Fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

Drug facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

Purpose

Antihistamine
Nasal decongestant

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

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 Parkinsons 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 (1-800-222-1222) right away.

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 20-25C (68-77F).
  • USP Dissolution Test Pending.

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 McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
healthmart.com

Made in India
Code: TS/DRUGS/22/2009

Ingredients and appearance - Product information

Fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release- Fexofenadine hydrochloride and pseudoephedrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 62011-0376
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 60 mgin 1
Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Ferric oxide yellow ( UNII: EX438O2MRT)
Hypromellose 2208 (100000 mpa.s) ( UNII: VM7F0B23ZI)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hydroxypropyl cellulose (110000 wamw) ( UNII: 5Y0974F5PW)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)

Product Characteristics

Color YELLOW (White to Off White Layer and Yellow to Pale Yellow) Shape CAPSULE (Bincovex)
Size 19 mm Score 1
Imprint Code Z;79

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209116 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Establishment

Name ID/FEI Business Operations
Strategic Sourcing Services LLC 116956644 ANALYSIS( 62011-0376), MANUFACTURE( 62011-0376)

Package label-principal display panel -2 x 10 blister carton


NDC 62011-0376-1

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Health Mart ®
Allergy & Congestion

Fexofenadine HCl andPseudoephedrine HCl
Extended-Release Tablets USP 60 mg / 120 mg

Fexofenadine HCl 60 mg / antihistamine
Pseudoephedrine HCl 120 mg / nasal decongestion


indoor / outdoor relief of

  • nasal andsinus congestion due to colds or allergies
  • sneezing; runny nose; itchy, watery eyes and itchy nose or throat due to allergies


20 extended release tablets