Cetirizine Hydrochloride Tablets USP , 5 mg Drug Facts

Active Ingredients

Active Ingredient (in each tablet) PurposeCetirizine HCl USP 5 mg.....................................................................................Antihistimine

Uses

INDICATIONS & USAGE SECTION

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 to an antihistamine containing hydroxyzine.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

OTC - STOP USE SECTION

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.

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

Directions

Adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over	1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
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) [See USP Controlled Room Temperature.]

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-562-4597

SPL UNCLASSIFIED SECTION

Manufactured for:

Drug Ocean, LLC 1 Bridge Plaza, North Central Road,

6th Floor, Suite 675,

Fort Lee, NJ 07024

Manufactured by:

Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals &Pharmaceuticals Ltd.), Mumbai 400 030, India

M.L. G/1430

Rev. 12/2023

Cetirizine Hydrochloride Tablets 5 mg Container Label

DRUG OCEAN NDC 70985-001-01

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP

5 mg

100 Tablets

DRUG OCEAN NDC 70985-001-02