childrens ibuprofen
CVS Pharmacy, Inc. Children’s Ibuprofen Drug Facts
884d51d8-4774-4dde-b854-32abfb4b712d
HUMAN OTC DRUG LABEL
May 20, 2025
CVS Pharmacy
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
CVS Health®
Compare to the active ingredient in Children’s Motrin®
Chewables
For ages 2-11
Children’s Ibuprofen
CHEWABLE TABLETS, 100 mg
LASTS UP TO 8 HOURS
Pain reliever; Fever reducer (NSAID)
Chew or crush tablets completely before swallowing
24 CHEWABLE TABLETS
Actual Size
Orange Flavor
INDICATIONS & USAGE SECTION
Uses
temporarily:
•
reduces fever
•
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
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
•
mouth or throat burning may occur; give with food or water
•
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:
•
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)
DOSAGE & ADMINISTRATION SECTION
Directions
•
**chew or crush tablets completely before swallowing**
•
**this product does not contain directions or complete warnings for adult use**
•
**do not give more than directed**
•
find right dose on chart below. If possible, use weight to dose; otherwise use age.
•
if needed, repeat dose every**6-8 hours**
•
do not use more than**4 times a day**
|
Dosing Chart | ||
|
Weight (lb) |
Age (yr) |
Tablets |
|
under 24 |
under 2 |
ask a doctor |
|
24-35 |
2-3 |
1 |
|
36-47 |
4-5 |
1 ½ |
|
48-59 |
6-8 |
2 |
|
60-71 |
9-10 |
2 ½ |
|
72-95 |
11 |
3 |
STORAGE AND HANDLING SECTION
Other information
•
phenylketonurics: contains phenylalanine 6 mg per tablet
•
store between 20-25°C (68-77°F)
•
**do not use if printed seal under cap is broken or missing**
INACTIVE INGREDIENT SECTION
Inactive ingredients
acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
OTC - QUESTIONS SECTION
Questions or comments?
1-800-719-9260