IBUPROFEN ORAL - ibuprofen oral suspension 
Camber Consumer Care 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:

WARNINGS


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

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:


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

ASK A DOCTOR BEFORE USE IF



Ask a doctor or pharmacist before use if the child is

WHEN USING THIS PRODUCT


Stop use and ask a doctor if

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

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

PRINCIPAL DISPLAY PANEL

Ibuprofen oral suspension berry flavor with dye container carton

original berry flavour


Ibuprofen oral suspension berry flavor with dye free container carton

original berry flavour with dye free


Ibuprofen oral suspension grape flavor container carton

grape flavour


Ibuprofen oral suspension bubble gum flavor container carton

bubble gum flavour


IBUPROFEN ORAL  
ibuprofen oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (UNII: K679OBS311)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CELLULOSE, MICROCRYSTALLINE (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:69230-308-111 in 1 CARTON11/23/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060211/23/2018
IBUPROFEN ORAL  
ibuprofen oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-309
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 (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-309-111 in 1 CARTON09/18/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-309-121 in 1 CARTON09/18/2019
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060209/18/2019
IBUPROFEN ORAL  
ibuprofen oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-310
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 (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-310-111 in 1 CARTON09/18/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-310-121 in 1 CARTON09/18/2019
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060209/18/2019
IBUPROFEN ORAL  
ibuprofen oral suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-311
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 (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (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
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-311-111 in 1 CARTON09/18/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69230-311-121 in 1 CARTON09/18/2019
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060209/18/2019
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(69230-308, 69230-309, 69230-310, 69230-311)

Revised: 1/2022
Document Id: d5da8441-4fbc-aafb-e053-2995a90a5b42
Set id: b2dd4863-613e-4a41-98c1-3191e41b8463
Version: 3
Effective Time: 20220118
 
Camber Consumer Care Inc