CLARITIN-D 12 HOUR- loratadine and pseudoephedrine sulfate 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:

Bayer HealthCare LLC.

INN (International Name):

LORATADINE

Composition:

LORATADINE 5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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 - 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

Authorization status:

New Drug Application

Summary of Product characteristics

CLARITIN-D 12 HOUR- LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET,
EXTENDED RELEASE
BAYER HEALTHCARE LLC.
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CLARITIN-D
12 HOUR
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
_PURPOSE_
Loratadine 5 mg
Antihistamine
Pseudoephedrine sulfate 120 mg
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
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
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.
DIRECTIONS
do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over
1 tablet every 12 hours; not more than 2 tablets
in 24 hours
children under 12 years