Cetirizine Hydrochloride Tablets

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:51:31

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

Purpose

Antihistamine

Uses

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. itching of the nose or throat .

Warnings

Warnings

Directions And Dosage

Directions

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 Label Information

Other information

1. store between 20° to 25°C (68° to 77°F) Repackaged By: Preferred Pharmaceuticals Inc.

Inactive ingredients

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

Questions?

call 1-888-375-3784 . NDC 68788-8435

Bottle Label

Products

NDC Codes

Ingredients

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, 10mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. itching of the nose or throat .

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

1. store between 20° to 25°C (68° to 77°F) Repackaged By: Preferred Pharmaceuticals Inc.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784 . NDC 68788-8435

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
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Legacy File Index

FolderFileDate
otc8efeffe6-f264-4a44-a348-63a33f9c6d25.xml2026-03-27
otcf859a35b-2461-42aa-bbc9-7a75ec8c2881.xml2025-02-27
otc5b3ccfe9-81d1-411a-96ab-5a98275d8566.xml2024-03-27
otc14A885E5-5E75-4A18-B5BC-6AAA748712DB-00.jpg2023-05-03
otc14a885e5-5e75-4a18-b5bc-6aaa748712db.xml2023-05-03