Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Hydroxypropyl Cellulose (type H) Hypromelloses Magnesium Stearate Cellulose, Microcrystalline 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 2017-05-02

Medication Information

Purpose

Antihistamine

Nasal Decongestant

Description

Cetirizine HCl, USP 5 mg Pseudoephedrine HCl, USP 120 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
- nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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 after 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 inner safety seal is open or torn
see side panel for batch number and expiration date

Active Ingredients

Cetirizine HCl, USP 5 mg

Pseudoephedrine HCl, USP 120 mg

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.

Keep Out of Reach of Children.

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

Principal Display Panel Showbox

LEADER

NDC 70000-0163-1

Allergy Relief-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

5 mg/120 mg

Antihistamine | Nasal Decongestant

Original Prescription Strength

COMPARE TO ZYRTEC-D^® 12 HOUR

active ingredients*

12 Hour Relief of:

• Sinus Pressure • Nasal Congestion

• Runny Nose • Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

24 EXTENDED-RELEASE TABLETS (4 blister cards of 6 tablets each)

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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

Purpose

Antihistamine

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 after 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 inner safety seal is open or torn
see side panel for batch number and expiration date

Active Ingredients (Active ingredients)

Cetirizine HCl, USP 5 mg

Pseudoephedrine HCl, USP 120 mg

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.

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.

Principal Display Panel Showbox (Principal Display Panel - Showbox)

LEADER

NDC 70000-0163-1

Allergy Relief-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

5 mg/120 mg

Antihistamine | Nasal Decongestant

Original Prescription Strength

COMPARE TO ZYRTEC-D^® 12 HOUR

active ingredients*

12 Hour Relief of:

• Sinus Pressure • Nasal Congestion

• Runny Nose • Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

24 EXTENDED-RELEASE TABLETS (4 blister cards of 6 tablets each)

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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

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 the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose", "Purpose": "Antihistamine 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 after 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 inner safety seal is open or torn see side panel for batch number and expiration date", "Active ingredients": "Cetirizine HCl, USP 5 mg Pseudoephedrine HCl, USP 120 mg", "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.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Principal Display Panel - Showbox": "LEADER NDC 70000-0163-1 Allergy Relief-D Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 5 mg/120 mg Antihistamine | Nasal Decongestant Original Prescription Strength COMPARE TO ZYRTEC-D ® 12 HOUR active ingredients* 12 Hour Relief of: • Sinus Pressure • Nasal Congestion • Runny Nose • Sneezing • Itchy, Watery Eyes • Itchy Throat or Nose 24 EXTENDED-RELEASE TABLETS (4 blister cards of 6 tablets each)", "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.", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}