Naproxen Sodium by Medline Industries / P and L Development of New York Corporation Naproxen Sodium
Naproxen Sodium by
Drug Labeling and Warnings
Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Medline Industries, P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NAPROXEN SODIUM- naproxen sodium tablet
Medline Industries
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Naproxen Sodium
Active ingredient (in each tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces 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
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
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
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
| Adults and children 12 years and older |
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| Children under 12 years |
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Other information
- each tablet contains: sodium 20 mg
- store at 20º to 25°C (68º to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
Inactive ingredients
croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide
Principal Display Panel
**Compare to the active ingredient in Aleve®
NAPROXEN
PAIN RELIEVER/
FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
Naproxen Sodium Tablets
220 mg
Tablets - 220 mg each
Distributed by:
Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT USE IF INNER SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Aleve®.
| NAPROXEN SODIUM
naproxen sodium tablet |
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| Labeler - Medline Industries (025460908) |
| Registrant - P & L Development, LLC (079765031) |