Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Label at a glance#

Contacts and useful links#

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)	Purpose
Fexofenadine HCl, USP 60 mg	Antihistamine
Pseudoephedrine HCl, USP 120 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

• 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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• do not use if carton is opened or if individual blister units are torn or opened
• store between 68° to 77°F (20° to 25°C)
• USP dissolution test is pending.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 56062-999-30

NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ALLERGY & CONGESTION • INDOOR & OUTDOOR ALLERGIES

12-hour relief of:

• Nasal & sinus congestion due to colds or allergies
• Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies

ACTUAL SIZE

30
EXTENDED-RELEASE
TABLETS

*Compare to the active ingredients
in Allegra-D^®

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

• Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• PSEUDOEPHEDRINE HYDROCHLORIDE
• PSEUDOEPHEDRINE
• LACTOSE MONOHYDRATE
• MICROCRYSTALLINE CELLULOSE
• CROSCARMELLOSE SODIUM
• POVIDONE K30
• MAGNESIUM STEARATE
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• SILICON DIOXIDE
• ETHYLCELLULOSE, UNSPECIFIED
• FERRIC OXIDE YELLOW
• STEARIC ACID
• HYPROMELLOSE, UNSPECIFIED
• POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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