLYETHYLENE GLYCOL 400  
WATER  
SODIUM HYDROXIDE  
SORBITAN  
SORBITOL  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10888-7127-1 1 BAG (1 BAG) in 1 BOX
1 15000 CAPSULE, LIQUID FILLED (15000 CAPSULE) in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 02/08/2010
Labeler - Banner Pharmacaps Inc. (002193829)
Revised: 11/2010
 
Banner Pharmacaps Inc.



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