IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER - ibuprofen tablet 
Amneal Pharmaceuticals

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Ibuprofen Tablets, USP
Fever reducer/ Pain Reliever (NSAID)

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATIONS AND USAGE

• 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 a nonsteroidal anti-inflammatory drug (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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE AND ADMINISTRATION

• do not take more than directed
• the smallest effective dose should be used

Adults and children 12 years and older	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 doctor
Children under 12 years	ask a doctor

OTHER INFORMATION

• Store between 20° to 25°C (68° to 77°F)
• Read all warnings and directions before use

INACTIVE INGREDIENTS

Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch Corn, Titanium Dioxide

 

Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide

 

Questions or Comments

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

Distributed By:

Ameal Pharmaceuticals

Glasgow, KY 42141

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER ibuprofen (nsaid)   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CARNAUBA WAX   SILICON DIOXIDE   HYPROMELLOSES   FERRIC OXIDE RED   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYDEXTROSE   POLYETHYLENE GLYCOL   POVIDONE   SODIUM LAURYL SULFATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STARCH, CORN   TITANIUM DIOXIDE

Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code IP;140 Contains

Packaging # NDC Package Description Multilevel Packaging 1 53746-140-24 24 TABLET In 1 BOTTLE None 2 53746-140-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071333	12/16/2009

IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER ibuprofen (nsaid)   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 53746-143 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CARNAUBA WAX   SILICON DIOXIDE   HYPROMELLOSES   FD&C YELLOW NO. 6   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYDEXTROSE   POLYETHYLENE GLYCOL   POVIDONE   SODIUM LAURYL SULFATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STARCH, CORN   TITANIUM DIOXIDE

Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code IP;143 Contains

Packaging # NDC Package Description Multilevel Packaging 1 53746-143-24 24 TABLET In 1 BOTTLE None 2 53746-143-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071333	12/16/2009

Labeler - Amneal Pharmaceuticals (123797875)

Registrant - Amneal Pharmaceuticals (123797875)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		831227801	ANALYSIS, MANUFACTURE

Revised: 05/2011Amneal Pharmaceuticals