Medicine guide

Leader Ibuprofen

100 mg/5mL · Suspension

  • Available without prescription
  • Nonsteroidal Anti-inflammatory Drug
Active substance
Ibuprofen
Made by
Cardinal Health 110, LLC. dba Leader

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-06-26

What it is

Pain reliever/fever reducer

Used for
  • Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
How to take it

5 mL

do not use more than 4 times a day

Full directions ↓
Do not take it if

If the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer

All warnings ↓
What it looks like
Colour
pink
Flavour
bubble gum

From the manufacturer’s submission to the FDA. Always compare with your own pack — a different maker’s tablet can look different.

Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
676other products contain Ibuprofen — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever

From the official label · 2025-06-26 · DailyMed

How it works

From the US prescribing label for the same active substance (Ibuprofen). It describes the substance, not this exact product.

Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities.

Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.

Half-life1.8–2.0 h
Mostly cleared after≈ 9.5 hfive half-lives — our arithmetic
How the body breaks it down

Ibuprofen is rapidly metabolized and eliminated in the urine.

With food

When ibuprofen is administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-02-17

Do not take it if

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

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use
  • Dosing Chart
  • Weight (lb)
  • Age (yr)
  • Dose (mL)**
  • under 24 lbs
  • under 2 years
  • 24-35 lbs
  • 2-3 years
  • 5 mL
  • 36-47 lbs
  • 4-5 years
  • 7.5 mL
  • 48-59 lbs
  • 6-8 years
  • 10 mL
  • 60-71 lbs
  • 9-10 years
  • 12.5 mL
  • 72-95 lbs
  • 11 years
  • 15 mL
  • **or as directed by a doctor

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
  • child has asthma
  • child is taking a diuretic

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

  • under a doctor’s care for any serious condition
  • taking any other drug

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • the child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

Quoted from the official label, section “OTC — Stop Use”.

Other 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 your child:
  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes 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.
  • Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
  • give with food or milk if stomach upset occurs

Quoted from the official label, section “Warnings”.

Keep away from children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

How to store it

  • each 5 mL contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not freeze

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Pain reliever/fever reducer

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Quoted from the official label, section “Inactive Ingredients”.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

Details

Made byCardinal Health 110, LLC. dba Leader
Active substanceIbuprofen
Used inMuscles, joints and bones
Strength100 mg/5mL
FormSuspension
RouteOral
Packs1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
NDC70000-0262
NDC70000-0264

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

  • Suspension1 products
    • 100 mg/5mL
  • Tablet, Film Coated1 products
  • Tablet, Chewable1 products

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.