Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release
- NDC Code(s): 58602-844-60, 58602-844-66, 58602-844-85
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 18, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
-
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
-
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
- Keep out of reach of children.
-
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
-
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 -
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 TabletsNon-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
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-844 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE K25-31 (UNII: D9C330MD8B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBUTYL SEBACATE (UNII: 4W5IH7FLNY) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE 200 (UNII: 5XDI2TS1EZ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (biconvex with slightly blister surfaced) Size 13mm Flavor Imprint Code FES Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-844-60 1 in 1 CARTON 04/17/2025 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:58602-844-66 2 in 1 CARTON 04/17/2025 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:58602-844-85 3 in 1 CARTON 04/17/2025 3 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215232 04/17/2025 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-844) , MANUFACTURE(58602-844)