Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp
SPL v5
SPL
SPL Set ID c24f3760-70e0-410f-bf80-6d0cadcd61b9
Route
ORAL
Published
Effective Date 2024-12-16
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 2017-05-02

Description

Important: Read all product information before using. Keep this box for important information.


Medication Information

Description

Important: Read all product information before using. Keep this box for important information.

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
Section 42229-5

Important: Read all product information before using. Keep this box for important information.

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) Purposes
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) (certain 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 carton is opened or if the blister unit is broken
  • see side panel for lot 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 12 Tablet Blister Card Carton

Compare To

the active ingredients of

Zyrtec-D®12Hr

NDC 51660-940-12

ohm®

12

Hour

Allergy Relief

Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-Release Tablets, USP 5 mg/120 mg

Antihistamine/Nasal Decongestant

12 Hour Relief of:

   • Sneezing • Itchy, Watery Eyes • Sinus Pressure

   • Runny Nose • Itchy Throat or Nose

   • Nasal Congestion

Indoor & Outdoor Allergies

ALLERGY & SINUS

12 Tablets (2 blister cards of 6 tablets each)

Original Prescription Strength


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
Section 42229-5 (42229-5)

Important: Read all product information before using. Keep this box for important information.

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) Purposes
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) (certain 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 carton is opened or if the blister unit is broken
  • see side panel for lot 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 12 Tablet Blister Card Carton (PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton)

Compare To

the active ingredients of

Zyrtec-D®12Hr

NDC 51660-940-12

ohm®

12

Hour

Allergy Relief

Nasal Decongestant

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended-Release Tablets, USP 5 mg/120 mg

Antihistamine/Nasal Decongestant

12 Hour Relief of:

   • Sneezing • Itchy, Watery Eyes • Sinus Pressure

   • Runny Nose • Itchy Throat or Nose

   • Nasal Congestion

Indoor & Outdoor Allergies

ALLERGY & SINUS

12 Tablets (2 blister cards of 6 tablets each)

Original Prescription Strength


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)