Topcare Childrens Ibuprofen: Package Insert and Label Information

TOPCARE CHILDRENS IBUPROFEN- ibuprofen suspension
Topco Associates LLC

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

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 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

give 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

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

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

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

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial grape flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO CHILDREN’S MOTRIN® GRAPE FLAVOR ACTIVE INGREDIENT

SEE NEW WARNINGS

children’s

Ibuprofen

ORAL SUSPENSION

100 mg per 5 mL

PAIN RELIEVER — FEVER REDUCER (NSAID)

Lasts up to 8 HOURS

OUR PHARMACISTS RECOMMEND

Alcohol Free

Ages 2 to 11 Years

GRAPE FLAVOR

4 FL OZ (120 mL)

Children's Ibuprofen Carton
(click image for full-size original)
TOPCARE CHILDRENS IBUPROFEN
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-660
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
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
HYPROMELLOSE, UNSPECIFIED
POLYSORBATE 80
WATER
SODIUM BENZOATE
SORBITOL
XANTHAN GUM
Product Characteristics
Color PURPLE (opaque) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-660-26 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (36800-660-26)
2 NDC:36800-660-28 1 BOTTLE in 1 CARTON contains a BOTTLE
2 148 mL in 1 BOTTLE This package is contained within the CARTON (36800-660-28)
3 NDC:36800-660-00 1 BOTTLE in 1 CARTON contains a BOTTLE
3 120 mL in 1 BOTTLE This package is contained within the CARTON (36800-660-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074937 07/02/2002
Labeler — Topco Associates LLC (006935977)

Revised: 11/2021 Topco Associates LLC

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 © 2021. All Rights Reserved.