CHILDRENS IBUPROFEN 572- ibuprofen suspension/ drops

Childrens Ibuprofen 572 by

Drug Labeling and Warnings

Childrens Ibuprofen 572 by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (in each 5 mL)

Ibuprofen, USP 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

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
• asthma (wheezing)
• skin reddening
• facial swelling
• shock
• 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

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

• 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 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 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 20-25oC (68-77oF)
• do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

INACTIVE INGREDIENTS

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum.

QUESTIONS OR COMMENTS?

Call 1-609-860-2600 (Monday-Friday 8 am -4 pm)

PRINCIPAL DISPLAY PANEL

FAMILY Wellness

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN®*
Children's Ibuprofen

Oral Suspension

Ages 2 to 11 Years

USP 100 mg per 5 mL

Pain Reliever/Fever Reducer

(NSAID)

8 Hour

Alcohol Free

BUBBLE GUM FLAVOR

4 FL OZ (120mL)

  

 

INGREDIENTS AND APPEARANCE

CHILDRENS IBUPROFEN 572 
ibuprofen suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-929
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-929-03	1 in 1 CARTON	04/18/2024
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210149	04/18/2024

Labeler - Family Dollar Services, Inc. (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(55319-929)