Ibuprofen by Amneal Pharmaceuticals of New York LLC 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient 

(in each tablet)

Ibuprofen USP, 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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
• take 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.

Do not use

• if you have ever had an allergic reaction to ibuprofen or 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, kidney disease, asthma, or had a stroke
  
• 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
  

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 at 20 weeks or later in 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)

Directions

• do not take more than directed

• the smallest effective dose should be used

• adults and children 12 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 between 20° to 25°C (68° to 77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients

Brown Tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, pregelatinized starch, stearic acid, talc, titanium dioxide, triglycerides

Orange Tablets: colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, pregelatinized starch, stearic acid, talc, titanium dioxide, triglycerides

White Tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, 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 Motrin IB®

Distributed By:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 10-2022-00

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC: 53746-462-02

Ibuprofen Tablets USP, 200 mg

250 Tablets

Amneal Pharmaceuticals LLC

 

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC: 53746-460-02

Ibuprofen Tablets USP, 200 mg

250 Tablets

Amneal Pharmaceuticals LLC

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC: 53746-458-02

Ibuprofen Tablets USP, 200 mg

250 Tablets

Amneal Pharmaceuticals LLC

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-462
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	IP;462
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-462-02	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013
2	NDC: 53746-462-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079233	04/30/2013

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-460
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	IP;462
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-460-02	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013
2	NDC: 53746-460-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079233	04/30/2013

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53746-458
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	IP;462
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53746-458-02	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013
2	NDC: 53746-458-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079233	04/30/2013

Labeler - Amneal Pharmaceuticals of New York LLC (123797875)