NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER- naproxen sodium tablet

Naproxen Sodium (NSAID) by

Drug Labeling and Warnings

Naproxen Sodium (NSAID) by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals of New York LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Compared to the active ingredient of Aleve® †

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Naproxen sodium USP, 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATION AND USAGE

Uses

• temporarily relieves minor aches and pains due to:
• backache
• muscular aches
• minor pain of arthritis
• 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

Heart attack and stroke warning: NSAID, 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 DOCTOR/PHARMACIST

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, 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

WHEN USING

When using this product

• take with food or milk if stomach upset occurs

STOP USE

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:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
• 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

• each tablet contains: sodium 20 mg
• store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9 AM – 5 PM EST.

SPL UNCLASSIFIED SECTION

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

SPL UNCLASSIFIED SECTION

†This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

Rev. 11-2017-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 53746-191-24

Naproxen Sodium Tablets USP (NSAID), 220 mg

24 Tablets

Amneal Pharmaceuticals

NDC: 53746-192-24

Naproxen Sodium Tablets USP (NSAID), 220 mg

24 Caplets

Amneal Pharmaceuticals

 

 

 

 

NDC: 53746-191-24

Naproxen Sodium Tablets USP (NSAID), 220 mg

24 Tablets

Amneal Pharmaceuticals

NDC: 53746-192-24

Naproxen Sodium Tablets USP (NSAID), 220 mg

24 Caplets

Amneal Pharmaceuticals

Purse Pack

NDC: 53746-191-08

Naproxen Sodium Tablets USP (NSAID), 220 mg

8 Tablets

Amneal Pharmaceuticals

Purse Pack

NDC: 53746-192-08

Naproxen Sodium Tablets USP (NSAID), 220 mg

8 Caplets

Amneal Pharmaceuticals

Purse Pack

NDC: 53746-191-16

Naproxen Sodium Tablets USP (NSAID), 220 mg

16 Tablets

Amneal Pharmaceuticals

Purse Pack

NDC: 53746-192-16

Naproxen Sodium Tablets USP (NSAID), 220 mg

16 Caplets

Amneal Pharmaceuticals

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-191
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
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 (Biconvex)	Size	10mm
Flavor		Imprint Code	I3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-191-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2009
2	NDC: 53746-191-08	8 in 1 VIAL; Type 0: Not a Combination Product	11/25/2009
3	NDC: 53746-191-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079096	11/25/2009

NAPROXEN SODIUM (NSAID)  FEVER REDUCER/ PAIN RELIEVER
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-192
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
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	OVAL (Biconvex)	Size	12mm
Flavor		Imprint Code	I7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-192-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2009
2	NDC: 53746-192-08	8 in 1 VIAL; Type 0: Not a Combination Product	11/25/2009
3	NDC: 53746-192-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079096	11/25/2009

Labeler - Amneal Pharmaceuticals of New York LLC (123797875)