Zyrtec 1s Blister, 1 Tablet Per Blister, 6 Blisters Per Box

Zyrtec 1s Blister, 1 Tablet Per Blister, 6 Blisters Per Box
SPL v3
SPL
SPL Set ID 3a595eb8-2409-4598-8704-ab59b57bd062
Route
ORAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ZYRTEC;10;MG Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
NDA Active Since 2019-01-20

Description

Cetrizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetrizine 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
Directions

 adults and children

6 years and over

one 10mg tablet  once daily; do not take more than one 10mg tabelt 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

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

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if pouch is torn or damaged
  • meets USP Dissolution Test 2
Package Labeling:

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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 reastion 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)

Ask A Doctor Before Use If You Have

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

Active Ingredient ((in Each Tablet)) 

Cetrizine HCl 10 mg

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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

Directions

 adults and children

6 years and over

one 10mg tablet  once daily; do not take more than one 10mg tabelt 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

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

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if pouch is torn or damaged
  • meets USP Dissolution Test 2
Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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 reastion 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)

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.

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

Cetrizine HCl 10 mg

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


Raw Label Data

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