EQUALINE NAPROXEN SODIUM - naproxen sodium capsule, liquid filled
Supervalu Inc

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Active ingredient (in each capsule)

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:
headache
muscular aches
minor pain of arthritis
toothache
backache
the common cold
menstrual cramps
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
stomach pain or upset gets worse or lasts
redness or swelling is present in the painful area
any new symptoms appear
you have difficulty swallowing
it feels like the capsule is stuck in your throat

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
if taken with food, this product may take longer to work

adults and

children 12 years

and older:

take 1 capsule every 8 to 12 hours while symptoms last
for the first dose you may take 2 capsules within the first hour
do not exceed 2 capsules in any 8- to 12 hour period
do not exceed 3 capsules in a 24 hour period

children

under 12

years:

ask a doctor

Other information

each capsule contains: sodium 20 mg
store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
do not use if printed foil under cap is broken or missing
read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-877-932-7948

Package/Label Principal Display Panel

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

Actual Size

**Liquid Filled Capsules

See New Warnings Information

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 1

Naproxen Sodium Capsules, 220 mg (NSAID) Carton Image 2

EQUALINE NAPROXEN SODIUM
naproxen sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-742
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (NAPROXEN)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
LACTIC ACID
MANNITOL
POLYETHYLENE GLYCOL
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL

Product Characteristics
Color	BLUE (Clear)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	742
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41163-742-58	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		40 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	This package is contained within the CARTON (41163-742-58)
2	NDC:41163-742-71	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		50 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	This package is contained within the CARTON (41163-742-71)
3	NDC:41163-742-27	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
3		80 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	This package is contained within the CARTON (41163-742-27)
4	NDC:41163-742-78	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
4		100 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	This package is contained within the CARTON (41163-742-78)
5	NDC:41163-742-06	160 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021920	11/23/2010

Labeler - Supervalu Inc (006961411)

Revised: 12/2010 Supervalu Inc