Ibuprofen Oral Suspension, USP

Drug Labeling and Warnings

Drug Details [pdf]

PEDIACARE INFANTS- ibuprofen liquid 
Medtech Products Inc.

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Ibuprofen Oral Suspension, USP

Drug Facts

Active ingredient

(in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

Purpose

Pain reliever/Fever reducer

* nonsteroidal anti-inflammatory drug

Uses

temporarily:

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

Warnings

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

Symptoms may include:

• hives
  
• facial swelling
  
• shock
  
• rash
  
• asthma (wheezing)
  
• skin reddening
  
• 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 the 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 a doctor before use if

• stomach bleeding warning applies to your child
  
• child has a history of stomach problems, such as heartburn
  
• 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 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 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
  
• 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
  
• find right does on chart below. If possible, use weight to dose; otherwise use age.
  
• 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 20º to 25ºC (68º to 77ºF)
  
• do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing
  
• see bottom panel for lot number and expiration date

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?

call 1-888-474-3099 Monday through Friday 8AM to 8PM EST or visit us at www.PediaCare.com

Principal Display Panel

NEW! INFANTS 6-23 months
PediaCare® we care for kidsTM
PAIN RELIEVER
FEVER REDUCER
IB Ibuprofen
Concentrated Oral Suspension, USP
(NSAID) 50 mg/ 1.25mL
Alcohol Free
Dye-Free Berry FLAVOR
Lasts up to 8 hours!
1 FL OZ (30 mL)

PEDIACARE INFANTS 
ibuprofen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-900
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	50 mg  in 1.25 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-900-01	1 in 1 CARTON	10/15/2011	11/30/2015
1		30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 63029-900-05	1 in 1 CARTON	10/15/2011	04/30/2016
2		15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079058	10/15/2011	04/30/2016

Labeler - Medtech Products Inc. (122715688)

Revised: 6/2019

Document Id: 93cd6b2e-a0bf-47f0-b4ea-d16837e8c734

34390-5

Set id: 8d904483-5a90-4271-b69f-b33c7e875245

Version: 7

Effective Time: 20190619