IBUPROFEN PAIN RELIEVER/FEVER REDUCER- ibuprofen capsule, liquid filled

Ibuprofen Pain Reliever/Fever Reducer by

Drug Labeling and Warnings

Ibuprofen Pain Reliever/Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

(in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE

Pain reliever/Fever reducer

INDICATIONS AND USAGE

• temporarily relieves minor aches and pains due to:
• headache
• toothache
• backache
• menstrual cramps
• the common cold
• muscular aches
• minor pain of arthritis
• 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 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

OTC - DO NOT USE

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

OTC - ASK DOCTOR

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
• you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

OTC - WHEN USING

When using this product

• take with food or milk if upset stomach occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

OTC - STOP USE

Stop use and ask a doctor if

• you experience any of the follwing 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

OTC - PREGNANCY OR BREAST FEEDING

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.

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 (1-800-222-1222) right away.

DOSAGE AND ADMINISTRATION

DIRECTIONS

• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used.
• do not exceed 6 capsules in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

OTHER INFORMATION

• each capsule contains: potassium 20 mg
• read all warnings and directions before use.  Keep carton.
• Store at 20º to 25ºC (68º to 77ºF)
• avoid excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENTS

D&C Yellow # 10, FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

OTC – QUESTIONS OR COMMENTS?

Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Do Not Use if printed foil under cap is broken or missing.

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY  42141

Rev. 08-2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN PAIN RELIEVER/FEVER REDUCER 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-770
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	TURQUOISE	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	A;77
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-770-02	1 in 1 CARTON	12/23/2011
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 65162-770-69	1 in 1 CARTON	12/23/2011
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 65162-770-11	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2011
4	NDC: 65162-770-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202300	12/23/2011

Labeler - Amneal Pharmaceuticals LLC (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals of New York, LLC		123797875	ANALYSIS(65162-770, 65162-770) , LABEL(65162-770, 65162-770) , MANUFACTURE(65162-770, 65162-770) , PACK(65162-770, 65162-770)