NASOPEN PE- phenylephrine hydrochloride, thonzylamine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), THONZYLAMINE HYDROCHLORIDE (UNII: 6K9YKD48Y4) (THONZYLAMINE - UNII:R79646H5Z8)

Available from:

GM Pharmaceuticals, INC

INN (International Name):

PHENYLEPHRINE HYDROCHLORIDE

Composition:

PHENYLEPHRINE HYDROCHLORIDE 10 mg in 15 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal Decongestant Antihistamine Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: - nasal congestion - reduces swelling of the nasal passages - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes

Authorization status:

OTC monograph final

Summary of Product characteristics

NASOPEN PE- PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE
LIQUID
GM PHARMACEUTICALS, INC
----------
NASOPEN PE
Nasopen PE
NDC 58809-729-04
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Supplied in a tight, light-resistant container with a child-resistant
cap.
DISTRIBUTED BY: GM Pharmaceuticals, Inc.
Arlington, TX 76015
DRUG FACTS
_ACTIVE INGREDIENTS (IN EACH 15 ML (TBSP))_
Phenylephrine HCl 10 mg
Thonzylamine HCl 50 mg
_PURPOSE_
Nasal Decongestant
Antihistamine
USES
Temporarily relieves these symptoms due to the common cold, hay fever
(allergic
rhinitis) or other upper respiratory allergies:
nasal congestion
reduces swelling of the nasal passages
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
WARNINGS
DO NOT EXCEED RECOMMENDED DOSAGE.
DO NOT USE THIS PRODUCT
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
difficulty in urination due to the enlargement of the prostate gland
glaucoma
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
excitability may occur, especially in children
may cause drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness
effect
use caution when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or accompanied by fever.
new symptoms occur
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