682r Timely 49483-682 Cetirizine Hydrochloride Tablets Usp 5 Mg

682r Timely 49483-682 Cetirizine Hydrochloride Tablets Usp 5 Mg
SPL v1
SPL
SPL Set ID dfbddafb-9455-5805-e053-2a95a90ad0d9
Route
ORAL
Published
Effective Date 2022-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Titanium Dioxide Polyethylene Glycol, Unspecified Lactose Monohydrate Starch, Corn Povidone K30 Magnesium Stearate Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: J;219 Shape: rectangle Color: white Size: 7 mm Score: 1
Marketing Status
ANDA Active Since 2022-05-30
Description

Active ingredient (in each tablet) Cetirizine HCl 5 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Directions

adults and children 6 years and over 1 or 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 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

Description

Active ingredient (in each tablet) Cetirizine HCl 5 mg

Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding:

• if breast-feeding: Not recommended

• if pregnant: Ask a health professional before use

Section 55105-1

Purpose

Antihistamine



Section 55106-9

Active ingredient (in each tablet)



Cetirizine HCl 5 mg

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

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)

Directions

adults and children 6 years and over 1 or 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 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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

• if breast-feeding: Not recommended

• if pregnant: Ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Antihistamine



Section 55106-9 (55106-9)

Active ingredient (in each tablet)



Cetirizine HCl 5 mg

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.857358 · Updated: 2026-03-14T23:00:36.247175