SPL v5
SPL
SPL Set ID af0ec23c-cefc-40a9-ab9a-03b8528d4e13
Route
ORAL
Published
Effective Date 2025-09-01
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Raspberry Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Red No. 40 Glycerin Hypromellose 2208 (4000 Mpa.s) Polysorbate 80 Starch, Potato Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 2019-05-06

Description

Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Pain reliever/fever reducer



*nonsteroidal anti-inflammatory drug

Description

Active ingredient (in each 5 mL) Ibuprofen USP 100 mg (NSAID)*

Uses

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 to 8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use


Dosing Chart
* or as directed by a doctor

Weight (lb)

Age (year)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 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
Drug Facts

Active ingredient (in each 5 mL)



Ibuprofen USP 100 mg (NSAID)*

Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not use if carton is opened or seal under cap opening is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients

Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum



Questions or comments?

Call 1-855-274-4122



Distributed by:

7-ELEVEN, INC.

IRVING, TX 75063

www.7-ELEVEN.COM



Made in India



Code: TS/DRUGS/19/1993

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
  • 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
Package Label Principal Display Panel 4 Fl Oz (120 Ml) Carton Label

24/7 life BY 7-ELEVENTM

CHILDREN'S

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/

Fever Reducer (NSAID)

Alcohol Free . Lasts up to 8 Hours

AGES 2 TO 11 YEARS

Use ONLY enclosed dosage cup        Berry Flavor            

4FL OZ (120mL)


Package Label Principal Display Panel 4 Fl Oz (120 Ml) Container label

24/7 life BY 7-ELEVENTM

CHILDREN'S

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/

Fever Reducer (NSAID)

Alcohol Free . Lasts up to 8 Hours

AGES 2 TO 11 YEARS

Berry Flavored             4FL OZ (120 mL)




Structured Label Content

Uses

temporarily:

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

Pain reliever/fever reducer



*nonsteroidal anti-inflammatory drug

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 to 8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use


Dosing Chart
* or as directed by a doctor

Weight (lb)

Age (year)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 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
Drug Facts

Active ingredient (in each 5 mL)



Ibuprofen USP 100 mg (NSAID)*

Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not use if carton is opened or seal under cap opening is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum



Questions or comments?

Call 1-855-274-4122



Distributed by:

7-ELEVEN, INC.

IRVING, TX 75063

www.7-ELEVEN.COM



Made in India



Code: TS/DRUGS/19/1993

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)
  • 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
Package Label Principal Display Panel 4 Fl Oz (120 Ml) Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label)

24/7 life BY 7-ELEVENTM

CHILDREN'S

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/

Fever Reducer (NSAID)

Alcohol Free . Lasts up to 8 Hours

AGES 2 TO 11 YEARS

Use ONLY enclosed dosage cup        Berry Flavor            

4FL OZ (120mL)


Package Label Principal Display Panel 4 Fl Oz (120 Ml) Container label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label)

24/7 life BY 7-ELEVENTM

CHILDREN'S

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/

Fever Reducer (NSAID)

Alcohol Free . Lasts up to 8 Hours

AGES 2 TO 11 YEARS

Berry Flavored             4FL OZ (120 mL)




Advanced Ingredient Data


Raw Label Data

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