Allergy Relief

Allergy Relief
SPL v4
SPL
SPL Set ID b064f4ba-d5ff-c503-e053-2995a90ab1ec
Route
ORAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Lactose Monohydrate Microcrystalline Cellulose Water Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: oval Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2020-09-21

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine


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 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.

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

Active Ingredient

Cetirizine HCl 10 mg

Other Lnfonnation
  • Store between 20°Cto 25°C(68°F to 77°F)
Inactive Ingredients

Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch, titanium dioxide

Questions Or Comments?

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST.


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 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.

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

Active Ingredient

Cetirizine HCl 10 mg

Other Lnfonnation (Other lnfonnation)
  • Store between 20°Cto 25°C(68°F to 77°F)
Inactive Ingredients

Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch, titanium dioxide

Questions Or Comments? (Questions or Comments?)

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)