fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets usp

fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets usp
SPL v8
SPL
SPL Set ID 1fcb601c-19d2-4db9-938b-b4f98ba9332f
Route
oral
Published
Effective Date 2024-06-26
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
fexofenadine (60 mg) pseudoephedrine (120 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium ferric oxide yellow hypromellose 2208 (100000 mpa.s) microcrystalline cellulose lactose monohydrate hydroxypropyl cellulose (110000 wamw) polyethylene glycol 6000 polyethylene glycol 400 starch, corn stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: Z;79 Shape: capsule Color: yellow Size: 19 mm Score: 1
Marketing Status
anda active Since 2017-10-30

Purpose

Antihistamine Nasal decongestant

Description

Active ingredients (in each tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg


Medication Information

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
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
Purpose

Antihistamine

Nasal decongestant

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 tablets 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 carton is opened or if individual blister units are torn or opened. 
  • store at 20-25°C (68-77°F).
  • Meets USP dissolution test 7
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid



Questions or Comments?



call 1-855-274-4122



IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.



DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

©2021 Walgreen Co.

MADE IN INDIA


Code: TS/DRUGS/22/2009

Description

Active ingredients (in each tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg

Drug Facts

Active ingredients (in each tablet)



Fexofenadine HCl USP 60 mg

Pseudoephedrine HCl USP 120 mg

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 (1-800-222-1222) 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.
Package Label Principal Display Panel  2 X 10 Blister Carton

Walgreens



Compare to the active ingredients in

Allegra-D® 12 Hour

Allergy & Congestion Tablets††



NDC 0363-0094-67



NON-DROWSY

Allergy Relief D12

ALLERGY & CONGESTION



Fexofenadine HCl USP 60 mg / Antihistamine

Pseudoephedrine HCl USP 120 mg / Nasal decongestant



12 Hour

Extended-Release Tablets USP



Indoor & Outdoor Allergies

  • Nasal and sinus congestion d ue to colds or allergies
  • Relief of sneezing; runny nose; itchy, watery eyes

    and itchy nose or throat due to allergies    



20 EXTENDED-RELEASE TABLETS














Structured Label Content

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
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
Purpose

Antihistamine

Nasal decongestant

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 tablets 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 carton is opened or if individual blister units are torn or opened. 
  • store at 20-25°C (68-77°F).
  • Meets USP dissolution test 7
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid



Questions or Comments?



call 1-855-274-4122



IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.



DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

©2021 Walgreen Co.

MADE IN INDIA


Code: TS/DRUGS/22/2009

Drug Facts

Active ingredients (in each tablet)



Fexofenadine HCl USP 60 mg

Pseudoephedrine HCl USP 120 mg

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, 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 (1-800-222-1222) 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.
Package Label Principal Display Panel  2 X 10 Blister Carton (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton)

Walgreens



Compare to the active ingredients in

Allegra-D® 12 Hour

Allergy & Congestion Tablets††



NDC 0363-0094-67



NON-DROWSY

Allergy Relief D12

ALLERGY & CONGESTION



Fexofenadine HCl USP 60 mg / Antihistamine

Pseudoephedrine HCl USP 120 mg / Nasal decongestant



12 Hour

Extended-Release Tablets USP



Indoor & Outdoor Allergies

  • Nasal and sinus congestion d ue to colds or allergies
  • Relief of sneezing; runny nose; itchy, watery eyes

    and itchy nose or throat due to allergies    



20 EXTENDED-RELEASE TABLETS














Advanced Ingredient Data


Raw Label Data

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