FDA Label for Childrens Ibuprofen

Other

Berry Flavor

100 mg/5 mL 200 mg/10 mL

For Hospital Use Only

Drug Facts

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.

Alcohol Free, Gluten Free

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI587 Rev. 06/23

Active Ingredient (In Each 5 Ml)

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

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

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
    
    

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

Directions

• Use as directed per healthcare professional.
• 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) or as directed by a doctor
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

Other Information

• each 5 mL contains: sodium 2 mg
• store at 20-25°C (68-77°F)
• do not freeze

Inactive Ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments?

1-800-397-9228

How Supplied

NDC 68094-037-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-494-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper

Principal Display Panel - 5 Ml Cup Label

NDC 68094-494-59
PrecisionDose™

Children's IBUPROFEN
Oral Suspension 100 mg/5 mL

Pkg: Precision Dose, Inc. S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - ibuprofen 01

Principal Display Panel - 5 Ml Syringe Label

NDC# 68094-494-58

Children's IBUPROFEN Oral Suspension, 100 mg/5 mL

Delivers 5 mL (NSAID) For Hospital Use Only
Each 5 mL contains: sodium 2 mg
Alcohol Free
Gluten Free
Store at 20°-25°C (68°-77°F) Protect from freezing
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY495 Rev. 04/11

For Oral Use Only

Principal Display Panel - 5 mL Syringe Label - ibuprofen 02