IBUPROFEN CHILDRENS- ibuprofen suspension

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Meijer Distribution Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily:
Authorization status:
Abbreviated New Drug Application
Authorization number:
41250-897-26, 41250-897-28, 41250-897-34

IBUPROFEN CHILDRENS- ibuprofen suspension

Meijer Distribution Inc

----------

Meijer Distribution, Inc. Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever/fever reducer

Us es

temporarily:

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

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:

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,

relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

reduces fever

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

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

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

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)

if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer

right before or after heart surgery

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

under a doctor’s care for any serious condition

taking any other drug

give with food or milk if stomach upset occurs

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

Directions

Dosing Chart

Weight (lb)

Age (yr)

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

Inactive ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high

fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution,

xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Motrin® active ingredient

For Ages 2 to 11 Years

CHILDREN’S

ibuprofen

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

wash dosage cup after each use

each 5 mL contains: sodium 2 mg

do not use if printed neckband is broken or missing

store at 20-25 C (68-77 F)

do not freeze

Oral Suspension 100 mg Per 5 mL

Pain Reliever

Fever Reducer (NSAID)

Lasts up to 8 HOURS

Berry Flavor

Alcohol Free

4 FL OZ (120 mL)

IBUPROFEN CHILDRENS

ibuprofen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -8 9 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

10 0 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

ORANGE

S core

S hap e

S iz e

Flavor

BERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -8 9 7-26

1 in 1 CARTON

0 1/0 5/19 9 9

1

120 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:41250 -8 9 7-34

1 in 1 CARTON

0 1/0 7/20 0 4

2

240 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:41250 -8 9 7-28

1 in 1 CARTON

0 4/26 /20 13

0 5/0 1/20 15

3

150 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Meijer Distribution Inc

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 749 37

0 1/0 5/19 9 9

Labeler -

Meijer Distribution Inc (006959555)

Revised: 5/2019

Similar products

Search alerts related to this product

View documents history

Share this information