ALLEGRA-D ALLERGY AND CONGESTION- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Chattem, Inc.

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Allegra-D Allergy and Congestion 24 HR

Drug Facts

Active ingredients

(in each extended-release tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Active ingredients

(in each extended-release tablet) 

Pseudoephedrine HCl 240 mg

Purpose

Nasal decongestant

Uses

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

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 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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

Inactive ingredients

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, glycerol triacetate, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water

Questions or comments?

call toll-free 1-800-633-1610 or www.allegra.com

PRINCIPAL DISPLAY PANEL

NDC 41167-4320-7
NON-DROWSY
Allegra-D®
ALLERGY & CONGESTION
fexofenadine HCl 180 mg/antihistamine
pseudoephedrine HCl 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

PRINCIPAL DISPLAY PANEL
NDC 41167-4320-7
NON-DROWSY
Allegra-D®
ALLERGY & CONGESTION
fexofenadine HCl 180 mg/antihistamine
pseudoephedrine HCl 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

ALLEGRA-D ALLERGY AND CONGESTION 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE240 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIACETIN (UNII: XHX3C3X673)  
ACETONE (UNII: 1364PS73AF)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize19mm
FlavorImprint Code 308;AV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4320-31 in 1 CARTON03/03/201103/01/2019
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-4320-52 in 1 CARTON03/03/2011
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-4320-73 in 1 CARTON03/03/2011
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02170403/03/2011
Labeler - Chattem, Inc. (003336013)

Revised: 12/2020
Document Id: f7a5258f-2add-41a4-90d8-386bf49039b2
Set id: 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403
Version: 32
Effective Time: 20201203
 
Chattem, Inc.