Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Labeler
- Strategic Sourcing Services LLC
- Label updated
- 2025-05-09
- Retrieved
- 2026-09-07
- Active ingredients
- FEXOFENADINE HYDROCHLORIDE · 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
Label information
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: af4604bd-6a9f-4af6-aefb-479e85b5b8e2 · Version 1
NDC: 70677-1278