CHILDRENS IBUPROFEN- ibuprofen suspension 
Pharmaceutical Associates, Inc.

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Children's Ibuprofen

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID) 1


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/Fever reducer

Uses

temporarily:

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

Dosing Chart
Weight (lb)Age (yr)Dose (mL)
**or as directed by a doctor
Under 24 lbsunder 2 yearsask a doctor
24–35 lbs2–3 years5 mL
36–47 lbs4–5 years7.5 mL
48–59 lbs6–8 years10 mL
60–71 lbs9–10 years12.5 mL
72–95 lbs11 years15 mL

Other information

Children's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form:

NDC 0121-1836-05:5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum.

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Gluten Free

DISTRIBUTED BY

MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PACKAGED BY

Pharmaceutical
Associates, Inc.

Greenville, SC 29605
www.paipharm.com

R12/17

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL
NDC 0121-1836-05

CHILDREN'S IBUPROFEN
O RAL  SUSPENSION
(NSAID)

100 mg per 5 mL (teaspoon)

SHAKE WELL

Alcohol Free

FOR INSTITUTIONAL USE ONLY

Pkg. by: Pharmaceutical Associates, Inc.
Greenville, SC 29605

SEE INSERT

A18360502

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
CHILDRENS IBUPROFEN 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1836(NDC:0904-5309)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1836-0510 in 1 CASE12/01/2014
110 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493712/01/2014
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693repack(0121-1836)

Revised: 2/2018
Document Id: 648ca080-bdbd-7f71-e053-2991aa0acbe2
Set id: d7fc559e-8cd3-4f31-9a89-150ad97eb890
Version: 6
Effective Time: 20180206
 
Pharmaceutical Associates, Inc.