LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet

Levocetirizine Dihydrochloride by

Drug Labeling and Warnings

Levocetirizine Dihydrochloride by is a Otc medication manufactured, distributed, or labeled by Micro Labs Limited, InvaTech Pharma Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

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

• 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 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

• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or torn

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

Container-Carton

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

90 Tablets    MICRO LABS


INVATECH PHARMA SOLUTIONS LLC
Container

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

90 Tablets    MICRO LABS

Container-Carton

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

90 Tablets    MICRO LABS

INGREDIENTS AND APPEARANCE

LEVOCETIRIZINE DIHYDROCHLORIDE  
levocetirizine dihydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42571-312
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)	LEVOCETIRIZINE DIHYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (White to off-white)	Score	2 pieces
Shape	OVAL	Size	8mm
Flavor		Imprint Code	LI
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42571-312-53	2500 in 1 POUCH; Type 0: Not a Combination Product	02/01/2019
2	NDC: 42571-312-90	1 in 1 CARTON	02/01/2019
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 42571-312-11	100 in 1 CARTON	02/01/2019
3	NDC: 42571-312-32	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 42571-312-18	1 in 1 CARTON	02/01/2019
4		10 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211551	02/01/2019

Labeler - Micro Labs Limited (862174955)

Establishment
Name	Address	ID/FEI	Business Operations
InvaTech Pharma Solutions LLC		078602180	manufacture(42571-312)

Establishment
Name	Address	ID/FEI	Business Operations
Micro Labs Limited		915793658	manufacture(42571-312)