Ibuprofen Tablet
FDA Label NDC 10267-3909

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacal Corp. for the product Ibuprofen (NDC 10267-3909). 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 (in each tablet), purpose, uses, warnings, do not use, ask doctor before use if, ask a doctor or pharmacist before use if you are, 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 (In Each Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular ache
  • 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 an NSAID, which may cause severe 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
    • take more or for longer time than directed

Do Not Use

  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask 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 You Are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor’s care for any serious condition
  • 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 A Doctor If

  • you experience and 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 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 (1-800-222-1222) right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used

    • Adults and children 12 years of age 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 of age: ■ Ask a doctor

Inactive Ingredients

(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

Questions Or Comments?

Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

Package Label.Principal Display Panel

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3909-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
DYE-FREE
NOT ACTUAL SIZE

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3846-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE

New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3852-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREE

Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE

* Please review the disclaimer below.