TOPCARE SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl 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), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Topco Associates LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Nasal decongestant temporarily relieves these cold, sinus, and flu symptoms:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOPCARE SINUS AND COLD D- NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL TABLET,
FILM COATED, EXTENDED RELEASE
TOPCO ASSOCIATES LLC
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TOPCO ASSOCIATES LLC. SINUS & COLD-D DRUG FACTS
ACTIVE INGREDIENTS (IN EACH CAPLET)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
PURPOSES
Pain reliever/fever reducer
Nasal decongestant
USES
temporarily relieves these cold, sinus, and flu symptoms:
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WARNINGS
ALLERGY ALERT: Naproxen sodium may cause a severe allergic reaction,
especially in
people allergic to aspirin. Symptoms may include:
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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:
sinus pressure
minor body aches and pains
headache
nasal and sinus congestion (promotes sinus drainage and restores freer
breathing
through the nose)
fever
hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters
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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
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ASK A DOCTOR BEFORE USE IF
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
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WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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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
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 o