MEDLINE- cetirizine hcl tablet 
Medline Industries, LP

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033 Cetirizine HCl tablets

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 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 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 (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

store between 20º -25ºC (68º -77ºF)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white OY-58900, purified water

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

Manufacturing Information

Manufactrued for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00015

V1 RE22HND

Package Label

Label V1 RE22HND

MEDLINE 
cetirizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-033
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorwhite ((to off white)) Scoreno score
ShapeRECTANGLE ((rounded off rectangular shaped)) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-033-3330 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:53329-033-3890 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927405/01/2020
Labeler - Medline Industries, LP (025460908)

Revised: 9/2022
Document Id: e9ab1c23-5f93-d015-e053-2a95a90a6400
Set id: a75cd557-e19b-fdd4-e053-2a95a90a8097
Version: 5
Effective Time: 20220927
 
Medline Industries, LP