OTC Medication Information: Ibuprofen Oral

IBUPROFEN ORAL — ibuprofen suspension
Strategic Sourcing Services

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 833-358-6431 Mon — Fri 9 AM to 7 PM EST.
Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC., Memphis, TN 38141

PRINCIPAL DISPLAY PANEL

Ibuprofen oral suspension berry flavour with dye container carton

berry-4oz
(click image for full-size original)

Ibuprofen oral suspension berry flavour with dye free container carton

berry-dye-free
(click image for full-size original)

Ibuprofen oral suspension grape flavour container carton

grape
(click image for full-size original)

Ibuprofen oral suspension bubble gum flavour container carton

bubble-gum
(click image for full-size original)
IBUPROFEN ORAL ibuprofen oral suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
D&C YELLOW NO. 10
GLYCERIN
FD&C RED NO. 40
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color orange Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0150-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (70677-0150-1)
2 NDC:70677-0150-2 1 BOTTLE in 1 CARTON contains a BOTTLE
2 237 mL in 1 BOTTLE This package is contained within the CARTON (70677-0150-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210602 11/23/2018
IBUPROFEN ORAL ibuprofen oral suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0153
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
FD&C BLUE NO. 1
D&C RED NO. 33
Product Characteristics
Color purple Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0153-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (70677-0153-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210602 08/01/2022
IBUPROFEN ORAL ibuprofen oral suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0152
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
FD&C RED NO. 40
D&C RED NO. 33
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0152-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (70677-0152-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210602 08/01/2022
IBUPROFEN ORAL ibuprofen oral suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0151
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0151-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (70677-0151-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210602 08/01/2022
Labeler — Strategic Sourcing Services (116956644)
Establishment
Name Address ID/FEI Operations
AptaPharma Inc. 790523323 manufacture (70677-0150), manufacture (70677-0151), manufacture (70677-0152), manufacture (70677-0153)

Revised: 08/2022 Strategic Sourcing Services

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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