Ibuprofen Tablet
FDA Label NDC 0363-9601

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Ibuprofen (NDC 0363-9601). 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 otc - active ingredient, ibuprofen 200 mg tablet inactive ingredients, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, ibuprofen 200 mg tablets 24 count, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Solubilized Ibuprofen equal to

200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Ibuprofen 200 Mg Tablet Inactive Ingredients

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

Dosage & Administration

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 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

Indications & Usage

Temporarily relieves minor aches and pain due to :

  • headache
  • toothache
  • backache

    • menstrual cramps
      • the common cold
      • muscular aches
      • minor pain of arthritis

        • Temporarily reduces fever

Otc - Purpose

PAIN RELIEVER/ FEVER REDUCER

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 a NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have bad stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing 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

Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

Otc - Keep Out Of Reach Of Children

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

* Please review the disclaimer below.