Drugplain

Childrens MOTRIN 100 mg/5mL

Ibuprofen · SUSPENSION · Kenvue Brands LLC

No Recall History
Plain English

Children's Motrin is an over-the-counter liquid suspension containing ibuprofen that helps reduce fever and relieve pain in children. It belongs to a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

Key Facts

Brand Name
Childrens MOTRIN
Generic Name
Ibuprofen
NDC Code (Product)
50580-601
Manufacturer
Kenvue Brands LLC
Strength
100 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
NDA020516
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
09/01/1995

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15,638 reports
pain14,889 reports
fatigue14,257 reports
nausea13,296 reports
headache11,944 reports
arthralgia10,759 reports
dyspnoea10,396 reports
vomiting10,006 reports
diarrhoea9,602 reports
rash9,003 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions 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 Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor 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

Warnings

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 a

Frequently Asked Questions

What is Childrens MOTRIN used for?

Children's Motrin is an over-the-counter liquid suspension containing ibuprofen that helps reduce fever and relieve pain in children. It belongs to a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

Is Childrens MOTRIN a controlled substance?

Childrens MOTRIN is not classified as a controlled substance by the DEA.

What is the generic name for Childrens MOTRIN?

The generic name for Childrens MOTRIN is Ibuprofen. There are 12 other brand versions of Ibuprofen.

What is the NDC code for Childrens MOTRIN 100 mg/5mL?

The NDC (National Drug Code) for Childrens MOTRIN 100 mg/5mL is 50580-601, listed by Kenvue Brands LLC.