Naproxen Sodium 220Mg (Naproxen Sodium) Tablet [Medline Industries] -

NAPROXEN SODIUM 220MG (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES]
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NDC	53329-678-30
Set ID	66d494ce-f79d-1e7a-e053-2a91aa0a78b7
Category	HUMAN OTC DRUG LABEL
Packager	Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number	ANDA091353

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Active ingredient

Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID) *non steroidal 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 ■ have 3 or
more alcoholic drinks every day while using this product ■ take other drugs containing
prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ take
more or for a longer time than directed. 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 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
■ you are taking a diuretic

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

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 ■ slurred speech
■ trouble breathing ■ leg swelling
■ weakness in one part or side of body
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present in the painful area
■ any new symptoms appear
■ you have difficulty swallowing
■ it feels like the pill 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 ■ 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

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 ingredients

FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?

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NDC 53329-678-30

MEDLINE

Naproxen Sodium

(NSAID)

Pain reliever/ Fever reducer

Strength to last 12 hours

Compare to the active ingredient in Aleve (R)

100 tablets

220mg

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 220MG
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-678
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	220
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-678-30	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2018	05/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091353	03/07/2018	05/31/2022

Labeler - Medline Industries, LP (025460908)

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Medic

NAPROXEN SODIUM 220MG (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES]

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