IBUPROFEN ORAL- ibuprofen oral suspension 
Preferred Pharmaceuticals Inc.

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Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)

ACTIVE INGREDIENT(S)

(in each 5 mL)
Ibuprofen 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
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 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 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)
under 24
24-35 lbs
36-47 lbs
48-59 lbs
60-71 lbs
72-95 lbs 


 Age (yr)

under 2 years
2-3 years
4-5 years
6-8 years
9-10 years
11 years


 Dose (mL)*

ask  a doctor
5 mL
7.5 mL
10 mL
12.5 mL
15 mL

*or as directed by a doctor 

Other information

 each 5 mL contains : sodium 2 mg
 store between 20-25°C (68-77°F)
 do not use if carton is opened or printed bottle neckband is broken or missing
 see bottom panel for lot number and expiration date

INACTIVE INGREDIENT SECTION

Berry flavor (with dye)

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

Berry flavor (dye free)

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

Grape flavor

 

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Blue #1, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

Bubble Gum flavor

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

 

 

QUESTIONS SECTION

Call 1-888-588-1418 from 9 AM to 5 PM EST,
Monday-Friday.           

ibuprofencamberlogo

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

Ibuprofen oral suspension berry flavor with dye container carton

Childrens Ibuprofen Oral Suspension
IBUPROFEN ORAL 
ibuprofen oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7984(NDC:69230-308)
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (1.3 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) (UNII: 72QQR5RYU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7984-11 in 1 CARTON08/05/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060208/05/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7984)

Revised: 3/2024
Document Id: 8db8b121-ef9c-4c36-a25d-3e8fc1e0ea78
Set id: 8ccce5d5-a3fa-454f-b193-1222083b5680
Version: 4
Effective Time: 20240325
 
Preferred Pharmaceuticals Inc.