Allergy & Congestion Relief

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Stearic Acid Titanium Dioxide Ammonia Ferrosoferric Oxide Isopropyl Alcohol Butyl Alcohol Propylene Glycol Shellac Hydroxyethyl Cellulose (4000 Mpa.s At 1%)

Identifiers & Packaging

Pill Appearance

Imprint: 915 Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2016-08-17

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of nose or throat
- nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

at 1-800-222-1222.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 55105-1

Active ingredients (in each extended-release tablet)	Purpose
Cetirizine HCl, USP 5 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

Directions

do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 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.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Questions?

Call toll free 1-800-818-4555 weekdays

Other Information

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

Inactive Ingredients

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

When Using This Product

do not use more than directed
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.
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breast Feeding

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 24 Tablet Blister Pack Carton

*COMPARE TO THE

ACTIVE INGREDIENTS

IN ZYRTEC-D 12 HOUR^®

Original Prescription Strength

Premier

Value^®

Allergy & Congestion Relief

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-release Tablets, USP

5 mg/120 mg

Antihistamine/Nasal Decongestant

Indoor & Outdoor Allergies

12 Hour Relief of:

✓ Runny Nose ✓ Itchy Throat or Nose

✓ Sneezing ✓ Sinus Pressure

✓ Itchy, Watery Eyes ✓ Nasal Congestion

24 TABLETS

(4 blister cards of 6 tablets each)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

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 nose or throat
- nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

at 1-800-222-1222.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 55105-1 (55105-1)

Active ingredients (in each extended-release tablet)	Purpose
Cetirizine HCl, USP 5 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

Directions

do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 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.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Questions?

Call toll free 1-800-818-4555 weekdays

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

When Using This Product (When using this product)

do not use more than directed
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.
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

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

heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 24 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton)

*COMPARE TO THE

ACTIVE INGREDIENTS

IN ZYRTEC-D 12 HOUR^®

Original Prescription Strength

Premier

Value^®

Allergy & Congestion Relief

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-release Tablets, USP

5 mg/120 mg

Antihistamine/Nasal Decongestant

Indoor & Outdoor Allergies

12 Hour Relief of:

✓ Runny Nose ✓ Itchy Throat or Nose

✓ Sneezing ✓ Sinus Pressure

✓ Itchy, Watery Eyes ✓ Nasal Congestion

24 TABLETS

(4 blister cards of 6 tablets each)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Advanced Ingredient Data

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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 nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. at 1-800-222-1222 .", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "55105-1": "Active ingredients (in each extended-release tablet) Purpose Cetirizine HCl, USP 5 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant", "Directions": "do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 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. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Questions?": "Call toll free 1-800-818-4555 weekdays", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if the blister unit is broken see side panel for batch number and expiration date", "Inactive ingredients": "hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze", "When using this product": "do not use more than directed 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. you get nervous, dizzy, or sleepless symptoms do not improve within 7 days or are accompanied by fever", "If pregnant or breast-feeding": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "Ask a doctor before use if you have": "heart disease thyroid disease diabetes glaucoma high blood pressure trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.", "PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton": "*COMPARE TO THE ACTIVE INGREDIENTS IN ZYRTEC-D 12 HOUR ® Original Prescription Strength Premier Value ® Allergy & Congestion Relief Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies 12 Hour Relief of: ✓ Runny Nose ✓ Itchy Throat or Nose ✓ Sneezing ✓ Sinus Pressure ✓ Itchy, Watery Eyes ✓ Nasal Congestion 24 TABLETS (4 blister cards of 6 tablets each) INDEPENDENTLY TESTED PV SATISFACTION GUARANTEED"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information