Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Manufacturer
EQUATE (WAL-MART STORES, INC.) | Sun Pharmaceutical Industries Limited
Effective date
2019-05-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:35

Key Label Information

Uses

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

Warnings

Warnings

Directions And Dosage

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

Other Label 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

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Questions?

1-888-287-1915

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)

Products

NDC Codes

Ingredients

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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 INGREDIENT SECTION

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otccetirizine-01.jpg2019-05-31
otcef4fc264-bf2e-404d-95a0-ff92ed0bc347.xml2019-05-31