Ibuprofen
FDA Label NDC 52605-114

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Polygen Pharmaceuticals Llc for the product Ibuprofen (NDC 52605-114). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)


Ibuprofen 200 mg (NSAID)*

 * nonsteroidal anti-inflammatory drug


Purpose


Pain reliever/Fever reducer


Use(S)

temporarily relieves minor aches and pain due to:

  • backache
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

    • If an allergic reaction occurs, stop use and seek medical help right away.


    Stomach bleeding warning:     This product contains an NSAID, which may cause 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the more or for a longer time 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
  • you have a history of stomach problems such as heartburn
  • the stomach bleeding warning applies to you
  • you have high blood pressure, heart disease , kidney disease, liver cirrhosis  
  • you are taking  a diuretic
  • you have asthma

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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask 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 occur

    • Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding


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. (1-800-222-1222)


Directions


  • do not take more than directed
  • the smallest effective dose should be used
    • adults and children
    12 years and older:
    		· 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

  •  do not use if seal under cap is broken or missing
  • see end panel for lot number and expiration date


Inactive Ingredient


colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage

  • store between 20-25 °C (68-77 ° F).

Questions


1-888-291-7337


Principal Display Panel


CARTON LABEL PDP

 

NDC: 52605-114-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION
 


Ibuprofen (Ibuprofencarton)

Ibuprofen (Ibuprofencarton)



BOTTLE LABEL PDP

NDC: 52605-114-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION



Ibu200tabbottlab (Ibubottlelabel)

Ibu200tabbottlab (Ibubottlelabel)



CARTON LABEL PDP

 

NDC: 52605-117-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



Ibucarton100 (Ibucapletcarton1)

Ibucarton100 (Ibucapletcarton1)







BOTTLE LABEL PDP

NDC: 52605-117-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



Ibubott100 (Ibucapletbottlelabel1)

Ibubott100 (Ibucapletbottlelabel1)





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