Label: NAPROXEN- naproxen sodium tablet, film coated
- NDC Code(s): 50844-271-43
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 12, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- shock
- skin reddening
- hives
- rash
- blisters
- facial swelling
- asthma (wheezing)
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 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
Ask a doctor before use if
- 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 or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
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:
- leg swelling
- chest pain
- slurred speech
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for 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
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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 over:
■ Take 1 tablet every 8 to 12 hours while symptoms persist.
■ For the first dose you may take 2 tablets within the first hour.
■ Do not exceed 2 tablets in any 8 to 12 hour period.
■ Do not exceed 3 tablets in a 24 hour period.
Children under 12 years:
Ask a doctor. - Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
QUALITY
+ PLUSNDC 50844-271-43
†Compare to active ingredient
in Aleve® TabletsNAPROXEN
NAPROXEN SODIUM USP, 220 mgPAIN RELIEVER/
FEVER REDUCER (NSAID)60 Packets
of 1 Tablet each
220 mg eachACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF PACKET
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING†This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered
trademark Aleve® Tablets.
50844 ORG
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-746
-
INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-271 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code I3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-271-43 60 in 1 CARTON 09/12/2019 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079096 09/12/2019 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(50844-271)