Fulton Street Market Naproxen Sodium

Access Business Group LLC

Access Business Group LLC Naproxen Sodium Tablets Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purposes
• Fulton Street Market Naproxen Sodium Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Fulton Street Market Naproxen Sodium Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

•  Naproxen sodium 220 mg
•  (naproxen 200 mg) (NSAID)*
•  *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Fulton Street Market Naproxen Sodium 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

take 1 caplet every 8 to 12 hours while symptoms last

for the first dose you may take 2 caplets within the first hour

do not exceed 2 caplets in any 8- to 12-hour period

do not exceed 3 caplets in a 24-hour periodask a doctor

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Adults and children 12 years and older:
Children under 12 years:

Fulton Street Market Naproxen Sodium Other information

• •each caplet 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

Questions or comments?

1-800-719-9260

Principal Display Panel

all day pain relief

naproxen sodium tablets, 220 mg

pain reliever/fever reducer (NSAID)

non prescription strength

8 – 12 hour relief

See New Warnings Information

actual size

200 CAPLETS** - 220 mg EACH

(**capsule-shaped tablets)

Fulton Street Market Naproxen Sodium Naproxen Sodium TABLET, FILM COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:10056-400 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength naproxen sodium NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MAGNESIUM STEARATE cellulose, microcrystalline POLYETHYLENE GLYCOLS POVIDONES talc titanium dioxide Product Characteristics Color Size Imprint Code Shape BLUE (Light Blue) 12 mm L368 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 200 in 1 BOTTLE 2 NDC:10056-400-82 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074661 2000-07-06