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NDC 42571-0312-90 Levocetirizine Dihydrochloride 5 mg/1 Details

Levocetirizine Dihydrochloride 5 mg/1

Levocetirizine Dihydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Micro Labs Limited. The primary component is LEVOCETIRIZINE DIHYDROCHLORIDE.

MedlinePlus Drug Summary

Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 42571-0312-90
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levocetirizine

Product Information

NDC	42571-0312
Product ID	42571-312_96ce7d6a-5c89-b6fa-e053-2a95a90a918c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Levocetirizine Dihydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Levocetirizine Dihydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LEVOCETIRIZINE DIHYDROCHLORIDE
Labeler Name	Micro Labs Limited
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211551
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42571-0312-90 (42571031290)

Pricing Information	N/A
NDC Package Code	42571-312-90
Billing NDC	42571031290
Package	1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE
Marketing Start Date	2019-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 78ff8e86-ee5b-4626-aa81-49e974febf1d Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211551	02/01/2019

Labeler - Micro Labs Limited (862174955)

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

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

Revised: 11/2019

Document Id: 96ce7d6a-5c89-b6fa-e053-2a95a90a918c

Set id: 78ff8e86-ee5b-4626-aa81-49e974febf1d

Version: 5

Effective Time: 20191107

Search by Drug Name or NDC

NDC 42571-0312-90 Levocetirizine Dihydrochloride 5 mg/1 Details

Levocetirizine Dihydrochloride 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 42571-0312-90 (42571031290)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 78ff8e86-ee5b-4626-aa81-49e974febf1d Details

Active ingredient (in each tablet)

Purpose

Uses

WARNINGS

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding:

Keep out of reach of children.

DO NOT USE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

STORAGE

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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