Cetirizine 10mg Tablets, Allergy Tablets Drug Facts

Cetirizine 10mg Tablets, Allergy Tablets Drug Facts
SPL v2
SPL
SPL Set ID abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f
Route
ORAL
Published
Effective Date 2010-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Cellulose, Microcrystalline Magnesium Stearate Hypromellose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: M;C37 Shape: bullet Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2010-01-01

Description

(in each Tablet) Cetirizine HCI 10mg

Purpose

ANTIHISTAMINE 24 Hour Relief of Indoor and Outdoor Allergies


Medication Information

Purpose
ANTIHISTAMINE

24 Hour Relief of Indoor and Outdoor Allergies

Description

(in each Tablet) Cetirizine HCI 10mg

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

Warnings
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 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

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.
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

Active Ingredient
(in each Tablet)

Cetirizine HCI 10mg

Ask A Doctor Before Use
if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

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 Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use

if you are taking tranquilizers or sedatives.

Package Label and Principal Display Panel
NDC 12634-987-71

CETIRIZINE HCI

Antihistamine

Indoor and Outdoor Allergies


24 Hour Relief of Sneezing, Runny Nose, Itchy,

Watery Eyes, Itchy Throat or Nose.

Allergy Tablets

RejuviLife

30 Tablets

10 MG



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

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin


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

24 Hour Relief of Indoor and Outdoor Allergies

Warnings (WARNINGS)
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 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

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.
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

Active Ingredient (ACTIVE INGREDIENT)
(in each Tablet)

Cetirizine HCI 10mg

Ask A Doctor Before Use (Ask a Doctor before use)
if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product (When using this product)
  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

Stop Use and Ask A Doctor (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 Poison Control Center right away.

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

if you are taking tranquilizers or sedatives.

Package Label and Principal Display Panel (PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL)
NDC 12634-987-71

CETIRIZINE HCI

Antihistamine

Indoor and Outdoor Allergies


24 Hour Relief of Sneezing, Runny Nose, Itchy,

Watery Eyes, Itchy Throat or Nose.

Allergy Tablets

RejuviLife

30 Tablets

10 MG



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

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin


Advanced Ingredient Data


Raw Label Data

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