Cabinet Allergy Relief Refill, Cetirizine Hci 10 Mg

SPL v1

SPL

SPL Set ID 0eaf9d27-e221-4cdd-97bc-478c775e3d67

Route

ORAL

Published

Effective Date 2025-06-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Starch, Corn Polyethylene Glycol, Unspecified Povidone, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2025-06-25

Description

Cetirizine HCl 10mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10mg

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • itchy watery eyes• sneezing• itching of the nose or throat

Warnings

Directions

adults & children 6 years & over	one 10 mg caplet once daily; do not take more than one 10 mg caplet in 24 hours. A 5 mg product may be appropriate for less severe symptoms
adults 65 years & over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

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.

Drug Facts

Other Information

• store between 20°–25°C (68° –77°F)

Package Labeling:

Inactive Ingredients

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

Questions Or Comments?

908-242-6108

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.

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)

Active Ingredient (in Each Caplet)

Cetirizine HCl 10mg

Ask A Doctor Before Use If You Have

liver or kidny disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Structured Label Content

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • itchy watery eyes• sneezing• itching of the nose or throat

Purpose

Antihistamine

Warnings

Directions

adults & children 6 years & over	one 10 mg caplet once daily; do not take more than one 10 mg caplet in 24 hours. A 5 mg product may be appropriate for less severe symptoms
adults 65 years & over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Do Not Use (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.

Drug Facts

Other Information (Other information)

• store between 20°–25°C (68° –77°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

908-242-6108

When Using This Product (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 (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 pregnant or breast-feeding,)

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use.

Keep Out of Reach of Children. (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)

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))

Cetirizine HCl 10mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidny disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

[{"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • itchy watery eyes• sneezing• itching of the nose or throat ", "Purpose": "Antihistamine", "Directions": " adults & children 6 years & over one 10 mg caplet once daily; do not take more than one 10 mg caplet in 24 hours. A 5 mg product may be appropriate for less severe symptoms adults 65 years & over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "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.", "Other information": "• store between 20°–25°C (68° –77°F)", "Inactive ingredients": "hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide", "Questions or comments?": "908-242-6108", "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.", "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)", "Active Ingredient (in each caplet)": "Cetirizine HCl 10mg", "Ask a doctor before use if you have": "liver or kidny disease. Your doctor should determine if you need a different dose.", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:27.634624 · Updated: 2026-03-14T23:09:13.832086