PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

AAA Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis - temporarily relieves sinus congestion and pressure

Authorization status:

OTC monograph final

Summary of Product characteristics

PSEUDOEPHEDRINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE TABLET,
COATED
AAA PHARMACEUTICAL, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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PSEUDOEPHEDRINE HCL TABLETS
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Pseudoephedrine HCl 30 mg
PURPOS E
Nasal decongestant
US ES
temporarily relieves nasal congestion due to the common cold, hay
fever or other upper respiratory
allergies, and nasal congestion associated with sinusitis
temporarily relieves sinus congestion and pressure
WARNINGS
DO NOT USE 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
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
WHEN USING THIS PRODUCT
DO NOT USE MORE THAN DIRECTED
STOP USE AND ASK A DOCTOR IF
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever
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
take 2 tablets every 4 to 6 hours
adults and children 12
years of age and over
take 2 tablets every 4 to 6 hours
do not take more than 8 tablets in 24 hours
children 6 to under 12
years of age
take 1 tablet every 4 to 6 hours
do not take more than 4 tablets in 24 hours
children under 6 years
of age
ask a doctor
OTHER INFORMATION
each tablet contains: CALCIUM 25 MG
store at 15°-25°C (59°-77°F) in a dry place
retain carton for complete product information
INACTIVE INGREDIENTS
colloidal silicon dioxi