Allergy Relief

Allergy Relief
SPL v5
SPL
SPL Set ID 9cee1738-ed64-4b4b-9e45-3a340cb68056
Route
ORAL
Published
Effective Date 2020-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose, Unspecified Form Magnesium Stearate Polyethylene Glycol, Unspecified Povidone Titanium Dioxide Hypromellose, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2020-09-23

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 42229-5

Drug Facts

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 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.

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 Information
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

colloidal silicon dioxide*, croscarmellose sodium*, hypromellose, lactose, magnesium stearate, maize starch*, microcrystalline cellulose*, polyethylene glycol, povidone*, titanium dioxide

*containes one or more of these ingrdients

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to the active ingredient

in Zyrtec®*

Allergy Relief

Cetirizine HCl 10mg

*This product is not manufactured or distributed

by McNeil Consumer Healthcare, owner of the

registered trademark Zyrtec®

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
If Pregnant Or Breast Feeding
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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 42229-5 (42229-5)

Drug Facts

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 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.

Purpose

Antihistamine

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 Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide*, croscarmellose sodium*, hypromellose, lactose, magnesium stearate, maize starch*, microcrystalline cellulose*, polyethylene glycol, povidone*, titanium dioxide

*containes one or more of these ingrdients

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient

in Zyrtec®*

Allergy Relief

Cetirizine HCl 10mg

*This product is not manufactured or distributed

by McNeil Consumer Healthcare, owner of the

registered trademark Zyrtec®

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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)