PSEUDOEPHEDRINE HCL tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
03-11-2022

Aktiv ingrediens:

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

Tilgjengelig fra:

Aurohealth LLC

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE

Sammensetning:

PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves sinus congestion and pressure 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 - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland -  nervousness, dizziness, or sleeplessness occur - symptoms do not improve within 7 days or occur with a fever

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                PSEUDOEPHEDRINE HCL - PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE
AUROHEALTH LLC
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PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABLETS USP 120 MG
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Pseudoephedrine HCl USP 120 mg
_PURPOSE_
Nasal decongestant
_USES_
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_
EACH TABLET CONTAINS: calcium 36 mg
store at 20° to 25°C (68° to 77°F). Protect from light.
do not use if the individual blister unit is open or torn
see side panel for lot number and expiration date
Meets USP dissolution test 4
_INACTIVE INGREDIENTS_
colloidal silicon dioxide, dibasic calcium phosphate dihydrate,
hydroxypropyl cellulose,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, talc,
and titanium dioxide.
_QUESTIONS OR COMMENTS?_
call 1-855-274-4122

                                
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