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![NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]](https://medic.hrt.org//dailymed/images/717518e4-2537-4229-b765-c6acfe963d4b/quality-plus-44-417-and-44-604-2.jpg)
| NDC | 50844-417-14, 50844-417-16, 50844-417-19, 50844-417-56, 50844-417-98, 50844-417-99, 50844-604-09, 50844-604-14, 50844-604-16, 50844-604-19, 50844-604-56, 50844-604-98, 50844-604-99 |
| Set ID | 717518e4-2537-4229-b765-c6acfe963d4b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L.N.K. International, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA204872 |
- 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:
- 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:
- 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
- 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
-
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?
- 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:
- slurred speech
- trouble breathing
- leg swelling
- weakness in one part or side of body
- chest pain
- 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
- 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
QUALITY
+PLUSNDC 50844-417-16
†Compare to
active ingredient
in Aleve® TabletsNAPROXEN
SODIUM
TABLETS, 220 mgPAIN RELIEVER/
FEVER REDUCER (NSAID)STRENGTH TO LAST
12 HOURS1000
Coated TabletsACTUAL
SIZETAMPER 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® Tablets.
50844 REV0520B41716Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
Quality Plus 44-417
-
Principal display panel
QUALITY
+PLUSNDC 50844-604-09
†Compare to the active ingredient
in Menstridol ®NAPROXEN SODIUM
TABLETS, 220 mgPAIN RELIEVER/FEVER REDUCER (NSAID)
UP TO 12 HOURS OF MENSTRUAL PAIN RELIEF
Temporarily relieves minor cramps, backache, headache
20 Coated Caplets**
**CAPSULE-SHAPED TABLETSACTUAL
SIZETAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT 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 Menstridol®. 50844 REV0520B60409Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-604
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-417 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:50844-417-99 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 2 NDC:50844-417-98 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 3 NDC:50844-417-19 1 in 1 CARTON 02/01/2017 3 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:50844-417-56 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 5 NDC:50844-417-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 6 NDC:50844-417-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 02/01/2017 NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-604 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:50844-604-99 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 2 NDC:50844-604-98 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 3 NDC:50844-604-19 1 in 1 CARTON 02/01/2017 3 8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:50844-604-09 4 in 1 CARTON 02/01/2017 4 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:50844-604-56 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 6 NDC:50844-604-14 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 7 NDC:50844-604-16 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 02/01/2017 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50844-417, 50844-604) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(50844-417, 50844-604) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(50844-417, 50844-604) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(50844-417, 50844-604) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(50844-417, 50844-604)