ALAVERT ALLERGY SINUS D-12- 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:

Haleon US Holdings LLC

INN (International Name):

loratadine

Composition:

loratadine 5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine Nasal decongestant

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALAVERT ALLERGY SINUS D-12- LORATADINE, PSEUDOEPHEDRINE SULFATE
TABLET,
FILM COATED, EXTENDED RELEASE
HALEON US HOLDINGS LLC
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_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH TABLET)_
Loratadine 5 mg
Pseudoephedrine sulfate 120 mg
_PURPOSES_
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:
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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
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
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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_
•
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 ink, povidone, titanium dioxide
_QUESTIONS OR COMMENTS?_
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