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IBUPROFEN by DIRECT RX

Medically reviewed on November 3, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: DIRECT RX
NDC Code: 61919-123

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

IBUPROFEN

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION
  • 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 SECTION

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:

  • 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

  • right before or after heart surgery

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if you have

  • 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 are taking a diuretic

  • you have asthma

  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • taking any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor"s care for any serious condition

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 or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:

    • feel faint

    • have bloody or black stools

    • vomit blood

    • 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 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 right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

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

right before or after heart surgery

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if you have

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 are taking a diuretic

you have asthma

you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are
taking any other drug
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor"s care for any serious condition

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 or for longer than directed

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

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 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 right away.

OTC - WHEN USING SECTION
  • 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

INFORMATION FOR PATIENTS SECTION
  • store between 20°-25°C (68°-77°F)

  • avoid excessive heat 40°C (104°F)

  • use by expiration date on package

DOSAGE & ADMINISTRATION SECTION


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

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

(800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-123(NDC:0904-7915)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-123-3030 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-123), repack(61919-123)

 
DIRECT RX

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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