Allegra-d Allergy And Congestion 12 Hr

Allegra-d Allergy And Congestion 12 Hr
SPL v36
SPL
SPL Set ID b32e172a-abf5-4c17-aa39-19e517952b91
Route
ORAL
Published
Effective Date 2021-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 06;012D Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
NDA Active Since 2011-03-03

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 12 hours on an empty stomach; do

not take more than 2 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
  • 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 tablet)

Fexofenadine HCl 60 mg

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid

Questions Or Comments?

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

Principal Display Panel

NDC 41167-4310-6

Allegra-D®

Allergy &

Congestion 12HR

fexofenadine HCl 60 mg/antihistamine

pseudoephedrine HCl 120 mg/nasal decongestant

Extended Release Tablets

30 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 12 hours on an empty stomach; do

not take more than 2 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)
  • 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 tablet)

Fexofenadine HCl 60 mg

Inactive Ingredients (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 41167-4310-6

Allegra-D®

Allergy &

Congestion 12HR

fexofenadine HCl 60 mg/antihistamine

pseudoephedrine HCl 120 mg/nasal decongestant

Extended Release Tablets

30 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

All Sections (JSON)