Fulton Street Market Ibuprofen

Access Business Group LLC

Access Business Group LLC Ibuprofen Tablets 200 mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purposes
• Fulton Street Market Ibuprofen 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 Ibuprofen Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Fulton Street Market Ibuprofen 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: Ibuprofen 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 chances are 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

• •you have problems or serious side effects from taking pain relievers or fever reducers
• •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 have asthma
• •you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• •taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• •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
• •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 ibuprofen 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

take 1 tablet every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets in 24 hours, unless directed by a doctorask a doctor

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•

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adults and children 12 years and older
children under 12 years

Fulton Street Market Ibuprofen Other information

• •read all warnings and directions before use
• •store at 20-25°C (68-77°F)
• •avoid high humidity and excessive heat above 40°C (104°F)
• •see end panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

ibuprofen tablets 200 mg

pain reliever/fever reducer (NSAID)

actual size

250 TABLETS – 200 mg EACH

See New Warnings Information

Fulton Street Market Ibuprofen Ibuprofen TABLET, FILM COATED Product Information Product Type Human otc drug label Item Code (Source) NDC:10056-557 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM HYPROMELLOSES cellulose, microcrystalline STEARIC ACID titanium dioxide polysorbate 80 POLYETHYLENE GLYCOLS ferric oxide red FERRIC OXIDE YELLOW Product Characteristics Color Size Imprint Code Shape BROWN 10 mm I2 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 250 in 1 BOTTLE 2 NDC:10056-557-85 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072096 1991-01-15