CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Marlex Pharmaceuticals, Inc

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Cetirizine Hydrochloride

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

Do not useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you aretaking 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 ifan 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 (1-800-222-1222).

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

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

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 10/22 SP

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 10135-0762-30

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

30 TABLETS

label1

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

762-90NDC 10135-0762-90

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

90 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 10135-0762-01

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

100 TABLETS

762-01

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 10135-0762-03

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

300 TABLETS

label3

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 10135-0762-05

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE

500 TABLETS

0762-05

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-762
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (rounded-off) Size9mm
FlavorImprint Code RI52
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-762-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
2NDC:10135-762-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
3NDC:10135-762-03300 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
4NDC:10135-762-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
5NDC:10135-762-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749810/01/2022
Labeler - Marlex Pharmaceuticals, Inc (782540215)

Revised: 10/2023
Document Id: 08a1a524-4759-c7f7-e063-6294a90aa57f
Set id: eb917099-fecf-6b55-e053-2995a90aaafa
Version: 3
Effective Time: 20231026
 
Marlex Pharmaceuticals, Inc