Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets Usp
bced0a2e-047e-456e-bbd2-495e83bf07ee
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each tablet) Fexofenadine Hydrochloride USP 180 mg Pseudoephedrine Hydrochloride USP 240 mg
Purpose
Antihistamine Nasal decongestant
Medication Information
Purpose
Antihistamine
Nasal decongestant
Description
Active ingredients (in each tablet) Fexofenadine Hydrochloride USP 180 mg Pseudoephedrine Hydrochloride USP 240 mg
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
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 24 hours on an empty stomach; do not take more than 1 tablet 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 between 20° and 25°C (68° and 77°F)
- FDA approved dissolution test specifications differ from USP
Drug Facts
Active ingredients (in each tablet)
Fexofenadine Hydrochloride USP 180 mg
Pseudoephedrine Hydrochloride USP 240 mg
Inactive Ingredients
cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, dibutyl sebacate, ferrosoferric oxide, glyceryl mono- and di-caprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide
Questions or Comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Manufactured for:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
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
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.
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.
Package Label Principal Display Panel 1 X 5 Blister Carton
AUROHEALTH
NDC 58602-844-60
*Compare to the active ingredients
in Allegra-D® 24 Hour
Allergy & Congestion Tablets
Non-Drowsy
Allergy & Congestion
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets USP 180 mg/240 mg
Fexofenadine Hydrochloride 180 mg/antihistamine
Pseudoephedrine Hydrochloride 240 mg/nasal decongestion
24 HR
Indoor / Outdoor Relief Of
- Nasal and Sinus Congestion Due to Colds or Allergens
- Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies
Actual size
5 Extended-Release Tablets
Structured Label Content
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
Purpose
Antihistamine
Nasal decongestant
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
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 24 hours on an empty stomach; do not take more than 1 tablet 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 between 20° and 25°C (68° and 77°F)
- FDA approved dissolution test specifications differ from USP
Drug Facts
Active ingredients (in each tablet)
Fexofenadine Hydrochloride USP 180 mg
Pseudoephedrine Hydrochloride USP 240 mg
Inactive Ingredients (Inactive ingredients)
cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, dibutyl sebacate, ferrosoferric oxide, glyceryl mono- and di-caprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide
Questions or Comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Manufactured for:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
When Using This Product (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 (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
If pregnant or breast-feeding, ask a health professional before use.
Keep Out of Reach of Children. (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.
Ask A Doctor Before Use If You Have (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.
Package Label Principal Display Panel 1 X 5 Blister Carton (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton)
AUROHEALTH
NDC 58602-844-60
*Compare to the active ingredients
in Allegra-D® 24 Hour
Allergy & Congestion Tablets
Non-Drowsy
Allergy & Congestion
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets USP 180 mg/240 mg
Fexofenadine Hydrochloride 180 mg/antihistamine
Pseudoephedrine Hydrochloride 240 mg/nasal decongestion
24 HR
Indoor / Outdoor Relief Of
- Nasal and Sinus Congestion Due to Colds or Allergens
- Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies
Actual size
5 Extended-Release Tablets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:58.720620 · Updated: 2026-03-14T23:08:25.015175