Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp
SPL v2
SPL
SPL Set ID 325975c2-9f88-4500-a620-deb419f1f35c
Route
ORAL
Published
Effective Date 2019-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2019-05-31

Description

Drug Facts


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 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?

1-888-287-1915

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

NDC 49035-982-24

equate™

Compare to

Zyrtec-D® 12Hr

active ingredients*

Allergy Relief

Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-release Tablets, USP 5 mg/120 mg

Antihistamine/Nasal Decongestant

INDOOR AND OUTDOOR ALLERGIES

12

HOURS

ALLERGY & CONGESTION

12 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose
  • Sinus pressure
  • Nasal congestion

Original prescription strength

Actual Size

24

TABLETS

(4 blister cards of

6 tablets 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 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 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?

1-888-287-1915

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)

NDC 49035-982-24

equate™

Compare to

Zyrtec-D® 12Hr

active ingredients*

Allergy Relief

Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine

Hydrochloride Extended-release Tablets, USP 5 mg/120 mg

Antihistamine/Nasal Decongestant

INDOOR AND OUTDOOR ALLERGIES

12

HOURS

ALLERGY & CONGESTION

12 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose
  • Sinus pressure
  • Nasal congestion

Original prescription strength

Actual Size

24

TABLETS

(4 blister cards of

6 tablets each)


Advanced Ingredient Data


Raw Label Data

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