Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 5fddb815-3787-4484-8ac6-b5360f592ad0

Route

ORAL

Published

Effective Date 2024-06-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Ibuprofen (100 mg)

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid Fd&c Red No. 40 Glycerin D&c Red No. 33 Fd&c Blue No. 1 Water Sodium Benzoate Starch, Corn Polysorbate 80 Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-12-10

Description

Ibuprofen, USP 100 mg (NSAID)** **Nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen, USP 100 mg (NSAID)** **Nonsteroidal anti-inflammatory drug

Uses

temporarily

relieves minor aches and pains due to: 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 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 drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen naproxen, or others)
takes more or for 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 a 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 the 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)	Age (yr)	Dose (mL)*
under 24	under 2	ask a doctor
24-35	2-3	5 mL
36-47	4-5	7.5 ml
48-59	6-8	10 mL
60-71	9-10	12.5 mL
72-95	11	15 mL

*or as directed by a doctor

Do Not Use

if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
right before or after hear surgery

Product Label

WALGREENS Children's Ibuprofen Grape Flavor

Other Information

each 5 mL contains: sodium 2 mg
store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

acesulfame potassium, artifical grape flavor, citric acid anhydrous, FD&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purfied water, sodium benzoate, sucrose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

Compare to Children's Motrin® active ingredient††

FOR AGES 2 TO 11 YEARS

Children's

Ibuprofen 100

IBUPROFEN

ORAL SUSPENSION, USP (NSAID)

100 mg per 5 mL

PAIN RELIEVER / FEVER REDUCER

LAST UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

GRAPE FLAVOR

Shake well before using

Dosage Cup Included

FL OZ (mL)

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND 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 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
- vomit 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 (24hours) 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 5 Ml)

Ibuprofen, USP 100 mg (NSAID)**

**Nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If Your Child Is

under a doctor's care for any serious condition
taking any other drug

Structured Label Content

Uses

temporarily

relieves minor aches and pains due to: common cold,flu, sore throat, headache and toothache
reduces fever

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 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 drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen naproxen, or others)
takes more or for longer time than directed

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 the 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)	Age (yr)	Dose (mL)*
under 24	under 2	ask a doctor
24-35	2-3	5 mL
36-47	4-5	7.5 ml
48-59	6-8	10 mL
60-71	9-10	12.5 mL
72-95	11	15 mL

*or as directed by a doctor

Do Not Use (Do not use)

if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
right before or after hear surgery

Product Label

WALGREENS Children's Ibuprofen Grape Flavor

Other Information (Other information)

each 5 mL contains: sodium 2 mg
store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

Compare to Children's Motrin® active ingredient††

FOR AGES 2 TO 11 YEARS

Children's

Ibuprofen 100

IBUPROFEN

ORAL SUSPENSION, USP (NSAID)

100 mg per 5 mL

PAIN RELIEVER / FEVER REDUCER

LAST UP TO 8 HOURS

ALCOHOL FREE

AGES 2-11 YEARS

GRAPE FLAVOR

Shake well before using

Dosage Cup Included

FL OZ (mL)

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND 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 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
- vomit 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 (24hours) 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 5 Ml) (Active ingredient (in each 5 mL))

Ibuprofen, USP 100 mg (NSAID)**

**Nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

under a doctor's care for any serious condition
taking any other drug

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: common cold,flu, sore throat, headache and toothache reduces fever", "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 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 drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen naproxen, or others) takes more or for 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 a 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 the 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) Age (yr) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor", "Do not use": "if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after hear surgery", "Product Label": "WALGREENS Children's Ibuprofen Grape Flavor", "Other information": "each 5 mL contains : sodium 2 mg store between 20º to 25ºC (68º to 77ºF)", "Inactive ingredients": "acesulfame potassium, artifical grape flavor, citric acid anhydrous, FD&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purfied water, sodium benzoate, sucrose, xanthan gum", "Questions or Comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "Compare to Children's Motrin® active ingredient†† FOR AGES 2 TO 11 YEARS Children's Ibuprofen 100 IBUPROFEN ORAL SUSPENSION, USP ( NSAID) 100 mg per 5 mL PAIN RELIEVER / FEVER REDUCER LAST UP TO 8 HOURS ALCOHOL FREE AGES 2-11 YEARS GRAPE FLAVOR Shake well before using Dosage Cup Included FL OZ (mL) ††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Motrin®. TAMPER EVIDENT: DO NOT USE IF PRINTED NECKBAND 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 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 vomit 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 (24hours) 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 5 mL)": "Ibuprofen, USP 100 mg (NSAID)** **Nonsteroidal anti-inflammatory drug", "Ask a doctor or pharmacist before use if your child is": "under a doctor's care for any serious condition taking any other drug"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:09.547790 · Updated: 2026-03-14T23:03:04.544899