LORATADINE AND PSEUDOEPHEDRINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN), PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

REMEDYREPACK INC.

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: sneezing itchy, watery eyes runny nose itching of the nose or throat - sneezing - itchy, watery eyes - runny nose - itching of the nose or throat - reduces swelling of nasal passages - temporarily relieves sinus congestion and pressure - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily restores freer breathing through the nose

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LORATADINE AND PSEUDOEPHEDRINE- LORATADINE AND
PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE
REMEDYREPACK INC.
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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH TABLET)
Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg
PURPOSE
Antihistamine
Nasal decongestant
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
sneezing
itchy, watery eyes
runny nose
itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay
fever or other
upper respiratory allergies
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.
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a
different dose.
WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED.
Taking more than directed may cause drowsiness.
STOP USE AND ASK A 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.
nervousness, dizziness or sleeplessness occurs
IF PREGNANT OR BREAST-FEEDING
Ask a health professional before use.
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
do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over
1 tablet daily with a full glass of water;
not more than 1 tablet in 24 hours
chil