SPL v3
SPL
SPL Set ID fab39a0a-882b-bf96-e053-6294a90a2932
Route
ORAL
Published
Effective Date 2025-09-02
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 2025-03-21
Description

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

Medication Information

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


Section 55105-1

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Section 55106-9

Active ingredient (in each 5 mL)



Ibuprofen USP 100 mg (NSAID)*

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


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, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum



Questions or comments?



Call 1-855-274-4122



DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O.BOX 99, PLEASANTON

CA 94566-0009

‡1-888-723-3929

Made in India

  



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 8 Fl Oz (240 Ml) Carton Label

Compare to

Children's Motrin®

active ingredient**

 

NDC 21130-216-20

Signature

care®

Quality

Guranteed

 

FOR

AGES 2 TO 11 YEARS

Children’s

Ibuprofen

ORAL SUSPENSION USP

100 mg per 5 mL

Pain Reliever/Fever Reducer

(NSAID)

BERRY

FLAVOR

 •   Lasts up to 8 hours

•   Alcohol free

Use ONLY enclosed

dosage cup

8 FL OZ (240 mL)

 

 



Package Label Principal Display Panel 8 Fl Oz (240 Ml) Container Label

NDC 21130-216-20

 

Signature

care®

 

Quality

Guranteed

FOR

AGES 2 to 11 YEARS

Children’s

Ibuprofen

ORAL SUSPENSION USP

100 mg per 5 mL

 

Pain Reliever/Fever Reducer

(NSAID)

•   Lasts up to 8 hours

•   Alcohol free

 

BERRY FLAVOR

8 FL OZ (240 mL)

  



Structured Label Content

Uses

temporarily:

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


Section 55105-1 (55105-1)

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)



Ibuprofen USP 100 mg (NSAID)*

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


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, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum



Questions or comments?



Call 1-855-274-4122



DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O.BOX 99, PLEASANTON

CA 94566-0009

‡1-888-723-3929

Made in India

  



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 8 Fl Oz (240 Ml) Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Carton Label)

Compare to

Children's Motrin®

active ingredient**

 

NDC 21130-216-20

Signature

care®

Quality

Guranteed

 

FOR

AGES 2 TO 11 YEARS

Children’s

Ibuprofen

ORAL SUSPENSION USP

100 mg per 5 mL

Pain Reliever/Fever Reducer

(NSAID)

BERRY

FLAVOR

 •   Lasts up to 8 hours

•   Alcohol free

Use ONLY enclosed

dosage cup

8 FL OZ (240 mL)

 

 



Package Label Principal Display Panel 8 Fl Oz (240 Ml) Container Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL) Container Label)

NDC 21130-216-20

 

Signature

care®

 

Quality

Guranteed

FOR

AGES 2 to 11 YEARS

Children’s

Ibuprofen

ORAL SUSPENSION USP

100 mg per 5 mL

 

Pain Reliever/Fever Reducer

(NSAID)

•   Lasts up to 8 hours

•   Alcohol free

 

BERRY FLAVOR

8 FL OZ (240 mL)

  



Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.250688 · Updated: 2026-03-14T23:10:05.459246