Childrens Ibuprofen Oral Suspension
200 mg/10mL · Suspension
- Available without prescription
- Nonsteroidal Anti-inflammatory Drug
- Active substance
- Ibuprofen
- Used in
- Muscles, joints and bones
- Made by
- PAI Holdings, LLC dba PAI Pharma
- Source
- Official label
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 · 2025-08-01
Pain reliever/fever reducer
- Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Ask a doctor 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
do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL) * under 24 under 2 years
Full directions ↓If the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
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 · 2025-08-01 · 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.
Ibuprofen is rapidly metabolized and eliminated in the urine.
When ibuprofen tablets are 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 · 2026-09-08
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 below.
- 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 Dosing Chart Weight (lb) Age (yr) Dose (mL) * under 24 under 2 years
- ask a doctor 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
the child is 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.
- Do not use if the child has 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 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
- Ask a doctor or pharmacist before use if the child is 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 child experiences any of the following signs of stomach bleeding:
- Keep out of reach of children.
- (1-800-222-1222)
- take 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
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened or if safety seal under cap printed with “SEALED FOR YOUR PROTECTION” is torn or missing Children’s Ibuprofen Oral Suspension is a white to off-white suspension supplied in the following:
- NDC 0121-0833-04:
- 4 fl oz (120 mL) bottle NDC 0121-0833-81:
- Case contains 12 cartons of NDC 0121-0833-04. NDC 0121-0833-05:
- 5 mL unit dose cup. NDC 0121-0833-00:
- Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-0833-40:
- Case contains 40 unit dose cups of 5 mL packaged in 4 trays of 10 unit dose cups each. NDC 0121-1666-10:
- 10 mL unit dose cup. NDC 0121-1666-00:
- Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each. NDC 0121-1666-40:
- Case contains 40 unit dose cups of 10 mL packaged in 4 trays of 10 unit dose cups each.
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.
avicel, citric acid, glycerin, polysorbate 80, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose, xanthan gum. May contain citric acid and sodium citrate dihydrate for pH adjustment.
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
Call 1-800-845-8210.
Quoted from the official label, section “OTC — Questions”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Sugars
sucrose
Relevant to diabetes and dental health. - Sugar alcohols
sorbitol solution
Sorbitol and similar can upset the stomach and matter with fructose intolerance.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
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 by | PAI Holdings, LLC dba PAI Pharma |
|---|---|
| Active substance | Ibuprofen |
| Used in | Muscles, joints and bones |
| Strength | 200 mg/10mL |
| Form | Suspension |
| Route | Oral |
| Packs | 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE · 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE |
| NDC | 0121-1666 |
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
10 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Suspension10 products
- 100 mg/10mL
- 200 mg/10mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.