Naproxen Sodium by Northwind Pharmaceuticals, LLC NAPROXEN SODIUM tablet

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications and Usage

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

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)

Dosage

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).

Inactive ingredients

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

Label

NDC: 51655-624-24

MFG: 45802-490-78

Naproxen Sodium 220 MG

24 Tablets

OTC

Lot#

Exp. Date:

Each tablet contains naproxen sodium....220 mg

Sodium....21 mg

Dosage: See prescribing information.

Store at 68 to 77 degrees F

Store in a tight, light-resistant container. Protect from moisture.

Keep out of the reach of children.

Distributed by: Perrigo, Allergan, MI 49010

Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-624(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	220 mg

Product Characteristics
Color	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: 51655-624-24	24 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074661	07/14/2014

Labeler - Northwind Pharmaceuticals, LLC (036986393)

Registrant - Northwind Pharmaceuticals, LLC (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals, LLC		036986393	repack(51655-624)