CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Clinical Solutions Wholesale

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Cetirizine Hydrochloride Tablets, 10 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine

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

•
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 and ask a 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 Poison Control Center right away.

Directions

Adults and children 6
 years and over

one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less sever 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 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 PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Cetirizine Hydrochloride Tablets 10 mg Container Label

10mg Packet

Principal Display Panel

Cet10Lab3

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Cet10Lab6

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Cet10Lab9

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CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58118-0402(NDC:16571-402)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
starch, corn (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONES (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58118-0402-830 in 1 BLISTER PACK; Type 0: Not a Combination Product10/01/200906/28/2017
2NDC:58118-0402-01 in 1 PACKET; Type 0: Not a Combination Product10/01/200906/28/2017
3NDC:58118-0402-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/200906/28/2017
4NDC:58118-0402-660 in 1 BOTTLE; Type 0: Not a Combination Product10/01/200906/28/2017
5NDC:58118-0402-990 in 1 BOTTLE; Type 0: Not a Combination Product10/01/200906/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/200906/28/2017
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIBusiness Operations
Clinical Solutions Wholesale078710347REPACK(58118-0402) , RELABEL(58118-0402)

Revised: 6/2017
Document Id: e34b08fd-647d-409c-bf77-3113ea7ca456
Set id: ea70b002-a067-4658-8d53-3e4f9fe30af9
Version: 4
Effective Time: 20170628
 
Clinical Solutions Wholesale