ALLERGY RELIEF- cetirizine hcl tablet 
Pioneer Life Sciences, LLC

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Allergy relief

Active Ingredient (in each caplet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses:

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 sedatives or tranquilizers.

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.

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 a Poison Control Center (1-800 222-1222) right away.

Directions

Adults and children 6 years and older: 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 severe 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 lnfonnation

Inactive Ingredients

Lactose, Povidone, Maize Starch, Magnesium Stearate, Opadry White, Titanium Dioxide, Hypromellose, Polyethylene Glycol

Questions or Comments?

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST.

Package Label

PL0151 Rev 00 Cetirizine HCL 10mg 200ct-Unique-09.08.23

ALLERGY RELIEF 
cetirizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-028
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeBULLET (Barrel shape) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-028-20200 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/26/2023
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 10/2023
Document Id: 4642090f-9b1b-47ce-8b72-bfa842dac580
Set id: 205b42e0-9d02-4755-9ee6-5883147abeb3
Version: 1
Effective Time: 20231027
 
Pioneer Life Sciences, LLC