PSEUDOEPHEDRINE HYDROCHLORIDE- 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:

HEB

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies - temporarily restores freer breathing through the nose - promotes nasal and/or sinus drainage - 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
HEB
----------
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:
common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
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
diabetes
thyroid disease
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
symptoms do not get better within 7 days or occur with a fever
you get nervous, dizzy, or sleepless
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 older: 1 tablet every 12 hours; not
more than 2 tablets in 24 hours
children under 12 years: ask a doctor
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
PRINCIPAL DISPLAY PANEL - 120 MG TABLET BLISTER PACK CARTON
_**COMPARE TO SUDAFED 12 HOUR_ active ingredient
NDC 37808-204-21
H-E-B
Maximum Strength
12 HOUR DECONGESTANT
Pseudoephed