Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Manufacturer
Strategic Sourcing Services LLC | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2025-05-09
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:26

Label at a glance#

ProductFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure12 sections

Indications and 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

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 Other information safety sealed: do not use i...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

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

Do not use

  • 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 a 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 (1-800-222-1222) 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 age
 do not use
 adults 65 years of age and older
 ask a doctor
 consumers with kidney disease
 ask a doctor

Other information

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store at 20-25°C (68-77°F).
  • Meets USP dissolution test 7

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

 IMPORTANT: READ THE DIRECTIONS AND WARNINGS BEFORE USE. KEEP THE CARTON, IT CONTAINS IMPORTANT INFORMATION.   

©2023 McKesson Corporation

Distributed by:  McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141

www.fosterandthrive.com


Product of India

Rev. 04/25

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70677-1278-1

Foster ξ Thrive™

12 HOUR

COMPARE TO THE ACTIVE INGREDIENTS
IN ALLEGRA-D® 12 HOUR
ALLERGY & CONGESTION TABLETS*
Allergy & Congestion-D

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP 60 mg/120 mg

ANTIHISTAMINE & NASAL DECONGESTANT
Non-Drowsy

INDOOR / OUTDOOR RELIEF OF

     •     Nasal and Sinus Congestion

           Due to Colds or Allergies

    •     Sneezing; Runny Nose; Itchy,

           Watery Eyes and Itchy Nose or

           Throat Due to Allergies

ACTUAL SIZE

20 EXTENDED RELEASE TABLETS



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton



 

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Product concept, Relation, Version table
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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1278FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC]1Unmatched20250523_af4604bd-6a9f-4af6-aefb-479e85b5b8e2.zip

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Product NDC, Package NDC table
Product NDCPackage NDC
70677-127870677-1278-1, 70677-1278-2

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a96a6013-bb93-4d16-bbe1-cd5ba39e7353af4604bd-6a9f-4af6-aefb-479e85b5b8e22025-11-06WarningsExact identifier
spl set id: af4604bd-6a9f-4af6-aefb-479e85b5b8e2

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