LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Drug Facts 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).

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 ■ 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6 to 11 years of age	■ 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: do not use if carton was opened or if individual blister unit is open or torn
Inactive ingredients

Colloidal silicone dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.
Questions or comments?

(855)-280-1079
Principal Display Panel

NDC: 85786-206-30

DR. SIMI

Allergy Relief

Levocetirizine Dihydrochloride
Tablets, USP 5 mg

Antihistamine

24 HOUR Relief of: Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes

30 Tablets

Compare to XYZAL® 24 HR Active Ingredient*

*This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark XYZAL® Allergy 24HR.

Read directions and warnings before use.

Keep this carton.

It has important information.

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com
Carton labeling

INGREDIENTS AND APPEARANCE

LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride tablet, film coated

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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 85786-206-30	2 in 1 CARTON	04/06/2026
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213513	04/06/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Name	Address	ID/FEI	Business Operations
Establishment
Annora Pharma Private Limited		650980746	manufacture(85786-206) , analysis(85786-206)

Do not use