CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated 
Northwind Pharmaceuticals, 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

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 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

NDC 51655-801-52

51655-801-84

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablets tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51655-801(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
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:51655-801-5230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2023
2NDC:51655-801-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2023
3NDC:51655-801-8414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07834301/25/2023
Labeler - Northwind Pharmaceuticals, LLC (036986393)
Registrant - Northwind Pharmaceuticals, LLC (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals, LLC036986393repack(51655-801)

Revised: 3/2023
Document Id: f70875ab-2430-4876-e053-6294a90a8092
Set id: f70886af-a8a4-63a0-e053-6294a90a2d2c
Version: 1
Effective Time: 20230316
 
Northwind Pharmaceuticals, LLC