Allergy Relief- Cetirizine Hcl 10 Mg

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: CTN;10 Shape: bullet Color: white Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2025-06-09

Medication Information

Purpose

Antihistamine

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 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 sedatives or tranquilizers.

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 51945-4

Section 53414-9

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use

Warnings:

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.

Directions

Adults and children 6 years of age and older: 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.

Children under 6 years of age: Ask a doctor.

Adults 65 years of age and older: Ask a doctor.

Consumers with liver or kidney disease: Ask a doctor

Other Lnformation

Store between 20°Cto 25°C(68°F to 77°F)

Inactive Ingredients

Lactose, Povidone, Maize Starch, Magnesium Stearate, Titanium Dioxide, Hypromellose, Polyethylene Glycol

Questions Or Comments?

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg

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

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 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 sedatives or tranquilizers.

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 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

• if breast-feeding: not recommended

• if pregnant: ask a health professional before use

Purpose

Antihistamine

Warnings:

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.

Directions

Adults and children 6 years of age and older: 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.

Children under 6 years of age: Ask a doctor.

Adults 65 years of age and older: Ask a doctor.

Consumers with liver or kidney disease: Ask a doctor

Other Lnformation (Other lnformation)

Store between 20°Cto 25°C(68°F to 77°F)

Inactive Ingredients

Lactose, Povidone, Maize Starch, Magnesium Stearate, Titanium Dioxide, Hypromellose, Polyethylene Glycol

Questions Or Comments? (Questions or Comments?)

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Cetirizine HCl 10 mg

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "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 sneezing itchy, watery eyes itching of the nose or throat", "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.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "53414-9": "If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use", "Purpose": "Antihistamine", "Warnings:": "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.", "Directions": "Adults and children 6 years of age and older: 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. Children under 6 years of age: Ask a doctor. Adults 65 years of age and older: Ask a doctor. Consumers with liver or kidney disease: Ask a doctor", "Other lnformation": "Store between 20°Cto 25°C(68°F to 77°F)", "Inactive Ingredients": "Lactose, Povidone, Maize Starch, Magnesium Stearate, Titanium Dioxide, Hypromellose, Polyethylene Glycol", "Questions or Comments?": "Call 1 (718) 337-8733 or visit support@nuvicare.com", "Active Ingredient (in each tablet)": "Cetirizine HCl 10 mg"}

Allergy Relief- Cetirizine Hcl 10 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information