CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension 
Pharmaceutical Associates, Inc.

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Children's Ibuprofen Oral Suspension USP

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen 100 mg (NSAID)**…………………………………… Pain reliever/fever reducer
**nonsteroidal anti-inflammatory drug

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

  • take 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 (1-800-222-1222) right away.

Directions

Dosing Chart
Weight (lb)Age (yr)Dose (mL)*
under 24under 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

*or as directed by a doctor

Other information

Children's Ibuprofen Oral Suspension is purple, grape flavored suspension supplied in the following oral dosage forms:

NDC 0121-0914-05: 5 mL unit dose cup
NDC 0121-0914-00: Case contains 100 unit dose cups of 5 mL (0121-0914-05), packaged in 10 trays of 10 unit dose cups each
NDC 0121-1828-10: 10 mL unit dose cup
NDC 0121-1828-00: Case contains 100 unit dose cups of 10 mL (0121-1828-10) packaged in 10 trays of 10 unit dose cups each

Inactive ingredients

acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum.

Questions or comments?

Call 1-800-845-8210.

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, distributor of Children’s Motrin®

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0914-05

Children's Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain reliever/Fever reducer

Grape Flavored/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

Principal Display Panel

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1828-10

Children's Ibuprofen Oral Suspension, USP

(NSAID)

200 mg per 10 mL

Pain reliever/Fever reducer

Grape Flavored/Alcohol Free

SHAKE WELL

Package Not Child-Resistant

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

Principal Display Panel

CHILDRENS IBUPROFEN ORAL SUSPENSION 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0914
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
WATER (UNII: 059QF0KO0R)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0914-0010 in 1 CASE06/18/2020
110 in 1 TRAY
1NDC:0121-0914-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491604/30/1999
CHILDRENS IBUPROFEN ORAL SUSPENSION 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1828
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-1828-0010 in 1 CASE06/18/2020
110 in 1 TRAY
1NDC:0121-1828-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07491604/30/1999
Labeler - Pharmaceutical Associates, Inc. (044940096)
Registrant - Pharmaceutical Associates, Inc. (097630693)
Establishment
NameAddressID/FEIBusiness Operations
G&W Industries, Inc.079419931manufacture(0121-0914, 0121-1828)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693label(0121-0914, 0121-1828)

Revised: 8/2022
Document Id: e78c2544-9dfe-6399-e053-2995a90ac3d0
Set id: 7a6832f2-2d80-483c-bde3-e6cacb7c318a
Version: 5
Effective Time: 20220831
 
Pharmaceutical Associates, Inc.