LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet, film coated 
Safrel Pharmaceuticals LLC

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Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

ACTIVE INGREDIENT(S)

Levocetirizine dihydrochloride USP 5 mg


PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat


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

WHEN USING THIS PRODUCT

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

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 to 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 to 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
 

  


OTHER INFORMATION

• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
• safety sealed: do not use if carton was opened or if individual blister unit is open or torn



INACTIVE INGREDIENTS


colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

QUESTIONS or COMMENTS?

call 1-844-384-3723.


Distributed by:
Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

www.safrel.com

PRINCIPAL DISPLAY PANEL

Levocetirizine Dihydrochloride Tablets USP 5 mg-180 Tablets



Compare to XYZAL ® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

Original Prescription Strength

180 TABLETS

levo

LEVOCETIRIZINE DIHYDROCHLORIDE 
levocetirizine dihydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-112
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
Colorwhite (White to off white) Score2 pieces
ShapeOVALSize8mm
FlavorImprint Code H;LL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-112-18180 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21351310/28/2022
Labeler - Safrel Pharmaceuticals LLC (080566287)

Revised: 2/2023
Document Id: f4ab9fca-5fb1-518a-e053-2a95a90a3420
Set id: f4aba1d6-2516-3b8a-e053-2995a90a5626
Version: 1
Effective Time: 20230214
 
Safrel Pharmaceuticals LLC