SUDAFED 12 HOUR PRESSURE AND PAIN naproxen sodium pseudoephedrine hydrochloride tablet film coated extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naproxen sodium (UNII: 9TN87S3A3C) (Naproxen - UNII:57Y76R9ATQ)

Available from:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

INN (International Name):

Naproxen sodium

Composition:

Naproxen sodium 220 mg

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUDAFED 12 HOUR PRESSURE AND PAIN- NAPROXEN SODIUM AND PSEUDOEPHEDRINE
HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION
----------
SUDAFED
12 HOUR PRESSURE+PAIN
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
_PURPOSES_
*
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
Pain reliever/fever reducer
Pseudoephedrine HCl 120 mg, extended-release
Nasal decongestant
US ES
temporarily relieves these cold, sinus, and flu symptoms:
sinus pressure
minor body aches and pains
headache
nasal and sinus congestion (promotes sinus drainage and restores freer
breathing through the nose)
fever
WARNINGS
ALLERGY ALERT
Naproxen sodium may cause a severe allergic reaction, especially in
people allergic to aspirin.
Symptoms may include:
hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters
If an allergic reaction occurs, stop use and seek medical help right
away.
STOMACH BLEEDING WARNING
This product contains an NSAID, which may cause severe stomach
bleeding. The chance is higher if
you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen,
or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
®
nonsteroidal anti-inflammatory drug
*
DO NOT USE
if you have ever had an allergic reaction to any other pain
reliever/fever reducer
right before or after heart surgery
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.
in children under 12 years of age
ASK A DOCTOR BEFORE USE IF
the stomach bleeding warning applies to you
you have a history of stoma