CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated 
Strategic Sourcing Services LLC

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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:

.

Warnings

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 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

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 right away.

Directions

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

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

Questions?

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL

30 ct Carton

30 ct Carton

Principal Display Panel

30 ct Container label

30 ct Container

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablets tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0414
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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (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:62011-0414-11 in 1 CARTON11/12/201902/28/2025
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62011-0414-21 in 1 CARTON11/12/201902/28/2025
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:62011-0414-31 in 1 CARTON11/12/201902/28/2025
390 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834311/12/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 10/2024
Document Id: 9039ca1d-8d2f-e26e-4386-911fcb9c207b
Set id: 00b01fa8-2533-ff93-bd13-ca472c46bb94
Version: 5
Effective Time: 20241023
 
Strategic Sourcing Services LLC