Ibuprofen Oral Suspension, USP
Drug Labeling and Warnings
Drug Details [pdf]
CHILDRENS IBUPROFEN- ibuprofen suspension
Actavis Pharma, Inc.
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Ibuprofen Oral Suspension, USP
Active ingredient
(in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
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 ▪ 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
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)
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)* |
| 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 |
| *or as directed by a doctor | ||
Other information
each 5 mL contains: sodium 2 mg
store between 20° to 25°C (68° to 77°F)
do not use if printed neckband is broken or missing
see bottom panel for lot number and expiration date
Inactive ingredients
Original Berry: 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: citric acid, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
Grape: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
Bubble Gum: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
PRINCIPAL DISPLAY PANEL
Actavis™
Compare to the active ingredient in Children’s Motrin® Berry†
NDC 0472-1255-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Original Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
original berry
PRINCIPAL DISPLAY PANEL
Actavis™
Compare to the active ingredient in Children’s Motrin® Dye Free Berry†
NDC 0472-1261-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Non-Staining
Dye-Free Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
dye-free berry
PRINCIPAL DISPLAY PANEL
Actavis™
Compare to the active ingredient in Children’s Motrin® Grape†
NDC 0472-1262-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Grape Flavor
Alcohol Free
4 FL OZ (118 mL)
PRINCIPAL DISPLAY PANEL
Actavis™
Compare to the active ingredient in Children’s Motrin® Bubble Gum†
NDC 0472-1263-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Bubble Gum Flavor
Alcohol Free
4 FL OZ (118 mL)
bubble gum
| CHILDRENS IBUPROFEN
ibuprofen suspension |
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| Labeler - Actavis Pharma, Inc. (119723554) |
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