FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and pseudoephedrine hci tablet, extended release
Dr. Reddy's Laboratories Limited

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Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpose

Antihistamine

Nasal decongestant

Use(s)

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 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 takeas 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

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

Storage

Inactive ingredients

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel

Blister carton 20's (4x5 unit-dose)

carton

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
fexofenadine hcl and pseudoephedrine hci tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-447
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
Product Characteristics
Color WHITE (off white to pale yellow one layer and light red to red other layer) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code R;195
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55111-447-35 2 in 1 CARTON
1 NDC:55111-447-07 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:55111-447-14 4 in 1 CARTON
2 NDC:55111-447-07 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:55111-447-31 6 in 1 CARTON
3 NDC:55111-447-07 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076667 11/18/2014
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 11/2013
Document Id: e0a7f340-e70c-17b7-0586-9a4dffe078bd
Set id: 728632be-7e5c-2d06-4c95-bc8ecc9be2ec
Version: 5
Effective Time: 20131126
Dr. Reddy's Laboratories Limited