GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN- ibuprofen tablet, chewable

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Amerisource Bergen
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily:
Authorization status:
Abbreviated New Drug Application
Authorization number:
46122-617-62

GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN- ibuprofen tablet, chewable

Amerisource Bergen

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Amerisource Bergen Children’s Ibuprofen Drug Facts

Active ingredient (in each chewable tablet)

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,

reduces fever

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

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

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

take 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)

Tablets

under 24

under 2

ask a doctor

24-35

36-47

1 ½

48-59

60-71

9-10

2 ½

72-95

Other information

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

Principal Display Panel

Compare to Children’s Motrin® active ingredient

FOR AGES 2 TO 11

children’s

Ibuprofen

chewable tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Chewables

chew or crush tablets completely before swallowing

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

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

24 orange-flavored chewable tablets

GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN

ibuprofen tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-6 17

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

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

ASPARTAME (UNII: Z0 H242BBR1)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO YBEAN O IL (UNII: 241ATL177A)

SUCCINIC ACID (UNII: AB6 MNQ6 J6 L)

Product Characteristics

Color

ORANGE

S core

2 pieces

S hap e

ROUND

S iz e

13mm

Flavor

ORANGE

Imprint Code

L46 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-6 17-6 2

1 in 1 CARTON

0 7/31/20 19

1

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 359

0 7/31/20 19

Amerisource Bergen

Labeler -

Amerisource Bergen (007914906)

Revised: 7/2019

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