CHILDRENS FLANAX ORAL- ibuprofen suspension

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. 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 to 8 hours
do not use more than 4 times a day
replace original bottle cap to maintain child resistance
wash dosage cup after each use

Dosing Chart
Weight (lb)	Age (year)	Dose (mL)*
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

* 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 carton is opened or seal under cap opening is broken or missing see bottom panel for lot number and expiration date
Inactive ingredients

Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum
Questions or comments?

1-888-779-2877
9AM-5PM EST Mon-Fri.
SPL UNCLASSIFIED SECTION

LASTS UP TO 8 HOURS

for kids

Berry Flavor
Alcohol Free

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

KEEP IN OUTER CARTON UNTIL CONTENTS USED

Distributed by: Belmora LLC,
3033 Wilson Blvd., Suite 700, Arlington, VA 22201
Made in India

Code: AP/DRUGS/04/2016
Packaging

INGREDIENTS AND APPEARANCE

CHILDRENS FLANAX ORAL
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-777
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
CHERRY (UNII: BUC5I9595W)
STRAWBERRY (UNII: 4J2TY8Y81V)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, POTATO (UNII: 8I089SAH3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 27854-777-99	1 in 1 CARTON	01/26/2024
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209179	01/26/2024

Labeler - Belmora LLC (112753244)

CHILDRENS FLANAX ORAL- ibuprofen suspension

Childrens FLANAX ORAL by

Drug Labeling and Warnings

Drug Details [pdf]