PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Publix Super Markets 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 - temporarily relieves sinus congestion and pressure

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PSEUDOEPHEDRINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE TABLET,
FILM
COATED, EXTENDED RELEASE
PUBLIX SUPER MARKETS INC
----------
PSEUDOEPHEDRINE HYDROCHLORIDE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Pseudoephedrine HCl, USP 120 mg
PURPOS E
Nasal decongestant
US ES
temporarily relieves nasal congestion due to the common cold, hay
fever or other upper respiratory
allergies
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 EXCEED RECOMMENDED DOSAGE
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a 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. (1-800-222-1222)
DIRECTIONS
adults and children
12 years and over
take 1 tablet every 12 hours
do not take more than 2 tablets in 24
hours
children under 12
years
do not use this product in children under
12 years of age
OTHER INFORMATION
store at 59° to 77° F in a dry place. Protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR
SHOW ANY SIGNS OF TAMPERING.
INACTIVE INGREDIENTS
castor oil, colloidal silicon dioxide, hypromellose, microcrystalline
cellulose, magnesium stearate,
titanium dioxide
QUES TIONS ?
call 1-800-406-7984
DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY, LAKELAND,
FL
33811
PRINCIPAL DISPLAY PANEL - 120 MG TABLET BLISTER PACK CARTON
NDC 56062-204-21
NON