CHILDRENS MOTRIN- ibuprofen tablet, chewable

Childrens Motrin by

Drug Labeling and Warnings

Childrens Motrin by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each chewable tablet)

Ibuprofen 100 mg (NSAID)1

1 nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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

mouth or throat burning may occur; give with food or water
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

chew or crush tablets completely before swallowing
this product does not contain directions or complete warnings for adult use
do not give more than directed
find right dose on chart below. 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)	Tablets
under 24	under 2	ask a doctor
24-35	2-3	1
36-47	4-5	1 ½
48-59	6-8	2
60-71	9-10	2 ½
72-95	11	3

Other information

phenylketonurics: contains phenylalanine 6 mg per tablet
store between 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

PRINCIPAL DISPLAY PANEL

Children's
Motrin®

NDC: 50580-933-01

For Ages 2 to 11 Years

Lasts up to
8 hours

Ibuprofen Chewable Tablets,100 mg
Pain Reliever / Fever Reducer (NSAID)
Chewables

Actual Size

24
Grape-Flavored
Chewable Tablets

Chew or crush tablets
completely before swallowing

INGREDIENTS AND APPEARANCE

CHILDRENS MOTRIN
ibuprofen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-933
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	100 mg

Ingredient Name	Strength
Inactive Ingredients
acesulfame potassium (UNII: 23OV73Q5G9)
ammonium glycyrrhizate (UNII: 3VRD35U26C)
aspartame (UNII: Z0H242BBR1)
carnauba wax (UNII: R12CBM0EIZ)
croscarmellose sodium (UNII: M28OL1HH48)
D&C red no. 27 aluminum lake (UNII: ZK64F7XSTX)
FD&C blue no. 1--aluminum lake (UNII: J9EQA3S2JM)
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium lauryl sulfate (UNII: 368GB5141J)
soybean oil (UNII: 241ATL177A)
succinic acid (UNII: AB6MNQ6J6L)

Product Characteristics
Color	PURPLE (lavender)	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor	GRAPE	Imprint Code	M;100
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 50580-933-01	1 in 1 CARTON	06/17/2019
1		24 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	ANDA076359	06/17/2019

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)