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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Target Brands Inc.

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine Nasal decongestant - 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- FEXOFENADINE HCL AND
PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE
TARGET BRANDS INC.
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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
PURPOS E
Antihistamine
Nasal decongestant
US E(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/BREAS TFEEDING
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, che