Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP
af4604bd-6a9f-4af6-aefb-479e85b5b8e2
HUMAN OTC DRUG LABEL
May 9, 2025
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
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
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
Drug Facts
Active ingredients (in each tablet)
Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
Nasal decongestant
WARNINGS SECTION
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
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
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
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
**If pregnant or breast-feeding,**ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
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
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