Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Starch, Corn Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Talc Titanium Dioxide Polyethylene Glycol, Unspecified Povidone, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: R152 Shape: rectangle Color: white Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2007-12-27

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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Other Information

•
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only)
•
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
•
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 Bottle Carton

COMPARE TO THE ACTIVE

INGREDIENT IN ZYRTEC^®*

Original Prescription Strength

Premier

Value^®

24 Hour Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

✓
Sneezing
✓
Runny nose
✓
Itchy, watery eyes
✓
Itchy throat or nose

90

Tablets

10 mg Each

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Other Information (OTHER INFORMATION)

•
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only)
•
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
•
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 Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton)

COMPARE TO THE ACTIVE

INGREDIENT IN ZYRTEC^®*

Original Prescription Strength

Premier

Value^®

24 Hour Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

✓
Sneezing
✓
Runny nose
✓
Itchy, watery eyes
✓
Itchy throat or nose

90

Tablets

10 mg Each

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "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": "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 Keep the carton. It contains important information. See end panel for expiration date. Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087", "OTHER INFORMATION": "• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only) • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) • 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 Bottle Carton": "COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC ® * Original Prescription Strength Premier Value ® 24 Hour Allergy Relief Cetirizine HCl Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: ✓ Sneezing ✓ Runny nose ✓ Itchy, watery eyes ✓ Itchy throat or nose 90 Tablets 10 mg Each INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information