CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Cetirizine Hydrochloride Tablets, 5 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                        PurposeCetirizine HCl 5 mg.....................................................................................Antihistimine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

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)

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-562-4597

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.

Cetirizine 5mg Tablet

Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-4914(NDC:16571-401)
Route of Administration ORAL DEA Schedule     
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)

Revised: 4/2013
Document Id: 1f6c4fa3-41dd-4eee-bd89-50c108a5935e
Set id: ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7
Version: 1000
Effective Time: 20130425
 
Bryant Ranch Prepack