Childrens Ibuprofen
FDA Label NDC 76413-344

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Childrens Ibuprofen (NDC 76413-344). 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, purpose, uses, warnings, do not use, ask doctor before use if, ask doctor or pharmacist before use if the child is, 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

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask Doctor Before Use If

→ Ask Doctor Or Pharmacist Before Use If The Child Is

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredient

→ Questions?

→ Principal Display Panel - 100 Mg/5 Ml Bottle Label

Active Ingredient

(in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
shock
asthma (wheezing)
rash
skin reddening
blisters
facial swelling

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

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 any other pain reliever/fever reducer
right before or after heart surgery

Ask 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, or kidney disease
child has asthma
child is taking a diuretic

Ask 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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor 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

the child does not get any relief within the 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

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

this product does not contain directions or complete warnings for adult use
do not give more than directed
shake well before using
find right dose on chart. If possible, use weight to dose; otherwise use age.
use only enclosed measuring cup
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 (tsp or mL)
under 2 years		ask a doctor
24 – 35 lbs	2 – 3 years	1 tsp or 5 mL
36 – 47 lbs	4 – 5 years	1½ tsp or 7.5 mL
48 – 59 lbs	6 – 8 years	2 tsp or 10 mL
60 – 71 lbs	9 – 10 years	2½ tsp or 12.5 mL
72 – 95 lbs	11 years	3 tsp or 15 mL

Other information

each teaspoon contains: sodium 2 mg
do not use if printed neckband is broken or missing
store between 20 - 25°C (68 - 77°F)
see bottom panel for lot number and expiration date

Inactive Ingredient

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.