LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet, coated 
Global Distributors, Inc

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Levocetirzine Dihydrochloride Tablets USP, 5 mg

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

  • ever had trouble urinating or emptying your bladder

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 doctor if

  • you have trouble urinating or emptying your bladder
  • 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 65 years of age and older
  • ask a doctor
adults and children 12-64 years of age
  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age
  • do not use
consumers with kidney disease
  • do not use

Other information

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

Call 1-888-375-3784

Levocetirizine Dihydrochloride Tablets, USP 5 mg carton

1

LEVOCETIRIZINE DIHYDROCHLORIDE 
levocetirizine dihydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81086-996
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize9mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81086-996-121 in 1 CARTON12/01/2020
1120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21037512/01/2020
Labeler - Global Distributors, Inc (791184070)
Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 12/2021
Document Id: d3c1633c-03da-8118-e053-2a95a90a5508
Set id: d3c16343-ab81-168f-e053-2a95a90a2464
Version: 1
Effective Time: 20211222
 
Global Distributors, Inc