Label: NAPROXEN- naproxen sodium tablet, film coated
- NDC Code(s): 46122-564-71, 46122-564-78, 46122-564-81
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 9, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
-
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- skin reddening
- shock
- blisters
- rash
- facial swelling
- hives
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]
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
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
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- 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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- 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 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
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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 older
- take 1 caplet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 caplets within the first hour
- do not exceed 2 caplets in any 8- to 12-hour period
- do not exceed 3 caplets in a 24-hour period
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
GOOD
NEIGHBOR
PHARMACY®Compare to ALEVE® active ingredient†
NDC 46122-564-71
Naproxen
naproxen sodium tablets 220 mg (NSAID)Pain Reliever/Fever Reducer
Strength to last 12 hours
50 Caplets
220 mg EachActual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by Bayer HealthCare
LLC, owner of the registered trademark Aleve®.
50844 REV1221B60415Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.comGOOD NEIGHBOR PHARMACY
SATISFACTION
GUARANTEED
BRAND PRODUCTS
GNP 44-604
-
INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-564 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--ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 44;604 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-564-78 1 in 1 CARTON 02/01/2019 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:46122-564-81 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2019 3 NDC:46122-564-71 1 in 1 CARTON 02/01/2019 3 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 02/01/2019 Labeler - Amerisource Bergen (007914906) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(46122-564) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(46122-564) , pack(46122-564) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(46122-564) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(46122-564) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(46122-564)