28dd9baa-43bd-b60a-e063-6394a90a8cf7
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ibuprofen 100 mg (NSAID) 1 nonsteroidal anti-inflammatory drug
Medication Information
Description
Ibuprofen 100 mg (NSAID) 1 nonsteroidal anti-inflammatory drug
Section 50568-5
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
Section 50569-3
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
Section 51727-6
acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
Section 55105-1
Pain reliever/fever reducer
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
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
Drug Facts
Ibuprofen 100 mg (NSAID) 1
nonsteroidal anti-inflammatory drug
Carton Label
Dosing Chart
Other Information
each 5 mL contains: sodium 2 mg
store between 20-25°C (68-77°F)
do not use if carton is opened or printed bottle neckband is broken or missing
Questions Or Comments
Call 1-516-341-0666 9AM-5 PM EST Monday - Friday
Principal Display Panel
NDC 69618-078-54
For Ages 2 to 11 Years
Children’s Ibuprofen Oral Suspension
Oral Suspension (NSAID)
100 mg per 5 mL
Pain Reliever / Fever Reducer
Lasts up to 8 hours
Dye Free
Original Berry Flavor
4 fl oz (118 mL)
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)
Structured Label Content
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
Section 51727-6 (51727-6)
acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
Section 55105-1 (55105-1)
Pain reliever/fever reducer
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
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
Drug Facts
Ibuprofen 100 mg (NSAID) 1
nonsteroidal anti-inflammatory drug
Carton Label
Dosing Chart
Other Information
each 5 mL contains: sodium 2 mg
store between 20-25°C (68-77°F)
do not use if carton is opened or printed bottle neckband is broken or missing
Questions Or Comments (Questions or comments)
Call 1-516-341-0666 9AM-5 PM EST Monday - Friday
Principal Display Panel
NDC 69618-078-54
For Ages 2 to 11 Years
Children’s Ibuprofen Oral Suspension
Oral Suspension (NSAID)
100 mg per 5 mL
Pain Reliever / Fever Reducer
Lasts up to 8 hours
Dye Free
Original Berry Flavor
4 fl oz (118 mL)
Stop Use and Ask A Doctor If (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 (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)
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:22.197532 · Updated: 2026-03-14T23:07:03.829205