IBUPROFEN PAIN RELEIVER/ FEVER REDUCER- ibuprofen tablet

Ibuprofen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

(in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATIONS AND USAGE

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 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
• takes 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.

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, asthma, or had a stroke
• 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 stomach upset occurs

OTC - STOP USE

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
• redness or swelling is present in the painful area
• any new symptoms appear

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.

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. (1-800-222-1222)

DOSAGE AND ADMINISTRATION

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

• adults and children12 years and over:
  • 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

• read all warnings and directions before use
• store at 20° to 25°C (68° to 77°F)
• avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

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

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

SPL UNCLASSIFIED SECTION

Distributed By:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

Rev. 02-2018-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 53746-140-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

NDC: 53746-140-24

Ibuprofen Tablets USP, 200 mg

24 Tablets

Amneal Pharmaceuticals LLC

 

INGREDIENTS AND APPEARANCE

IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-140
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-140-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009
2	NDC: 53746-140-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009
3	NDC: 53746-140-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009

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

IBUPROFEN  PAIN RELEIVER/ FEVER REDUCER
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-143
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-143-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009
2	NDC: 53746-143-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009
3	NDC: 53746-143-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2009

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

Labeler - Amneal Pharmaceuticals of New York LLC (123797875)