CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Discount Drug Mart
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 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 Slop 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
53943-119-24

CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension

Discount Drug Mart

----------

Children's Ibuprofen Oral Suspension

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)

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

NSAlD, 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 lor a longer time than directed

Heart attack and stroke warning: NSAlDs, 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 lor longer than directed.

Sore throat warning: Severe or persistent sore throat or

sore throat accompanied by high lever, 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

heartbum

■ 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 lor any serious condition

■ taking any other drug

When using this product

■ take with food or milk if stomach upset occurs

Slop 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

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

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

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

*or as dIrected by a doctor

Other information

each 5 mL contains: sodium 2 mg

■ store between 20-25° C (68-77° F)

do not use if carton is opened or printed bottle

neckband is broken or missing

■ see bottom panel for lot number and expiration date

Inactive ingredients

Acesullame potassium, anhydrous citric acid,

carboxymethylcellulose sodium, D&C Yellow #10, FD&C

Red #40, flavors, glycerin, microcrystalline cellulose,

polysorbate 80, propylene glycol, purified water, sodium

benzoate, sucrose, and xanthan gum

Questions or comments?

Call 1-877-798-5944 from 9:30 AM to 4:30 PM EST,

Monday-Friday.

Package Labeling

For Ages 2 to 11 Years

DISCOUNT

drug

mart

FOOD FAIR

Children's

Ibuprofen

Oral Suspension (NSAID)

100 mg per 5mL

DISCOUNT

drug

mart

FOOD FAIR

NDC 53943-119-24

Compare To The

Active Ingredient In

Children's Motrin® **

SEE NEW WARNINGS

For Ages 2 to 11 Years

Children's

Ibuprofen

Oral Suspension (NSAID)

100 mg per 5mL

Pain Reliever/Fever reducer

LASTS UP TO 8 HOURS

ALCOHOL FREE

Original Berry Flavor

4 FL OZ (118 mL)

Important: Read all product information before using.

Keep this box for important information.

This product is intended for use in children.

**This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Motrin .

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND

PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO

RETURN TO STORE, SEND REASON FOR DISSATISFACTION,

NAME, ADDRESS, AND EMPTY PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

BX-082

0 93351 02962 2

01078436

Box Label

®

Bottle Label

CHILDRENS IBUPROFEN ORAL SUSPENSION

ibuprofen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:539 43-119

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

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SUCRO SE (UNII: C151H8 M554)

XANTHAN GUM (UNII: TTV12P4NEE)

Discount Drug Mart

Product Characteristics

Color

o ra nge

S core

S hap e

S iz e

Flavor

BERRY (Original)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:539 43-119 -24

1 in 1 CARTON

0 8 /16 /20 19

1

118 mL 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

ANDA210 6 0 2

0 8 /16 /20 19

Labeler -

Discount Drug Mart (047741335)

Registrant -

AptaPharma Inc. (790523323)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AptaPharma Inc.

79 0 523323

ma nufa c ture (539 43-119 )

Revised: 8/2019

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