LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)
Available from:
RUGBY LABORATORIES
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat
Authorization status:
Abbreviated New Drug Application
Authorization number:
0536-1144-19, 0536-1144-92, 0536-1144-93

LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet, coated

RUGBY LABORATORIES

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Drug Facts

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP, 5 mg

Purpos e

Antihistamine

Us es

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 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-feding: 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-

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

1/2 tablet (2.5 mg) once daily in the evening may be

appropriate for less severe symptoms

children 6-11 years of

take 1/2 tablet (2.5 mg) once daily in the evening

do not take more than 1/2 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: Bottle: do not use if carton was opened or if printed foil inner seal on bottle is torn or

missing

Blister: Do not use if seal is broken or if individual blister unit is open or torn

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

Call 1-888-375-3784

Carton Label

Rugby

NDC 0536-1144-92

Compare to Xyzal

Allergy 24HR

active ingredient*

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets USP, 5 mg

Antihis tamine

ALLERGY 24 HOUR

Relief of:

Sneezing Runny Nose

Itchy Nose or Throat Itchy, Watery Eyes

35 TABLETS

Bottle Label

Rugby

NDC 0536-1144-92

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets USP

5 mg l Antihistamine

ALLERGY 24 HOUR

35 TABLETS

Blister Carton

LEVOCETIRIZINE DIHYDROCHLORIDE

levocetirizine dihydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -1144(NDC:4359 8 -735)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

levo cetirizine dihydro chlo ride (UNII: SOD6 A38 AGA) (levo cetirizine -

UNII:6 U5EA9 RT2O)

le vo c e tiriz ine

dihydro c hlo ride

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Po lyethylene Glyco l, Unspecified (UNII: 3WJQ0 SDW1A)

RUGBY LABORATORIES

Product Characteristics

Color

white

S core

2 pieces

S hap e

OVAL

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -1144-9 2

1 in 1 CARTON

0 4/20 /20 18

1

35 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 536 -1144-9 3

1 in 1 CARTON

0 4/20 /20 18

2

55 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 536 -1144-19

2 in 1 CARTON

0 7/0 6 /20 18

3

5 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA210 375

0 4/20 /20 18

Labeler -

RUGBY LABORAT ORIES (079246066)

Revised: 7/2018

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