FDA.reportPublic FDA data

12HR ALLERGY AND CONGESTION RELIEF

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:49

Label at a glance#

Product12HR ALLERGY AND CONGESTION RELIEF
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP, 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Use(s)

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 relives 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

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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.
  • if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
  • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

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 agedo not use
adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: 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) store between 20° to 25°C (68° to 77°F)
  • FDA approved dissolution test specifications differ from USP.
  • FDA approved organic impurities test procedure differs from USP Procedure 1.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

Questions?

OTC - QUESTIONS SECTION

Call toll-free weekdays 9 AM to 8 PM EST Call 1-888-375-3784

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister Carton

Carton
Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-063412HR ALLERGY AND CONGESTION RELIEF (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LEADER/ CARDINAL HEALTH 110, INC.]2Unmatched20230526_2b9e741d-3685-94a8-3622-c8f9f6fbf5df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-063470000-0634-2, 70000-0634-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
Croscarmellose SodiumM28OL1HH48IACT
Ferric Oxide YellowEX438O2MRTIACT
Silicon DioxideETJ7Z6XBU4IACT
Magnesium Stearate70097M6I30IACT
Polyethylene Glycol 400B697894SGQIACT
Hypromellose 2208 (100000 Mpa.S)VM7F0B23ZIIACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)8VAB711C5EIACT
Hypromellose 2910 (6 Mpa.S)0WZ8WG20P6IACT
Polyethylene Glycol 8000Q662QK8M3BIACT
Starch, CornO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e927f1c6-86b8-c088-3069-013b8cd963332b9e741d-3685-94a8-3622-c8f9f6fbf5df2025-07-27WarningsExact identifier
spl set id: 2b9e741d-3685-94a8-3622-c8f9f6fbf5df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.