TOPCARE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine sulfate tablet, film coated, 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:

Topco Associates LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine Nasal decongestant

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOPCARE ALLERGY AND CONGESTION RELIEF- LORATADINE, PSEUDOEPHEDRINE
SULFATE TABLET, FILM COATED, EXTENDED RELEASE
TOPCO ASSOCIATES LLC
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TOPCO ASSOCIATES LLC. ALLERGY & CONGESTION RELIEF DRUG FACTS
ACTIVE INGREDIENTS (IN EACH TABLET)
Loratadine 5 mg
Pseudoephedrine sulfate 120 mg
PURPOSE
Antihistamine
Nasal decongestant
USES
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WARNINGS
DO NOT USE
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ASK A DOCTOR BEFORE USE IF YOU HAVE
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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
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.
heart disease
thyroid disease
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WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED.
Taking more than directed may cause drowsiness.
STOP USE AND ASK A DOCTOR IF
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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
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adults and children 12 years and over
1 tablet every 12 hours; not more than 2
tablets in 24 hours
children under 12 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
OTHER INFORMATION
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INACTIVE INGREDIENTS
croscarmellose sodium, dibasic calcium phosphate, hypromellose,
lactose monohydrate,
magnesium stearate, pharmaceutical in