CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride liquid 
Tris Pharma Inc

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Cetirizine Hydrochloride Oral Solution

Drug Facts

ACTIVE INGREDIENT

Active ingredient in each 5 mL teaspoonful                                

Cetirizine Hydrochloride 5 mg

PURPOSE

Hives Relief

USES

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

■ trouble swallowing

■ dizziness or loss of consciousness

■ swelling of tongue

■ swelling in or around mouth

■ trouble speaking

■ drooling

■ wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

DO NOT USE

Do not use

to prevent hives from any known cause such as:

■ foods

■ insect stings

■ medicines

■ latex or rubber gloves

  • because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

ASK DOCTOR

Ask a doctor before use if you have

■ liver or kidney disease. Your doctor should determine if you need a different dose.

■ hives that are an unusual color, look bruised or blistered

■ hives that do not itch

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING

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

Stop use and ask a doctor if

■ an allergic reaction to this product occurs. Seek medical help right away.

■ symptoms do not improve after 3 days of treatment

■ the hives have lasted more than 6 weeks

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding:

■ If breast-feeding: not recommended

■ if pregnant: ask a health professional before use.

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).

DIRECTIONS

Directions

■ use only with enclosed dosing cup

 adults and children 6 years and over  1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severityof symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
 adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
 children under 6 years of age ask a doctor
 consumers with liver or kidney disease ask a doctor

Other information

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ do not use if carton is opened or neckband imprinted “sealed for protection” is broken or missing

INACTIVE INGREDIENT

banana flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucrose.

QUESTIONS

Questions?

call 1-732-940-0358

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27808-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (slightly) Score    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27808-001-02118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/21/201212/13/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09057211/21/201212/13/2016
Labeler - Tris Pharma Inc (947472119)

Revised: 12/2016
 
Tris Pharma Inc