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Childrens Ibuprofen by Proficient Rx LP

Medically reviewed on September 1, 2017

Dosage form: suspension
Ingredients: IBUPROFEN 100mg in 5mL
Labeler: Proficient Rx LP
NDC Code: 63187-166

Children’s Ibuprofen Oral Suspension, USP

ACTIVE INGREDIENT

(in each 5 mL = 1 teaspoon)

Ibuprofen, USP 100 mg (NSAID)**

**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
shock
asthma (wheezing)
rash
skin reddening
blisters
facial swelling

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

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 any other pain reliever/fever reducer
right before or after heart surgery

ASK 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, or kidney disease
child has asthma
child is taking a diuretic

ASK 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
take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
the child does not get any relief within the 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
find right dose on chart.  If possible, use weight to dose; otherwise use age.
use only enclosed measuring cup
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 (tsp or mL)

under 2 years

ask a doctor

24 – 35 lbs

2 – 3 years

1 tsp or 5 mL

36 – 47 lbs

4 – 5 years

1½ tsp or 7.5 mL

48 – 59 lbs

6 – 8 years

2 tsp or 10 mL

60 – 71 lbs

9 – 10 years

2½ tsp or 12.5 mL

72 – 95 lbs

11 years

3 tsp or 15 mL

Other information

each teaspoon contains: sodium 2 mg
do not use if printed neckband is broken or missing
store between 20 - 25°C (68 - 77°F)
see bottom panel for lot number and expiration date

INACTIVE INGREDIENT

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children’s Motrin( Bubble Gum*

NDC 63187-166-18

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

Pain Reliever

Fever Reducer

Lasts up to 8 hours

Bubble Gum Flavor

Alcohol Free

4 FL OZ (118 mL)

12630112F1 VC100162

CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-166(NDC:0472-1263)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPINK (light) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-166-18118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491606/01/2006
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-166), REPACK(63187-166)

 
Proficient Rx LP

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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