Ibuprofen by New World Imports IBUPROFEN tablet

Ibuprofen by

Drug Labeling and Warnings

Ibuprofen by is a Otc medication manufactured, distributed, or labeled by New World Imports. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ibuprofen 200mg  (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever / fever reducer

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)

INDICATIONS & USAGE

Temporarily relieves minor aches and pains due to:

Headache, muscular aches, minor pain of arthritis, toothache, backache, common cold and 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, 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 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen,  naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed.

Do not use if you have ever had a n allergic reaction to any other pain reliever / fever reducer or right before / 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 haev a history of stomach problems, such as heartburn, you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.  You have asthma.  You are taking a diuretic.

Ask a doctor or pharmacist before use if you are:taking aspirin to prevent 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. The risk of heart attack or stroke may increase if you use more than directed of for longer than directed.

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.  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.

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.

DOSAGE & ADMINISTRATION

Do not take more than directed.  The smallest effective dose should be used. 

Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablets, 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

INACTIVE INGREDIENT

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, pregelantinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

OTHER SAFETY INFORMATION

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Read all warnings and directions before use

Do not use if seal under bottle cap is broken or missing

QUESTIONS

Questions or Comments: Call 1-888-952-0050  Monday through Friday 9 AM - 5 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-018
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)
Starch, Corn (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
Ferric Oxide Red (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown (Rusty brown color)	Score	no score
Shape	ROUND (Round)	Size	10mm
Flavor		Imprint Code	IBU200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-018-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2012	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/05/2012	08/01/2020

Labeler - New World Imports (075372276)