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

Purpose

Antihistamine

Description

Drug Facts


Medication Information

Active Ingredient

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
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
  • 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

Description

Drug Facts

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®

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.

Questions Or Comments?

1-888-333-9792

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.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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
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

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®

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.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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.

Advanced Ingredient Data


Raw Label Data

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