FDA Label for Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

Purpose

Antihistamine
Nasal decongestant

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

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

• 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

• 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

• 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

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

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.

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 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 833-358-6431 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

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 Carton - fexofenadine fig1