FDA Label for Childrens Ibuprofen Oral Suspension

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH 5 ML)
USES
ALLERGY ALERT
STOMACH BLEEDING WARNING
HEART ATTACK AND STROKE WARNING
SORE THROAT WARNING
DO NOT USE
ASK A DOCTOR BEFORE USE IF
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL

Childrens Ibuprofen Oral Suspension Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutical Associates, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredient (In Each 5 Ml)

Uses

temporarily:

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

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

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

Otc - 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 (1-800-222-1222) right away.

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.
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

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)

Children's Ibuprofen Oral Suspension is purple, grape flavored suspension supplied in the following oral dosage forms:

NDC 0121-1828-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, distributor of Children’s Motrin®

Principal Display Panel

Delivers 5 mL

NDC 0121-0914-05

Children's Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain reliever/Fever reducer

Grape/Flavored/Alcohol Free

SHAKE WELL

FOR INSTITUTIONAL USE ONLY

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

Delivers 10 mL

NDC 0121-1828-10