IBUPROFEN 200MG- 383 ibuprofen 200mg tablet

Ibuprofen 200mg by

Drug Labeling and Warnings

Ibuprofen 200mg by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ibuprofen USP, 200mg (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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 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, or kidney disease
• you have asthma
• you are taking a diuretic 

Ask a doctor or pharmacist before use if

• 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

• take with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke
  

Stop use and ask a doctor if

• you feel  faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset getsworse or lasts
• redness or swelling is present in the painful area
• any new symptoms appear

Pregnancy/Breastfeeding

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).

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

• store between 20-25 °C (68-77° F).
• Read all warnings and directions before use
• Do not use if seal under bottle cap is broken or missing.

Inactive ingredients

colloidal silicon dioxide, pregelatinized starch, titanium dioxide

May contain: corn starch, croscarmellose sodium, FD&C yellow #6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, stearic acid, talc, triacetin

Questions or Comments?

Call 1-888-952-0050

Monday through Friday 9AM – 5PM EST

Principal Display Panel

Ibuprofen 200mg

INGREDIENTS AND APPEARANCE

IBUPROFEN 200MG 
383 ibuprofen 200mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-383
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
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
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-383-40	1 in 1 CARTON	12/23/2014
1		40 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69168-383-30	1 in 1 CARTON	12/23/2014
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69168-383-01	1 in 1 CARTON	12/23/2014
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69168-383-03	250 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091239	12/23/2014

Labeler - Allegiant Health (079501930)