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

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

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 breastfeeding,

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 at room temperature 20°– 25°C (68°– 77°F)
do not use if imprinted seal under safety cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Allergy Relief

ALLERY RELIEF 24HR
allery relief 24hr tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-451
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	8mm
Flavor		Imprint Code	H;LL
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-451-06	120 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2024
2	NDC:69168-451-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213513	04/02/2024

Labeler - Allegiant Health (079501930)

451 - Allergy Relief 24HR