Ibuprofen Oral Suspension, Usp

Ibuprofen Oral Suspension, Usp
SPL v4
SPL
SPL Set ID 3bbbe142-a00c-404b-a116-81ad730ea130
Route
ORAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Completed Since 2020-12-04 Until 2027-03-01

Description

Ibuprofen 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Ibuprofen 50 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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
  • 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 to 17 lbs 6 to 11 mos  1.25 mL
18 to 23 lbs 12 to 23 mos 1.875 mL 
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
Package Label
WALGREENS Infants ibuprofen Berry Flavor
Other Information
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Concentrated Motrin® Infants' Drops††

infants'

Ibuprofen

CONCENTRATED IBUPROFEN

ORAL SUSPENSION, USP (NSAID)

50 mg PER 1.25 mL

PAIN RELIEVER / FEVER REDUCER

Alcohol Free

Dye-Free

Non-staining

  • Lasts up to 8 hours

AGES 6 -23 MONTHS

BERRY FLAVOR

Use only with enclosed syringe

FL OZ (mL)

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS BOX FOR IMPORTANT INFORMATION. THIS PRODUCT IS INTENDED FOR USE IN CHILDREN AGES 6 MONTHS TO 23 MONTHS OF AGE.

††This product is not affiliated with, manufactured by, or produced by the makers or owners of Motrin®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

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
Stop Use and Ask A Doctor If
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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  (1-800-222-1222) right away

Active Ingredient (in Each 1.25 Ml)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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
Purpose

Pain reliever/Fever reducer

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
  • 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 to 17 lbs 6 to 11 mos  1.25 mL
18 to 23 lbs 12 to 23 mos 1.875 mL 
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
Package Label (Package label)
WALGREENS Infants ibuprofen Berry Flavor
Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Questions Or Comments? (Questions or Comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (Principal display panel)

Compare to the active ingredient in Concentrated Motrin® Infants' Drops††

infants'

Ibuprofen

CONCENTRATED IBUPROFEN

ORAL SUSPENSION, USP (NSAID)

50 mg PER 1.25 mL

PAIN RELIEVER / FEVER REDUCER

Alcohol Free

Dye-Free

Non-staining

  • Lasts up to 8 hours

AGES 6 -23 MONTHS

BERRY FLAVOR

Use only with enclosed syringe

FL OZ (mL)

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS BOX FOR IMPORTANT INFORMATION. THIS PRODUCT IS INTENDED FOR USE IN CHILDREN AGES 6 MONTHS TO 23 MONTHS OF AGE.

††This product is not affiliated with, manufactured by, or produced by the makers or owners of Motrin®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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  (1-800-222-1222) right away

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

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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)