Fexofenadine HCl and Pseudoephedrine HCI description, usages, side effects, indications, overdosage, supplying and lots more!

Fexofenadine HCl and Pseudoephedrine HCI

Dr.Reddy's Laboratories Limited

  • 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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 mg

Purpose

Antihistamine

Nasal decongestant

Use(s)

  • 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

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

Ask a doctor before use if

  • 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 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

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contacta Poison Control Center 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 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

Other information

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened

Storage

store between 20° - 25°C (68° - 77°F)

Inactive ingredients

acetyltributyl citrate, colloidal silicon dioxide, copovidone, croscarmellose sodium, ethylcellulose, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.

Questions or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Blister carton label : 10's

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Fexofenadine HCl and Pseudoephedrine HCI

Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-557
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
ACETYLTRIBUTYL CITRATE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSES
COPOVIDONE
HYPROMELLOSES
cellulose, microcrystalline
polyethylene glycol
SODIUM STEARYL FUMARATE
talc
titanium dioxide
COLLOIDAL SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL

Product Characteristics

Color Size Imprint Code Shape
WHITE 21 mm RDY;572 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 5 in 1 BLISTER PACK
3 NDC:55111-557-35 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079043 2011-08-24


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Be sure to consult your doctor before taking any medication!
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