Zyrtec-d

Zyrtec-d
SPL v5
SPL
SPL Set ID f1ecf9ba-1c03-7fb7-e053-2a95a90a875a
Route
ORAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Croscarmellose Sodium Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ZYRTEC;D Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
NDA Active Since 2023-02-28

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 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

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. (1-800-222-1222)

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Section 55105-1
Active ingredients (in each extended release tablet) Purpose
Cetirizine HCl 5 mg Antihistamine
Pseudoephedrine HCl 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 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if blister unit is torn or broken
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel

Original Prescription Strength

New look

Same

relief



NDC 50580-719-24

ZYRTEC-D ®

Cetirizine HCl 5 mg/antihistamine

Pseudoephedrine HCl 120 mg/ nasal decongestant

Extended Release Tablets

Indoor &

Outdoor

Allergies

ALLERGY

+ SINUS

NASAL CONGESTION

+ SINUS PRESSURE

12

Hour

relief of

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Actual Size

24

Extended

Release

Tablets

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
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.

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)

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. (1-800-222-1222)

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Section 55105-1 (55105-1)
Active ingredients (in each extended release tablet) Purpose
Cetirizine HCl 5 mg Antihistamine
Pseudoephedrine HCl 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 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if blister unit is torn or broken
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Original Prescription Strength

New look

Same

relief



NDC 50580-719-24

ZYRTEC-D ®

Cetirizine HCl 5 mg/antihistamine

Pseudoephedrine HCl 120 mg/ nasal decongestant

Extended Release Tablets

Indoor &

Outdoor

Allergies

ALLERGY

+ SINUS

NASAL CONGESTION

+ SINUS PRESSURE

12

Hour

relief of

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Actual Size

24

Extended

Release

Tablets

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
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.

Advanced Ingredient Data


Raw Label Data

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