Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Set ID
1ed05c85-7a1c-440d-a5d7-e229528cedcd
Manufacturer
walgreens | Sun Pharmaceutical Industries Limited
Effective date
2024-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:13

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 the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Other Label Information

Other information

do not use if carton is opened or if individual blister units are torn or opened store between 20° to 25°C (68° to 77°F) Meets dissolution test 6

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Questions or comments?

Call toll-free 1-800-818-4555 weekdays

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

ORIGINAL PRESCRIPTION STRENGTH Walgreens Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion †† •WALGREENS PHARMACIST RECOMMENDED † • NON-DROWSY Allergy Relief D12 ALLERGY & CONGESTION FEXOFENADINE HCl 60 mg /ANTIHISTAMINE PSEUDOEPHEDRINE HCl 120 mg / NASAL DECONGESTANT 12 Hour Extended-Release Tablets, USP Indoor/outdoor relief of nasal & sinus congestion due to colds or allergies Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies 30 EXTENDED-RELEASE TABLETS DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN ACTUAL SIZE

Products

NDC Codes

Ingredients

NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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 the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Other information

STORAGE AND HANDLING SECTION

do not use if carton is opened or if individual blister units are torn or opened store between 20° to 25°C (68° to 77°F) Meets dissolution test 6

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-818-4555 weekdays

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH Walgreens Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion †† •WALGREENS PHARMACIST RECOMMENDED † • NON-DROWSY Allergy Relief D12 ALLERGY & CONGESTION FEXOFENADINE HCl 60 mg /ANTIHISTAMINE PSEUDOEPHEDRINE HCl 120 mg / NASAL DECONGESTANT 12 Hour Extended-Release Tablets, USP Indoor/outdoor relief of nasal & sinus congestion due to colds or allergies Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies 30 EXTENDED-RELEASE TABLETS DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN ACTUAL SIZE

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/1ed05c85-7a1c-440d-a5d7-e229528cedcd/4f95c9cf-97d7-4cb3-a78a-5e3e91e86550.xml
XML SHA-256
31127441b59d922cd1cf845fd0240785bca6e8c2f7c16b1852970dd25e94bb9a
XML bytes
32744

Legacy File Index

FolderFileDate
otc4f95c9cf-97d7-4cb3-a78a-5e3e91e86550.xml2024-06-01
otcacf43ee3-0615-44af-9d2a-54052c9b3af1.xml2019-02-20
otcfexofenadine-01.jpg2019-02-20