CHILDRENS IBUPROFEN- ibuprofen suspension

Childrens Ibuprofen by

Drug Labeling and Warnings

Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

INGREDIENTS AND APPEARANCE

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)