FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Pioneer Life Sciences, LLC

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FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

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

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have 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)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. You may report side effects to FDA at 1-800-FDA-1088.

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 right away.

Directions

 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; 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 printed foil inner seal on bottle is torn or missing  store between 20º and 25ºC (68º
and 77ºF)  protect from excessive moisture

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, povidone, pregelatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.

Questions or comments? call 1 (732) 689-5070

Manufactured for:

Pioneer Life Sciences, LLC

40E Suite A, Cotters Lane,East Brunswick, NJ 08816 USA

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India
Mfg. Lic. No.: G/1430

NDC 72090-010-99

Non-Drowsy
FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg
antihistamine

24 Hour

indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat

1000 tablets

image description

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-010-991000 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21013708/11/2023
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 8/2023
Document Id: b1a97357-d982-455c-a725-a15300bbc0f7
Set id: d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5
Version: 1
Effective Time: 20230810
 
Pioneer Life Sciences, LLC