LEVOCETIRIZINE DIHYDROCHLORIDE - levocetirizine dihydrochloride tablet 
Micro Labs Limited

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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 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).

DO NOT USE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

KEEP OUT OF REACH OF CHILDREN

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 than1 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


STORAGE


Inactive ingredients

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide

Questions or comments?

call 1-855-839-8195



PRINCIPAL DISPLAY PANEL


MICRO LABS LIMITED
Container

NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
micro container label
Container-Carton



NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
micro carton label

INVATECH PHARMA SOLUTIONS LLC
Container




NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
invatech container label
Container-Carton



NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine

90 Tablets    MICRO LABS
invatech carton label

LEVOCETIRIZINE DIHYDROCHLORIDE  
levocetirizine dihydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42571-312
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorwhite (White to off-white) Score2 pieces
ShapeOVALSize8mm
FlavorImprint Code LI
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42571-312-532500 in 1 POUCH; Type 0: Not a Combination Product02/01/2019
2NDC:42571-312-901 in 1 CARTON02/01/2019
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:42571-312-11100 in 1 CARTON02/01/2019
3NDC:42571-312-3210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:42571-312-181 in 1 CARTON02/01/2019
410 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21155102/01/2019
Labeler - Micro Labs Limited (862174955)
Establishment
NameAddressID/FEIBusiness Operations
InvaTech Pharma Solutions LLC078602180manufacture(42571-312)
Establishment
NameAddressID/FEIBusiness Operations
Micro Labs Limited915793658manufacture(42571-312)

Revised: 11/2019
Document Id: 96ce7d6a-5c89-b6fa-e053-2a95a90a918c
Set id: 78ff8e86-ee5b-4626-aa81-49e974febf1d
Version: 5
Effective Time: 20191107
 
Micro Labs Limited