CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated 
Proficient Rx LP

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Cetirizine Hydrochloride Tablets

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

Purpose

Antihistamine

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

Ask a doctor before use if you have

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining 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

Ask a doctor or pharmacist before use if you are taking 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

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

Keep out of reach of children. In case of overdose, get medical help or contact a 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 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 information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions?

call 1-888-375-3784

Bottle Label

71205-709-06
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablets tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-709(NDC:43598-811)
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize7mm
FlavorImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-709-066 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
2NDC:71205-709-1010 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
3NDC:71205-709-1414 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
4NDC:71205-709-2020 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
5NDC:71205-709-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
6NDC:71205-709-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
7NDC:71205-709-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834312/17/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-709) , RELABEL(71205-709)

Revised: 10/2022
Document Id: 55b1738c-fa72-4cd1-a8e8-be41b12b593d
Set id: 55b1738c-fa72-4cd1-a8e8-be41b12b593d
Version: 1
Effective Time: 20221001
 
Proficient Rx LP