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

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
carton

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

bottle label

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)

Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

ACTIVE INGREDIENT(S)

PURPOSE

USE(S)

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