XYZAL ALLERGY 24HR- levocetirizine dihydrochloride tablet 
Chattem, Inc.

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Xyzal Allergy 24HR

Xyzal Allergy 24HR Tablet

Drug Facts

Active ingredient

(in each tablet)

Levocetirizine dihydrochloride 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 a 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
■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age■ take ½ tablet (2.5 mg) once daily in the evening
■ do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age■ do not use
consumers with kidney disease■ do not use

(Note: Age ranges are bolded in the draft container labeling for tablet bottle)

Other information

(if bottled) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

(if stretch card) safety sealed: do not use if sealed package was torn or opened, or if printed foil inner seal on bottle is torn or missing

Inactive ingredients

Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

call 1-800-633-1610

PRINCIPAL DISPLAY PANEL

NDC 41167-3510-0
XYZAL
Allergy 24HR
5 mg
10 Tablets

PRINCIPAL DISPLAY PANEL
NDC 41167-3510-0
XYZAL
Allergy 24HR
5 mg
10 Tablets

PRINCIPAL DISPLAY PANEL

NDC 41167-3510-1
XYZAL
Allergy 24HR
5 mg
35 Tablets

PRINCIPAL DISPLAY PANEL
NDC 41167-3510-1
XYZAL
Allergy 24HR
5 mg
35 Tablets

XYZAL ALLERGY 24HR 
levocetirizine dihydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3510
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize8mm
FlavorImprint Code X;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-3510-01 in 1 CARTON03/10/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-3510-11 in 1 CARTON03/10/2017
235 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41167-3510-21 in 1 CARTON03/10/2017
355 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:41167-3510-31 in 1 CARTON03/10/2017
480 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:41167-3510-42 in 1 CARTON03/10/2017
555 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20908903/10/2017
Labeler - Chattem, Inc. (003336013)

Revised: 3/2017
Document Id: 1f760743-b091-4a49-aad2-6246b3ac479c
Set id: 8be45c2a-1eca-4a00-81b9-f7babdbdcd41
Version: 3
Effective Time: 20170310
 
Chattem, Inc.