Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (otc)

Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (otc)
SPL v3
SPL
SPL Set ID b2dd4863-613e-4a41-98c1-3191e41b8463
Route
ORAL
Published
Effective Date 2022-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
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 Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Pill Appearance
Color: orange Color: purple Color: pink
Marketing Status
ANDA Active Since 2019-09-18

Description

(in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer





Description

(in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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.

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 

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
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
Questions Section


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

Monday-Friday.           











Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA

Active Ingredient(s)

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug



Principal Display Panel

Ibuprofen oral suspension berry flavor with dye container carton





Ibuprofen oral suspension berry flavor with dye free container carton





Ibuprofen oral suspension grape flavor container carton





Ibuprofen oral suspension bubble gum flavor container carton





When Using This Product
  • take with food or milk if stomach upset occurs


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




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.

 

 

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)

Ask A Doctor Or Pharmacist Before Use If the Child Is
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Use(s) (USE(S))

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Purpose (PURPOSE)

Pain reliever/fever reducer





Warnings (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.

Directions (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 

Do Not Use (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
Other Information (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
Questions Section (QUESTIONS SECTION)


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

Monday-Friday.           











Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA

Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each 5 mL)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ibuprofen oral suspension berry flavor with dye container carton





Ibuprofen oral suspension berry flavor with dye free container carton





Ibuprofen oral suspension grape flavor container carton





Ibuprofen oral suspension bubble gum flavor container carton





When Using This Product (WHEN USING THIS PRODUCT)
  • take with food or milk if stomach upset occurs


Ask A Doctor Before Use If (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




Inactive Ingredient Section (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.

 

 

Stop Use and Ask A Doctor If (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 (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)

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)