DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Betadex Anhydrous Citric Acid Silicon Dioxide Crospovidone (35 .mu.m) .alpha.-tocopherol, Dl- Hydroxypropyl Cellulose (110000 Wamw) Magnesium Stearate Maltodextrin Mannitol Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Sodium Bicarbonate Sodium Starch Glycolate Type A Potato Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: CE;10 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2021-02-12

Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each tablet) Cetirizine hydrochloride 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

Tablet melts in mouth. Can be taken with or without water.

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.

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Other Information

store between 20° to 25°C (68° to 77°F). Avoid high humidity.
do not use if carton or blister unit is opened or broken
see side panel for lot number and expiration date

Inactive Ingredients

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by: AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

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)

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.

Package Label Principal Display Panel 10 Mg (24 Orally Disintegrating Tablets) Blister Carton

Healthy Living^™

NDC 58602-860-76

*Compare to the active

ingredient of Zyrtec^® Allergy

Original Prescription Strength

Cetirizine Hydrochloride

Orally Disintegrating Tablets, USP 10 mg

Antihistamine

Allergy

Dissolve Tabs

Melts In Your Mouth

ORANGE FLAVOR

Indoor + Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size

24 Orally Disintegrating Tablets

10 mg each

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

Tablet melts in mouth. Can be taken with or without water.

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.

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Other Information (Other information)

store between 20° to 25°C (68° to 77°F). Avoid high humidity.
do not use if carton or blister unit is opened or broken
see side panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by: AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

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)

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.

Package Label Principal Display Panel 10 Mg (24 Orally Disintegrating Tablets) Blister Carton (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton)

Healthy Living^™

NDC 58602-860-76

*Compare to the active

ingredient of Zyrtec^® Allergy

Original Prescription Strength

Cetirizine Hydrochloride

Orally Disintegrating Tablets, USP 10 mg

Antihistamine

Allergy

Dissolve Tabs

Melts In Your Mouth

ORANGE FLAVOR

Indoor + Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size

24 Orally Disintegrating Tablets

10 mg each

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BETADEX", "unii": "JV039JZZ3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (35 .MU.M)", "unii": "40UAA97IT9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL, DL-", "unii": "7QWA1RIO01", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (110000 WAMW)", "unii": "5Y0974F5PW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 101", "unii": "7T9FYH5QMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "Tablet melts in mouth. Can be taken with or without water. 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.", "Drug Facts": "Active ingredient (in each tablet) Cetirizine hydrochloride USP 10 mg", "Other information": "store between 20° to 25°C (68° to 77°F). Avoid high humidity. do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date", "Inactive ingredients": "betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016", "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)", "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.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton": "Healthy Living ™ NDC 58602-860-76 *Compare to the active ingredient of Zyrtec ® Allergy Original Prescription Strength Cetirizine Hydrochloride Orally Disintegrating Tablets, USP 10 mg Antihistamine Allergy Dissolve Tabs Melts In Your Mouth ORANGE FLAVOR Indoor + Outdoor Allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Actual Size 24 Orally Disintegrating Tablets 10 mg each"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information