Allegra-D 24 Hour Allergy and Congestion description, usages, side effects, indications, overdosage, supplying and lots more!

Allegra-D 24 Hour Allergy and Congestion

Chattem, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Allegra-D 24 Hour Allergy and Congestion



FULL PRESCRIBING INFORMATION

Drug Facts

( in each tablet)

Fexofenadine HCI 180 mg

Antihistamine

( in each tablet)

Pseudoephedrine HCI 240 mg

Nasal decongestant

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ▪ runny nose
    ▪ sneezing
    ▪ nasal congestion
    ▪ itchy, watery eyes
    ▪ itching of the nose or throat
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose
  • 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
  • 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.
  • 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).
  • 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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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
  • each tablet contains: sodium 33 mg
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)

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, methyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water

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

NDC 41167-4320-3
NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH
Allegra-D®
Allergy & Congestion
fexofenadine HCI 180 mg/antihistamine
pseudoephedrine HCI 240 mg/nasal decongestant
Extended Release Tablets
5 Tablets

NDC 41167-4320-5
NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH
Allegra-D®
Allergy & Congestion
fexofenadine HCI 180 mg/antihistamine
pseudoephedrine HCI 240 mg/nasal decongestant
Extended Release Tablets
10 Tablets

NDC 41167-4320-7
NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH
Allegra-D®
Allergy & Congestion
fexofenadine HCI 180 mg/antihistamine
pseudoephedrine HCI 240 mg/nasal decongestant
Extended Release Tablets
15 Tablets

Allegra-D®
Allergy & Congestion
fexofenadine HCI 180 mg/antihistamine
pseudoephedrine HCI 240 mg/nasal decongestant
24 Hour
Extended Release Tablets
5ct Blister Pack

Allegra-D 24 Hour Allergy and Congestion

fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41167-4320
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 240 mg

Inactive Ingredients

Ingredient Name Strength
ALUMINUM OXIDE
triacetin
acetone
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
SILICON DIOXIDE
COPOVIDONE K25-31
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSES
ISOPROPYL ALCOHOL
MAGNESIUM STEARATE
METHYL ALCOHOL
methylene chloride
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
propylene glycol
POVIDONES
SODIUM CHLORIDE
talc
titanium dioxide
water

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm 308;AV ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 5 in 1 BLISTER PACK
3 5 in 1 BLISTER PACK
4 NDC:41167-4320-7 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021704 2011-03-03


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