Childrens Ibuprofen 100: Package Insert and Label Information

CHILDRENS IBUPROFEN 100- ibuprofen tablet, chewable
Walgreen Company

Active ingredient (in each chewable tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

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)
do not use if printed seal under cap is broken or missing

Inactive ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

children’s Ibuprofen 100

Compare to Children’s Motrin® active ingredient

IBUPROFEN CHEWABLE TABLETS 100 mg PAIN RELIEVER / FEVER REDUCER (NSAID)

CHEWABLES

ORANGE FLAVOR

LASTS UP TO 8 HOURS

Chew or crush tablets completely before swallowing

NOT ACTUAL SIZE

AGES 2 TO 11 YEARS

24 CHEWABLE TABLETS

childreens ibuprofen 100 image
(click image for full-size original)
CHILDRENS IBUPROFEN 100
ibuprofen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
AMMONIUM GLYCYRRHIZATE
ASPARTAME
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SOYBEAN OIL
SUCCINIC ACID
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 13mm
Flavor ORANGE Imprint Code L461
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1461-62 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (0363-1461-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076359 06/06/2019
Labeler — Walgreen Company (008965063)

Revised: 11/2019 Walgreen Company

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.