1. Home
  2. Labeler Index
  3. Walgreens
  4. 0363-9600
  5. Label Information: Ibuprofen

FDA Label for Ibuprofen

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. IBUPROFEN 200 MG CAPLETS -600R INACTIVE INGREDIENTS
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. OTC - PURPOSE
    6. WARNINGS
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. IBUPROFEN CAPLETS 200 MG 600R - 24 COUNT
    9. IBUPROFEN 200 MG CAPLET 600R 50 COUNT
    10. IBUPROFEN 200 MG CAPLETS 600R 100 COUNT
    11. IBUPROFEN 200 MG CAPLETS 600R 300 COUNT LABEL
    12. IBUPROFEN 200 MG CAPLETS 600R 500 COUNT

Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 Caplets -600R 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 caplet every 4 to 6 hours while symptom persist
  • If pain does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets 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.