NAPROXEN SODIUM tablet, film coated

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have asthma

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 this product

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• 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

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 21 mg
• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
•   Repackaged By: Preferred Pharmaceuticals Inc.

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Aleve® active ingredient

Naproxen Sodium Tablets 220 mg

Actual Size

Pain Reliever/Fever Reducer (NSAID)

Strength to Last 12 Hours

Repackaged By: Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6406(NDC:45802-490)
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6406-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
2	NDC: 68788-6406-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
3	NDC: 68788-6406-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
4	NDC: 68788-6406-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
5	NDC: 68788-6406-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
6	NDC: 68788-6406-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016
7	NDC: 68788-6406-8	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074661	06/09/2016

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-6406)