IBUPROFEN tablet, coated

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each tablet)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

pain reliever/fever reducer

Uses

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

Warnings

Allergy alert: This product may cause a severe allergic reaction, especially in people allergic to aspirin, symptoms may include

• hives
• facial swelling
• asthma(wheezing)
• shock
• skin reddning
• 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.

do not use

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

ask your 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

ask your 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 the benefit of aspirin
• taking any other drug

when using this product

• take with food or milk
• The risk of heart attack or stroke may increase if you are more than directed or for longer than directed

Stop use and ask a doctor if:

• you experience and 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 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 right away.

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 persists.
• 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. keep carton
• store at 20-25 °C (68-77 °F)
• avoid excessive heat above 40°C (104°F)
• do not use if imprinted safety seal under the cap is broken or missing

Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-012-08 – 40 COUNT

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-012
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-012-08	40 in 1 BOTTLE
1		1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091239	07/01/2012

Labeler - Velocity Pharma (962198409)