033 Cetirizine Hcl Tablets

033 Cetirizine Hcl Tablets
SPL v6
SPL
SPL Set ID a75cd557-e19b-fdd4-e053-2a95a90a8097
Route
ORAL
Published
Effective Date 2022-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Microcrystalline Cellulose Water Croscarmellose Sodium Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2020-05-01

Description

Cetirizine HCl, USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl, USP 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 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

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.

Package Label

Other Information

store between 20º -25ºC (68º -77ºF)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white OY-58900, purified water

Questions Or Comments?

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

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
Manufacturing Information

Manufactrued for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00015

V1 RE22HND

Stop Use and Ask A Doctor If

an allergic reaction 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).

Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

Ask A Doctor Before Use If You Have

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

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 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

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.

Package Label

Other Information (Other information)

store between 20º -25ºC (68º -77ºF)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white OY-58900, purified water

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

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
Manufacturing Information

Manufactrued for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00015

V1 RE22HND

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction 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).

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

Cetirizine HCl, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking tranquilizers or sedatives.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)