Ibuprofen Tablet
FDA Label NDC 87509-0004

11 label sections · Submitted to the FDA by Famora Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Famora Inc for the product Ibuprofen (NDC 87509-0004). 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 drug facts, active ingredients (in each tablet), purpose, uses, warnings, otc - pregnancy or breast feeding, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

  •  temporarily relieves minor aches and pains due to:
  •  headache
  •  toothache
  • backache
  •  menstrual cramps
  •  the common cold
  •  muscular aches
  •  minor pain of arthritis
  •  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 a nonsteroidal anti-inflammatory drug (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

Otc - Pregnancy Or Breast Feeding

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.

Directions

  • 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 or fever does not respond to1 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

  • store between 20˚-25˚C (68˚-77˚F)
  •  **Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C yellow #5 (tartrazine)**, FD&C yellow #6, iron oxide red, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

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