Cetirizine hydrochloride liquid
Spl unclassified section
Active ingredient in each 5 mL teaspoonful
Cetirizine Hydrochloride 5 mg
relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptoms:
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
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 preventhives from any known cause such as:
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 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 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.
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).
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|
store between 20 to 25C (68 to 77F)
do not use if carton is opened or neckband imprinted sealed for protection is broken or missing
banana flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucrose.
Ingredients and appearance - Product information
Cetirizine hydrochloride liquid- Cetirizine hydrochloride
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 27808-001|
|Route of Administration||Oral|
|Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 )||5 mgin 5 mL|
|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)|
|#||Item Code||Package Description||Marketing Start Date|
|1||NDC: 27808-001-02||118mL in 1 BOTTLE, GLASS||2012/11/21|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|