FDA Label for Naproxen

Other

Drug Facts

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: 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.

Active Ingredient (In Each Tablet)

Naproxen sodium 220 mg (NSAID)**

Purposes

Pain reliever/fever reducer (naproxen 200 mg) ** nonsteroidal anti-inflammatory drug

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
  
  

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 had 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 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
  • 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
  
  

Otc - 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.

Otc - 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 under12 years	ask a doctor

Other Information

• each tablet contains: sodium 20 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#2 aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

Call toll free: 1-800-456-7077

Principal Display Panel – Pouch Label

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Naproxen Sodium Tablets USP, 220 mg (NSAID)**

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

Contains no Ingredient made from a
gluten-containing grain (wheat, barley, or rye)

1 Tablet

Principal Display Panel – Pouch Label - nap07 0001 01

Principal Display Panel – 50-Pouch Carton Label

Safetec^®
of America, Inc.

Compare to the active ingredient
in Aleve^® Tablets*

NDC 61010-4410-1

STRENGTH TO LAST 12 HOURS

Naproxen Sodium

Tablets USP, 220 mg (NSAID)**

Pain Reliever/Fever Reducer

PUSH TO OPEN

Dispense through
opening

Contains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)

• Relieves minor aches and pains
• Fever reducer
• Lasts up to 12 hours

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches

1 Tablet per Pouch

Principal Display Panel – 50-Pouch Carton Label - nap07 0001 02

Principal Display Panel – 100-Pouch Carton Label

Safetec^®
of America, Inc.

Compare to the active ingredient
in Aleve^® Tablets*

NDC 61010-4410-2

STRENGTH TO LAST 12 HOURS

Naproxen Sodium

Tablets USP, 220 mg (NSAID)**

Pain Reliever/Fever Reducer

Contains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)

• Relieves minor aches and pains
• Fever reducer
• Lasts up to 12 hours

PUSH TO OPEN

Dispense
through
opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches

1 Tablet per Pouch

Principal Display Panel – 100-Pouch Carton Label - nap07 0001 03