Allegra-d Allergy And Congestion 24 Hr

Allegra-d Allergy And Congestion 24 Hr
SPL v32
SPL
SPL Set ID 1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403
Route
ORAL
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg) Pseudoephedrine (240 mg)
Inactive Ingredients
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 Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Propylene Glycol Povidone Sodium Chloride Talc Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: 308;AV Shape: round Color: white Size: 19 mm Score: 1
Marketing Status
NDA Completed Since 2011-03-03 Until 2019-03-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

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
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
Other Information
  • 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)
Active Ingredients

(in each extended-release tablet)

Fexofenadine HCl 180 mg

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

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.

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.

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Antihistamine

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
Do Not Use (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
Other Information (Other information)
  • 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)
Active Ingredients (Active ingredients)

(in each extended-release tablet)

Fexofenadine HCl 180 mg

Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel (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

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, (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 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.

Advanced Ingredient Data


Raw Label Data

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