CHILDRENS IBUPROFEN- ibuprofen suspension 
A-S Medication Solutions

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Ibuprofen Oral Suspension, USP

Drug Facts

Active ingredient

(in each 5 mL)
Ibuprofen, USP 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.
• 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

Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

HOW SUPPLIED

Product: 50090-2528

NDC: 50090-2528-0 118 mL in a BOTTLE / 1 in a CARTON

Ibuprofen

Label Image
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2528(NDC:0472-1255)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Other Ingredients
Ingredient Kind Ingredient Name Quantity
Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-2528-0 1 in 1 CARTON 10/18/2016
1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 04/30/1999
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-2528)

Revised: 8/2018
Document Id: 95209ec8-5cc7-44f6-b6a0-f6c833e8bd01
Set id: bf33f790-c49f-488e-8480-39d13e308838
Version: 7
Effective Time: 20180823
 
A-S Medication Solutions