NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND COLD- naproxen sodium and pseudoephedrine hydrochloride tablet, exte

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Aurohealth LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Nasal decongestant 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 - 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 - the stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND
COLD - NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
AUROHEALTH LLC
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NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, USP 220 MG/120 MG SINUS AND COLD
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine Hydrochloride USP 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
_PURPOSES_
Pain reliever/fever reducer
Nasal decongestant
_USES_
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
HEART ATTACK AND STROKE WARNING: NSAIDs, except aspirin, increase the
risk of heart
attack, heart failure, and stroke. These can be fatal. The risk is
higher if you use more
than directed or for longer than directed.
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 a