Label: CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet
- NDC Code(s): 63629-4914-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 16571-401
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 25, 2013
If you are a consumer or patient please visit this version.
- Active Ingredients
Active Ingredients (in each tablet) PurposeCetirizine HCl 5 mg.....................................................................................Antihistimine
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.Close
- ASK DOCTOR
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.Close
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.Close
- When using this product
- drowsines may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinary.
- STOP USE
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.Close
- 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 Poison Control Center right away.Close
Adults and children 6
years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet 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)Close
- Inactive Ingredients
hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.Close
- SPL UNCLASSIFIED SECTION
Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.
Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.Close
- PRINCIPAL DISPLAY PANEL
Cetirizine 5mg TabletClose
- INGREDIENTS AND APPEARANCE
cetirizine hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4914(NDC:16571-401) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (White) Score no score Shape BULLET (Barrel Shaped) Size 7mm Flavor Imprint Code CTN;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-4914-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-4914) , RELABEL(63629-4914)