FDA Label for Childrens Ibuprofen

Other

Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin ^® Dye-Free Berry Flavor.

DO NOT USE IF SEAL IS BROKEN.

Distributed by:
American Health Packaging
Columbus, OH 43217

R07/23

Active Ingredient (In Each 5 Ml Cup)

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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
    
    

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.
• 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	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL (1 unit dose cup)
36-47 lbs	4-5 years	7.5 mL (1.5 unit dose cups)
48-59 lbs	6-8 years	10 mL (2 unit dose cups)
60-71 lbs	9-10 years	12.5 mL (2.5 unit dose cups)
72-95 lbs	11 years	15 mL (3 unit dose cups)

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 a clear, berry flavored suspension supplied in the following oral dosage forms:
5 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐743‐17

Inactive Ingredients:

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Questions Or Comments?

Call 1-800-845-8210.

Principal Display Panel – Tray Label

Case NDC 60687-743-17/Cup NDC 60687-743-40

Children’s Ibuprofen
Oral Suspension, USP
(NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T1022C050723            R07/23

Principal Display Panel – Cup - 100 Mg / 5 Ml

NDC 60687- 743-40

Children's Ibuprofen
Oral Suspension, USP
(NSAID)
Pain Reliever/Fever Reducer

100 mg per 5 ml

Berry Flavored/Dye Free/ Alcohol Free

Delivers 5 mL

SHAKE WELL

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

A1022C05/1023