PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hcl tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                PSEUDOEPHEDRINE HYDROCHLORIDE- PSEUDOEPHEDRINE HCL TABLET, FILM
COATED, EXTENDED RELEASE
PADAGIS ISRAEL PHARMACEUTICALS LTD
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PERRIGO PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Pseudoephedrine HCl 120 mg
PURPOSE
Nasal decongestant
USES
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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
•
•
•
•
•
WHEN USING THIS PRODUCT
DO NOT EXCEED RECOMMENDED DOSAGE
STOP USE AND ASK A DOCTOR IF
•
•
IF PREGNANT OR BREAST-FEEDING,
temporarily relieves nasal congestion due to the common cold, hay
fever or other
upper respiratory allergies
temporarily relieves sinus congestion and pressure
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
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
•
•
children under 12 years
do not use this product in children under 12 years of
age
OTHER INFORMATION
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INACTIVE INGREDIENTS
carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate
dihydrate,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
polysorbate 80, titanium dioxide
QUESTIONS OR COMMENTS?
1-800-719-9260
PRINCIPAL DISPLAY PANEL
Compare to Sudafed Sinus Congestion 12 Hour active ingredient
Pseudoephedrine Hydrochloride Extended Release Tablets 120 mg
Nasal Decongestant
Maximum Strength – Non-Drowsy
Sinus Pressure – Congestion
10 COATED 
                                
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