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NDC 69230-0321-32 Levocetirizine Dihydrochloride 5 mg/1 Details

Levocetirizine Dihydrochloride 5 mg/1

Levocetirizine Dihydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care Inc. 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: 69230-0321-32
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levocetirizine

Product Information

NDC	69230-0321
Product ID	69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e
Associated GPIs	41550027100320
GCN Sequence Number	048920
GCN Sequence Number Description	levocetirizine dihydrochloride TABLET 5 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	14901
HICL Sequence Number	022959
HICL Sequence Number Description	LEVOCETIRIZINE DIHYDROCHLORIDE
Brand/Generic	Generic
Proprietary Name	Levocetirizine Dihydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Levocetirizine Dihydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LEVOCETIRIZINE DIHYDROCHLORIDE
Labeler Name	Camber Consumer Care Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213513
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0321-32 (69230032132)

Pricing Information	N/A
NDC Package Code	69230-321-32
Billing NDC	69230032132
Package	1 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2020-10-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be72dafb-62ae-40b2-874f-1d8920fad19d Details

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

SPL UNCLASSIFIED SECTION

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 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 1-888-588-1418.

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

PRINCIPAL DISPLAY PANEL

Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton

Compare to XYZAL® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label

Compare to XYZAL® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

•Sneezing

•Runny Nose

•Itchy Nose or Throat

•Itchy, Watery Eyes

Original Prescription Strength

35 TABLETS

INGREDIENTS AND APPEARANCE

LEVOCETIRIZINE DIHYDROCHLORIDE

levocetirizine dihydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-321
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	WHITE (White to off white)	Score	2 pieces
Shape	OVAL	Size	8mm
Flavor		Imprint Code	H;LL
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-321-31	1 in 1 CARTON	10/28/2020
1		35 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69230-321-32	1 in 1 CARTON	10/28/2020
2		55 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:69230-321-33	1 in 1 CARTON	10/28/2020
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69230-321-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2020
5	NDC:69230-321-01	10 in 1 CARTON	10/28/2020
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:69230-321-34	1 in 1 CARTON	10/28/2020
6		180 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	ANDA213513	10/28/2020

Labeler - Camber Consumer Care Inc (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Hetero Labs Limited Unit III		676162024	ANALYSIS(69230-321) , MANUFACTURE(69230-321)

Revised: 11/2020

Document Id: 7ca0cee0-b628-4266-b361-ad5c52b6f11e

Set id: be72dafb-62ae-40b2-874f-1d8920fad19d

Version: 4

Effective Time: 20201130

Search by Drug Name or NDC

NDC 69230-0321-32 Levocetirizine Dihydrochloride 5 mg/1 Details

Levocetirizine Dihydrochloride 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 69230-0321-32 (69230032132)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL be72dafb-62ae-40b2-874f-1d8920fad19d Details

ACTIVE INGREDIENT(S)

PURPOSE

USE(S)

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS or COMMENTS?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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