Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b326dacc-6123-47a7-9fde-6909db1d780b
Route
ORAL
Published
Effective Date 2018-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: R152 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2017-09-01

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.

Questions?

Call 1-800-406-7984

Other Information
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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 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.

Principal Display Panel 10 Mg Tablet Blister Pack Carton

COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC®*

NDC 55319-939-54

FAMILY

wellness™

100% SATISFACTION

OR YOUR MONEY BACK

GUARANTEED

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg/Antihistamine


Indoor & Outdoor Allergies

Relief of:

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Throat or Nose

24

HOUR

Original Prescription Strength

14 TABLETS 10 mg EACH

ACTUAL SIZE

OTC

network


Structured Label Content

Uses (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 (PURPOSE)

Antihistamine

Directions (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.

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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 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 If You Are (Ask a doctor or pharmacist before use if you are)

Taking tranquilizers or sedatives.

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC®*

NDC 55319-939-54

FAMILY

wellness™

100% SATISFACTION

OR YOUR MONEY BACK

GUARANTEED

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg/Antihistamine


Indoor & Outdoor Allergies

Relief of:

• Sneezing

• Itchy, Watery Eyes

• Runny Nose

• Itchy Throat or Nose

24

HOUR

Original Prescription Strength

14 TABLETS 10 mg EACH

ACTUAL SIZE

OTC

network


Advanced Ingredient Data


Raw Label Data

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