Drug facts

Aleve®- D Sinus & Cold Caplets
(NSAID Labeling)
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
*nonsteroidal anti-inflammatory drug
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
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 stomach problems, such as heartburn
● you have high blood pressure, heart disease, liver cirrhosis, or kidney
disease
● you are taking a diuretic
● you have problems or serious side effects from taking pain relievers or
fever reducers
● you have
● asthma ● diabetes ● thyroid disease
● trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
● under a doctor’s care for any serious condition
● taking any other drug
When using this product
● take with food or milk if stomach upset occurs
● the risk of heart attack or stroke may increase if you use more than
directed or for longer than directed
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Aleve®- D Sinus & Cold Caplets
(NSAID Labeling)
Stop use and ask a doctor if
● you experience any of the following signs of stomach bleeding:
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● redness or swelling is present in the painful area
● any new symptoms appear
● fever gets worse or lasts more than 3 days
● you have difficulty swallowing or the caplet feels stuck in your throat
● you get nervous, dizzy, or sleepless
● nasal congestion lasts more than 7 days
If pregnant or breast-feeding, ask a health professional before use. It is
especially important not to use naproxen sodium during the last 3 months of
pregnancy unless definitely directed to do so by a doctor because it may
cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away.
Directions
 do not take more than directed
 the smallest effective dose should be used
 swallow whole; do not crush or chew
 drink a full glass of water with each dose
 adults and children 12 years and older: 1 caplet every 12 hours; do not
take more than 2 caplets in 24 hours
 children under 12 years: do not use
Other information
● each caplet contains: sodium 20 mg
● store at 20-25oC (68-77oF)
 store in a dry place
Inactive ingredients colloidal silicon dioxide, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide Questions or comments? 1-800-986-0369 (Mon-Fri 9AM – 5PM
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Source: http://aleved.com/static/documents/Aleve-D-Sinus%26Cold-Caplets(NSAID).pdf