CETIRIZINE HCL- cetirizine tablet, film coated

Cetirizine HCl by

Drug Labeling and Warnings

Cetirizine HCl by is a Otc medication manufactured, distributed, or labeled by GERI-CARE PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetirizine HCl 10 mg

PURPOSE

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing,
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

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 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

• Adults and children 6 years and over: one 10 mg tablet ; once daily; ; do not take more ; than one 10 mg ; tablet in 24 hours. ; A 5 mg product ; may be appropriate ; for less severe ; symptoms.
• Adults 65 years and over: ask a doctor
• Children under 6 years of age: ask a doctor
• Consumers with liver or kidney disease: ask a doctor

Other information

store between 20° to 25°C (68° to 77°F).

INACTIVE INGREDIENT

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone,
pregelatinized starch, and titanium dioxide.

Questions or comments?

1-800-540-3765
Weekdays 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL 
cetirizine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-992
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	C;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-992-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076047	04/24/2025

Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)