Ibuprofen Tablet
FDA Label NDC 25000-135

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Ibuprofen (NDC 25000-135). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredient(s)

→ Storage

→ Principal Display Panel

Active Ingredient(S)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(S)

temporarily relieves minor aches and pains due to:
- backache
- headache
- menstrual cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic 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 an 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 or nonprescription 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 for longer than directed.

Do Not Use

if you have ever had an allergic reaction to ibuprofen or 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, or 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 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 problem 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 painful area
  - any new symptoms appear

Pregnancy/Breastfeeding

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 a 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 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	ask a doctor

Inactive Ingredient(S)

Silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.