Ibuprofen Tablet
FDA Label NDC 55681-401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Ibuprofen (NDC 55681-401). 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/caplet), purpose, uses, warnings, do not use, ask a 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/Caplet)

Ibuprofen 200 mg (NSAID) *

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • 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 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

      • Heart attack and stroke warning
      NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 A 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, kidney disease, asthma, or had a stroke
  • 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

Stop Use And Ask A 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
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • 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 at 20 weeks or later in 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 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever 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

Other

Other Information

  • store at 20-25°C (68-77°F)[See USP Controlled Room Temperature]
  • avoid high humidity and excessive heat above 40°C (104°F)

    • Distributed by: Twin Med LLC

    Santa Fe Springs, CA 90670
    www.procureproducts.com

    ITEM# PCOTC200 MADE IN INDIA

Inactive Ingredients

colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

call toll-free 1-844-912-4012

Package Label.Principal Display Panel



NDC# 55681-401-03

See New Warnings Information



IBUPROFEN TABLETS USP, 200 mg



Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a
gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

250 Coated Caplets †

†Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

* Please review the disclaimer below.