Label: NAPROXEN HEADACHE PAIN- naproxen sodium tablet, film coated
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NDC Code(s):
50844-471-11,
50844-471-14,
50844-471-16,
50844-471-19, view more50844-471-22, 50844-471-43, 50844-471-56, 50844-471-98, 50844-471-99
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- shock
- rash
- blisters
- skin reddening
- 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
- have had stomach ulcers or bleeding problems
- are age 60 or older
- take a blood thinning (anticoagulant) or steroid drug
- take more or for a longer time than directed
- 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
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 are taking a diuretic
- 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 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:
- weakness in one part or side of body
- leg swelling
- chest pain
- slurred speech
- trouble breathing
- pain gets worse or lasts more than 10 days
- you have difficulty swallowing
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- it feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
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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 tablet every 8 to 12 hours while symptoms last
- 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?
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Principal display panel
QUALITY
+PLUSNDC 50844-471-16
†Compare to
active ingredient in
Aleve® Headache Pain
TabletsNAPROXEN
HEADACHE PAINNAPROXEN SODIUM
TABLETS, 220 mgPAIN RELIEVER/FEVER
REDUCER (NSAID)For temporary relief of minor headache pain
STRENGTH TO LAST
12 HOURS1000
Coated TabletsACTUAL 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®
Headache Pain Tablets. 50844 REV1221A41716Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USAQuality Plus 44-417 HP
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INGREDIENTS AND APPEARANCE
NAPROXEN HEADACHE PAIN
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-471 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 ROUND Size 10mm Flavor Imprint Code 44;417 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-471-22 48 in 1 CARTON 09/16/2020 1 NDC:50844-471-43 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:50844-471-11 60 in 1 CARTON 09/16/2020 2 NDC:50844-471-43 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:50844-471-99 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2020 4 NDC:50844-471-98 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2020 5 NDC:50844-471-19 1 in 1 CARTON 09/16/2020 5 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:50844-471-56 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2020 7 NDC:50844-471-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2020 8 NDC:50844-471-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 09/16/2020 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(50844-471) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(50844-471) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50844-471) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(50844-471) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(50844-471)