Infants Ibuprofen: Package Insert and Label Information

INFANTS IBUPROFEN- ibuprofen suspension
Proficient Rx LP

Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug


Pain reliever/Fever reducer



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


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

facial swelling
asthma (wheezing)
skin reddening

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 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

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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).


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 below. If possible, use weight to dose; otherwise use age.
mL = milliliter
measure with the dosing device provided. Do not use with any other device.
dispense liquid slowly into the child’s mouth, toward the inner cheek
if needed, repeat dose every 6 to 8 hours
do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12 to 17 lbs

6 to 11 mos

1.25 mL

18 to 23 lbs

12 to 23 mos

1.875 mL

Other information

store between 20° to 25°C (68° to 77°F)
do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions or Comments?

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

Principal Display Panel


Compare to the active ingredient in Concentrated Motrin® Infants’ Drops

NDC 71205-110-30

See New Warnings

For Ages 6 Mos. to 23 Mos.

Infants’ Ibuprofen

Concentrated Ibuprofen Oral Suspension, USP


50 mg per 1.25 mL

Pain Reliever

Fever Reducer

Lasts up to 8 hours


Use only with enclosed syringe

Dye-Free Berry Flavor

Alcohol Free

½ FL OZ (15 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

(click image for full-size original)
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-110(NDC:45963-125)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor BERRY Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:71205-110-15 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (71205-110-15)
2 NDC:71205-110-30 1 BOTTLE in 1 CARTON contains a BOTTLE
2 30 mL in 1 BOTTLE This package is contained within the CARTON (71205-110-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079058 05/11/2010
Labeler — Proficient Rx LP (079196022)
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (71205-110)

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