992

992
SPL v1
SPL
SPL Set ID 3389e947-b7d1-6caf-e063-6294a90a2238
Route
ORAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Starch, Corn Lactose Monohydrate Magnesium Stearate Polysorbate 80 Povidone, Unspecified Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: C;2 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-24

Description

Cetirizine HCl 10 mg


Medication Information

Dosage and 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

Description

Cetirizine HCl 10 mg

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

Section 50565-1

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.

Section 51727-6

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone,

pregelatinized starch, and titanium dioxide.

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Cetirizine HCl 10 mg

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.
Other Information

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

Questions Or Comments?

1-800-540-3765

Weekdays 9AM-5PM EST


Structured Label Content

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

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone,

pregelatinized starch, and titanium dioxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Cetirizine HCl 10 mg

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.
Other Information (Other information)

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Weekdays 9AM-5PM EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)