Allergy + Sinus - Food and Drug Administration

12

EXTENDED RELEASE TABLETS

? Sneezing ? Itchy, Watery Eyes ? Runny Nose ? Itchy Nose or Throat

NASAL CONGESTION+ SINUS PRESSURE

30049288

Allergy + Sinus

Actual Size

RELIEF

HOUR

1 2

30049288

Extended-Release Tablets

Pseudoephedrine HCl 120 mg/nasal decongestant

Cetirizine HCl 5 mg/antihistamine

OUTDOOR ALLERGIES

INDOOR +

Original Prescription Strength

NDC 50580-728-12

Extended-Release Tablets

Pseudoephedrine HCl 120 mg/nasal decongestant

Cetirizine HCl 5 mg/antihistamine

Allergy + Sinus

1 2

EXTENDED RELEASE TABLETS

30049288

Made in Belgium

Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division Fort Washington, PA 19034 USA ?J&JCI 2021

U.S. Patent Nos. 6469009, 7014867, 7226614

The trade dress of this ZYRTEC? package is subject to trademark protection.

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

Drug Facts

Active ingredients (in each extended release tablet)

Purpose

Cetirizine HCl 5 mg ............................................................. Antihistamine

Pseudoephedrine HCl 120 mg .................................... Nasal decongestant

Uses

I temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: I runny nose I sneezing I itchy, watery eyes I itching of the nose or throat I nasal congestion

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

Warnings

Do not use I if you have ever had an allergic reaction to this product or any of its

ingredients or to an antihistamine containing hydroxyzine. I 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.

Ask a doctor before use if you have

I heart disease I thyroid disease I diabetes

I glaucoma

I high blood pressure

I trouble urinating due to an enlarged prostate gland

I liver or kidney disease. Your doctor should determine if you need a

different dose.

Drug Facts (continued)

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

When using this product I do not use more than directed I drowsiness may occur I avoid alcoholic drinks I alcohol, sedatives, and tranquilizers may increase drowsiness I be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if I an allergic reaction to this product occurs. Seek medical help right away. I you get nervous, dizzy, or sleepless I symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding: I if breast-feeding: not recommended I 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. (1-800-222-1222)

Directions I do not break or chew tablet; swallow tablet whole

adults and children 12 years and over

adults 65 years and over

children under 12 years of age

consumers with liver or kidney disease

take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. ask a doctor ask a doctor ask a doctor

Other information I store between 20? to 25?C (68? to 77?F)

I do not use if blister unit is torn or broken

LOT EXP MM / YYYY



Drug Facts (continued) Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose

monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

3 00450 20427 1

This label may not be the latest approved by FDA. For current labeling information, please visit

30049289_ZYRTEC_D_Allergy+Sinus_24ct_Carton_R5.pdf 1 10/18/21 4:57 PM

24

EXTENDED RELEASE TABLETS

? Sneezing ? Itchy, Watery Eyes ? Runny Nose ? Itchy Nose or Throat

NASAL CONGESTION + SINUS PRESSURE

30049289

Allergy + Sinus

Actual Size

RELIEF

HOUR

1 2

30049289

Extended-Release Tablets

Pseudoephedrine HCl 120 mg/nasal decongestant

Cetirizine HCl 5 mg/antihistamine

OUTDOOR ALLERGIES

INDOOR +

Original Prescription Strength

NDC 50580-728-24

24

EXTENDED RELEASE TABLETS

Cetirizine HCl 5 mg/antihistamine Pseudoephedrine HCl 120 mg/nasal decongestant Extended-Release Tablets

Allergy + Sinus

The trade dress of this ZYRTEC? package 30049289 is subject to trademark protection. U.S. Patent Nos. 6469009, 7014867, 7226614

LOT EXP MM / YYYY

Cetirizine HCl 5 mg/antihistamine Pseudoephedrine HCl 120 mg/nasal decongestant Extended-Release Tablets

Allergy + Sinus

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

Drug Facts

Active ingredients (in each extended release tablet)

Purpose

Cetirizine HCl 5 mg ............................................................. Antihistamine

Pseudoephedrine HCl 120 mg .................................... Nasal decongestant

Uses

I temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: I runny nose I sneezing I itchy, watery eyes I itching of the nose or throat I nasal congestion

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

Warnings

Do not use

I if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

I 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.

Ask a doctor before use if you have

I heart disease I thyroid disease I diabetes

I glaucoma

I high blood pressure

I trouble urinating due to an enlarged prostate gland

I liver or kidney disease. Your doctor should determine if you need a

different dose.

Drug Facts (continued)

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

When using this product I do not use more than directed I drowsiness may occur I avoid alcoholic drinks I alcohol, sedatives, and tranquilizers may increase drowsiness I be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if I an allergic reaction to this product occurs. Seek medical help right away. I you get nervous, dizzy, or sleepless I symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding: I if breast-feeding: not recommended I 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. (1-800-222-1222)

Directions I 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

Other information I store between 20? to 25?C (68? to 77?F)

I do not use if blister unit is torn or broken

Drug Facts (continued) Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose

monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Made in Belgium

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division

Fort Washington, PA 19034 USA

?J&JCI 2021



3 00450 20424 0

This label may not be the latest approved by FDA. For current labeling information, please visit

This label may not be the latest approved by FDA. For current labeling information, please visit

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