LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet, coated 
RUGBY LABORATORIES

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Drug Facts

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-feding: 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

Carton Label

Rugby

NDC 0536-1144-92


Compare to Xyzal®Allergy 24HR
active ingredient*

Original Prescription Strength
Levocetirizine
Dihydrochloride Tablets USP, 5 mg
Antihistamine

ALLERGY 24 HOUR

Relief of:

35 TABLETS

carton

Bottle Label

Rugby

NDC 0536-1144-92

Original Prescription Strength
Levocetirizine
Dihydrochloride Tablets USP
5 mg l Antihistamine

ALLERGY 24 HOUR

35 TABLETS

bottle

Blister Carton

Blister Carton

LEVOCETIRIZINE DIHYDROCHLORIDE 
levocetirizine dihydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1144(NDC:43598-735)
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:0536-1144-921 in 1 CARTON04/20/2018
135 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0536-1144-931 in 1 CARTON04/20/2018
255 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0536-1144-192 in 1 CARTON07/06/2018
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21037504/20/2018
Labeler - RUGBY LABORATORIES (079246066)

Revised: 7/2018
Document Id: 5a7871a8-acf6-8a96-d5b1-d9446a5518cf
Set id: b7ca3a57-8ae9-b464-a55d-a9e986734e7a
Version: 3
Effective Time: 20180706
 
RUGBY LABORATORIES