Childrens Ibuprofen Oral Suspension: Package Insert and Label Information

CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension
AptaPharma Inc.

Drug Facts

Active ingredient
(in each 5 mL)

Ibuprofen 100 mg*
*nonsteroidal anti-inflammatory drug

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 for 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 for 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 20-2S° C (68-77° F)
■ do not use if carton is opened or printad 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 weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944

Package Labeling

New Warnings NDC 76281-119-24

Compare To The
Active Ingredient In
Children’s Motrin ^® **

Children’s

Ibuprofen

Oral Suspension (NSAID)

100 mg per 5 mL

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 infomation.
This product is intended for use in children.

**This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children’s Motrin ^®.

Manufacrured by:
APTAPHARMA Inc.
1533 Union Avenue Pennsauken, NJ 08110, USA

BX-065

res

CHILDRENS IBUPROFEN ORAL SUSPENSION ibuprofen suspension

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-119 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM

Product Characteristics Color orange Score Shape Size Flavor BERRY (Original) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76281-119-24 1 BOTTLE in 1 CARTON contains a BOTTLE 1 118 mL in 1 BOTTLE This package is contained within the CARTON (76281-119-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 09/30/2020

Labeler — AptaPharma Inc. (790523323)

Registrant — AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Operations
AptaPharma Inc.		790523323	manufacture (76281-119)

Revised: 11/2022 AptaPharma Inc.