CHILDRENS IBUPROFEN- ibuprofen suspension

Childrens Ibuprofen by

Drug Labeling and Warnings

Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by FAMILY WELLNESS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)1

1 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 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 get 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

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
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

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing
see bottom panel of carton for lot number and expiration date

Inactive ingredients

acesulfame potassium, berry flavor natural & artificial, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sucrose, xanthan gum

Questions?

1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

COMPARED TO THE ACTIVE INGREDIENT
IN CHILDREN MOTRIN®* DYE-FREE BERRY FLAVOR*

FAMILY
wellness™

See New Warnings
NDC: 55319-150-08

For Ages 2 to 11 Years

Children's
Ibuprofen

Oral Suspension, USP
100 mg per 5 mL

Pain Reliever/Fever Reducer
(NSAID)

8
Lasts up to
HOURS

Berry
Flavor

Dye-Free, Alcohol Free

100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED

4 fl oz (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-150
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)
glycerin (UNII: PDC6A3C0OX)
polysorbate 80 (UNII: 6OZP39ZG8H)
sodium benzoate (UNII: OJ245FE5EU)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE to OFF-WHITE)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 55319-150-08	1 in 1 CARTON	03/05/2019
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	ANDA209207	06/27/2017

Labeler - FAMILY WELLNESS (024472631)