Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
equate ibuprofen childrens
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
equate™
Compare to Children’s Motrin® active ingredient
Children’s Ibuprofen
Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID)
AGES 2 to 11 YEARS
LASTS UP TO 8 HOURS
• Alcohol Free
Grape Flavored
4 FL OZ (118 mL)
Dosage Cup Included
INDICATIONS & USAGE SECTION
Uses
temporarily:
•
relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
•
reduces fever
DOSAGE & ADMINISTRATION SECTION
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**
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replace original bottle cap to maintain child resistance
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wash dosage cup after each use
|
Dosing Chart | ||
|
Weight (lb) |
Age (yr) |
Dose (mL)** |
|
under 24 lbs |
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
WARNINGS SECTION
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
•
give 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:
•
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
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)
STORAGE AND HANDLING SECTION
Other information
•
**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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
OTC - QUESTIONS SECTION
Questions or comments?
1-888-287-1915
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial grape flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum