FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI tablet, extended release

Fexofenadine HCl and Pseudoephedrine HCI by

Drug Labeling and Warnings

Fexofenadine HCl and Pseudoephedrine HCI by is a Otc medication manufactured, distributed, or labeled by HEB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 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 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

• 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
• this product meets the requirements of USP dissolution test 3.

Storage

• store between 20° to 25°C (68° to 77°F)

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 30's (6x5 unit-dose)

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
fexofenadine hcl and pseudoephedrine hci tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-022(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: 37808-022-31	6 in 1 CARTON	12/21/2015
1		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	12/21/2015

Labeler - HEB (007924756)