SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

INN (International Name):

Phenylephrine Hydrochloride

Composition:

Phenylephrine Hydrochloride 10 mg

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant - temporarily relieves sinus congestion and pressure - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat - nasal congestion - temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion - runny nose - sneezing - nasal congestion - temporarily relieves sinus congestion and pressure

Authorization status:

OTC monograph final

Summary of Product characteristics

SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION- DIPHENHYDRAMINE
HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
SUDAFED PE DAY + NIGHT SINUS CONGESTION
SUDAFED PE DAYTIME
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Phenylephrine HCl 10 mg
PURPOSE
Nasal decongestant
USES
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay
fever or other
upper respiratory allergies
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 DOSE
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 4 hours
do not take more than 6
tablets in 24 hours
children under 12
years
ask a doctor
OTHER INFORMATION
store between 20-25°C (68-77°F)
DO NOT USE IF CARTON OR BLISTER UNIT IS OPENED OR BROKEN
INACTIVE INGREDIENTS
carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40
aluminum lake, FD&C
yellow no. 6 aluminum lake, magnesium stearate, microcrystalline