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

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.
Active Ingredient

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

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

Other Information

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

Description

Cetirizine HCl 10 mg

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

Questions Or Comments?

1-800-540-3765

Weekdays 9AM-5PM EST


Structured Label Content

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.
Active Ingredient (55106-9)

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

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

Other Information (Other information)

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

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Weekdays 9AM-5PM EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)