Ibuprofen

Ibuprofen
SPL v5
SPL
SPL Set ID bc816597-a85a-4143-9f99-bb0699ca57c5
Route
ORAL
Published
Effective Date 2023-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (50 mg)
Inactive Ingredients
Caramel Sorbitol Solution Anhydrous Citric Acid Glycerin Polysorbate 80 Sodium Benzoate Sucrose Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2023-08-08

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Section 42229-5

Drug Facts

Section 50565-1

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)

Purposes

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • mL = milliliter
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child's mouth, toward the inner cheek
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day
Dosing Chart
Weight (lb) Age (mos) Dose (mL)
under 6 mos ask a doctor
12-17 lbs 6-11 mos 1.25 mL
18-23 lbs 12-23 mos 1.875 mL
Do Not Use
  • if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
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.

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing
  • see bottom panel of carton for lot number and expiration date
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.

Inactive Ingredients

berry flavor natural & artificial, caramel, citric acid (anhydrous), glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments?

Call 1-866-923-4914

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

Active Ingredient (in Each 1.25 Ml)

Ibuprofen 50 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 30 Ml Bottle Carton

*Compare to the active

ingredient in

Motrin ®Infants' Drops

NDC 51672-2146-3

For Ages 6 Mos. to 23 Mos.

Concentrated

Infants' Drops

Ibuprofen

Oral Suspension (NSAID)

50 mg per 1.25 mL

Pain reliever / Fever reducer

Dye-Free

Alcohol Free

Use only with

enclosed

syringe.

Lasts

up to

8 hours

Berry Flavor

1 FL OZ (30 mL)

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

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Purposes

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • mL = milliliter
  • measure with the dosing device provided. Do not use with any other device.
  • dispense liquid slowly into the child's mouth, toward the inner cheek
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day
Dosing Chart
Weight (lb) Age (mos) Dose (mL)
under 6 mos ask a doctor
12-17 lbs 6-11 mos 1.25 mL
18-23 lbs 12-23 mos 1.875 mL
Do Not Use (Do not use)
  • if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert (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.

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing
  • see bottom panel of carton for lot number and expiration date
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

berry flavor natural & artificial, caramel, citric acid (anhydrous), glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-866-923-4914

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
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
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
Heart Attack and Stroke Warning (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.

Active Ingredient (in Each 1.25 Ml) (Active ingredient (in each 1.25 mL))

Ibuprofen 50 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

*Compare to the active

ingredient in

Motrin ®Infants' Drops

NDC 51672-2146-3

For Ages 6 Mos. to 23 Mos.

Concentrated

Infants' Drops

Ibuprofen

Oral Suspension (NSAID)

50 mg per 1.25 mL

Pain reliever / Fever reducer

Dye-Free

Alcohol Free

Use only with

enclosed

syringe.

Lasts

up to

8 hours

Berry Flavor

1 FL OZ (30 mL)

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)