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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP

Approved
Approval ID

af4604bd-6a9f-4af6-aefb-479e85b5b8e2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 9, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1278
Application NumberANDA209116
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2025
FDA Product Classification

INGREDIENTS (13)

FEXOFENADINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/9/2025

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

** 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 andPseudoephedrine 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

20EXTENDED RELEASE TABLETS

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


INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/9/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/9/2025

Drug Facts

Active ingredients (in each tablet)


Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/9/2025

Purpose

Antihistamine
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/9/2025

Warnings

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/9/2025

Ask a doctor before use if you have

  • 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.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/9/2025

When using this product

*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).

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/9/2025

Stop use and ask a doctor if

  • 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

LOINC: 53414-9Updated: 5/9/2025

**If pregnant or breast-feeding,**ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/9/2025

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/9/2025

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 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/9/2025

Inactive ingredients

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 833-358-6431Monday 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

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride - FDA Drug Approval Details