IBUPROFEN tablet, film coated

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Breeden Brothers, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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Active ingredient (in each brown tablet)

Ibuprofen USP,

200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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• 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

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See carton for complete warnings (short label only) 
See vial card for complete warnings (vial label only)
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                    74 words
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,        37 words
and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

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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

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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

Ask a doctor or pharmacist before use if you are

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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

When using this product

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take with food or milk if stomach upset occurs 

Stop use and ask a doctor if

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• 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
  

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not              70 words
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 (1-800-222-1222) right away.

Directions

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• 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

• 63 words
  TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING (short label only)
  
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN (blister package only)
  
• store between 20˚-25˚C (68˚-77˚F)
  
• avoid excessive heat 40˚C (104˚F)
  
• see end flap for expiration date and lot number (carton only)
  
• use by expiration date on package (vial card, vial label & label only)
  

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose                29 words
anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
(or specific to customer’s labeling guide)

Additional Information:
Change to version 44-291.09 BBW1116
In Legend Box update DF version to 44-291.09

PRINCIPAL DISPLAY PANEL

NDC: 70729-291-12
b + b
IBUPROFEN
Ibuprofen Tablets USP, 200 mg
Pain Reliever/ Fever Reducer
(NSAID)
100 Tablets

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70729-291
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70729-291-12	1 in 1 CARTON	05/24/1988
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075010	05/24/1988

Labeler - Breeden Brothers, LLC (080131046)