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

Ibuprofen Oral by

Drug Labeling and Warnings

Ibuprofen Oral by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IBUPROFEN ORAL- ibuprofen oral suspension 
Bryant Ranch Prepack

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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

HOW SUPPLIED

NDC: 63629-1230-1: 118 mL Suspension in a BOTTLE

Ibuprofen 100 mg/5ml Suspension #118

Label
IBUPROFEN ORAL 
ibuprofen oral suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 63629-1230(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, UNSPECIFIED (UNII: K679OBS311)  
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: 63629-1230-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060211/23/201804/29/2021
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1230) , RELABEL(63629-1230)

Revised: 4/2021
 

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