Zyrtec-d® - DailyMed Details

Zyrtec-d®

SPL v1

SPL

SPL Set ID 3c9d819d-0f3f-4c76-9770-cf004b10299a

Route

ORAL

Published

Effective Date 2012-05-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: Zyrtec;D Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

NDA Active Since 2008-03-28

Description

Drug Facts

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine

Nasal decongestant

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.

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

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if individual blister unit is open or torn
see back panel for lot number and expiration date

Inactive Ingredients

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

Principal Display Panel

NDC 54868-5879-0

Original Prescription Strength

ZYRTEC-D^®

Cetirizine HCl 5 mg/antihistamine

Pseudoephedrine HCl 120 mg/nasal decongestant

Extended Release Tablets

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12

hour

Relief of

Sneezing
Runny Nose
Sinus Pressure

Itchy, Watery Eyes
Itchy Throat or Nose
Nasal Congestion

24

Extended

Release

Tablets

(individual Blisters)

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.

Active Ingredients (in Each Extended Release Tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

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.

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) (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

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if individual blister unit is open or torn
see back panel for lot number and expiration date

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)

NDC 54868-5879-0

Original Prescription Strength

ZYRTEC-D^®

Cetirizine HCl 5 mg/antihistamine

Pseudoephedrine HCl 120 mg/nasal decongestant

Extended Release Tablets

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12

hour

Relief of

Sneezing
Runny Nose
Sinus Pressure

Itchy, Watery Eyes
Itchy Throat or Nose
Nasal Congestion

24

Extended

Release

Tablets

(individual Blisters)

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.

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended release tablet))

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Advanced Ingredient Data

[{"name": "Cetirizine", "unii": "YO7261ME24", "classCode": "ACTIM", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "Pseudoephedrine", "unii": "7CUC9DDI9F", "classCode": "ACTIM", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "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. (1-800-222-1222)", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "53414-9": "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.", "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) (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", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if individual blister unit is open or torn see back panel for lot number and expiration date", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "NDC 54868-5879-0 Original Prescription Strength ZYRTEC-D ® Cetirizine HCl 5 mg /antihistamine Pseudoephedrine HCl 120 mg /nasal decongestant Extended Release Tablets Indoor & Outdoor Allergies ALLERGY & CONGESTION 12 hour Relief of Sneezing Runny Nose Sinus Pressure Itchy, Watery Eyes Itchy Throat or Nose Nasal Congestion 24 Extended Release Tablets (individual Blisters)", "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.", "Active ingredients (in each extended release tablet)": "Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:28.532924 · Updated: 2026-03-14T22:53:08.969860