Aleve-D Sinus and Headache (naproxen sodium 220 mg pseudoephedrine hydrochloride 120 mg) Dailymed
Generic: naproxen sodium, pseudoephedrine hydrochloride is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Back Pain Bursitis Common Cold Dysmenorrhea Fever Gout Headache Inflammation Osteoarthritis Pain Pregnancy Trimester, Third Spondylitis, Ankylosing Toothache Asthma Rhinitis, Allergic, Perennial Sinusitis
IMPRINT: ALEVE D
SHAPE: oval
COLOR: white
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Drug Facts
Otc - Active Ingredient Section
Active ingredients
(in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg,
*nonsteroidal anti-inflammatory drug
Otc - Purpose Section
Purposes
Pain reliever/fever reducer
Nasal decongestant
Indications & Usage Section
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 Section
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 • bulers
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.
Otc - Do Not Use Section
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
Otc - Ask Doctor Section
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,asthma • thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland or had a stroke
• you are taking a diuretic
• you have problems or serious side effects from taking pain
relievers or fever reducers
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking any other drug
Otc - When Using Section
When using this product
• take with food or milk if stomach upset occurs
Otc - Stop Use Section
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
●you have symptoms of heart problems or stroke:
● chest pain
● trouble breathing
● weakness in one part or side of body
● slurred speech
● leg swelling
● 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
Otc - Pregnancy Or Breast Feeding Section
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.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Dosage & Administration Section
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
Other information
• each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • store in a dry place
Inactive Ingredient Section
Inactive ingredients colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, talc, titanium dioxide
Otc - Questions Section
Questions or comments?
1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
Package Label.principal Display Panel
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NON-DROWSY
ALL DAY STRONG®
ALEVE-D®
SINUS & HEADACHE
Naproxen sodium 220 mg (NSAID)
Pseudoephedrine HCl 120 mg extended-release tablets
Pain reliever-fever reducer/nasal decongestant
12 HOUR MULTI-SYMPTOM RELIEF OF
SINUS PRESSURE
HEADACE · SINUS CONGESTION
NASAL CONGESTION
actual size
1 CAPLET - 12 HOURS
10 CAPLETS
CAPSULE-SHAPED TABLETS
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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