Children's Ibuprofen Oral Suspension, Usp
436c0126-4ff3-c082-e063-6294a90a3d72
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each 5 mL)………………….………………………………..………..Purpose Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer
Medication Information
Purpose
Pain reliever/Fever reducer
Description
Active ingredient (in each 5 mL)………………….………………………………..………..Purpose Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug
Uses
Temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Section 42229-5
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
Section 51945-4
NDC: 81033-019-02
CHILDREN'S Ibuprofen Oral Suspension, USP
200 mg per 10 mL
Delivers 10 mL
Case = 100 UD Cups (Do Not Break Case)
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.
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 below. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 6 to 8 hours
- do not use more than 4 times a day
| Weight (lb) | Age (yr) | Dose (mL) |
| under 24 | under 2 years | ask a doctor |
| 24 to 35 lbs | 2 to 3 years | 5 mL |
| 36 to 47 lbs | 4 to 5 years | 7.5 mL |
| 48 to 59 lbs | 6 to 8 years | 10 mL |
| 60 to 71 lbs | 9 to 10 years | 12.5 mL |
| 72 to 95 lbs | 11 years | 15 mL |
*or as directed by a doctor
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)………………….………………………………..………..Purpose
Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer
*nonsteroidal anti-inflammatory drug
Other Information
- each 5 mL contains: sodium 2 mg
- store at 20°C to 25°C (68°F to 77°F)
- CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms:
NDC 81033-019-05: 5 mL unit-dose cup
NDC 81033-019-01: Case containing 100 unit-dose cups of 5 mL each.
NDC 81033-019-10: 10 mL unit-dose cup
NDC 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.
Inactive Ingredients
anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
Questions Or Comments?
Call 1-833-537-4679
Principal Display Panel
NDC: 81033-019-01
CHLIDREN'S Ibuprofen Oral Suspension, USP
100 mg per 5 mL
Delivers 5 mL
Case = 100 UD Cups (Do Not Break Case)
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
Structured Label Content
Uses
Temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Section 42229-5 (42229-5)
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
Section 51945-4 (51945-4)
NDC: 81033-019-02
CHILDREN'S Ibuprofen Oral Suspension, USP
200 mg per 10 mL
Delivers 10 mL
Case = 100 UD Cups (Do Not Break Case)
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.
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 below. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 6 to 8 hours
- do not use more than 4 times a day
| Weight (lb) | Age (yr) | Dose (mL) |
| under 24 | under 2 years | ask a doctor |
| 24 to 35 lbs | 2 to 3 years | 5 mL |
| 36 to 47 lbs | 4 to 5 years | 7.5 mL |
| 48 to 59 lbs | 6 to 8 years | 10 mL |
| 60 to 71 lbs | 9 to 10 years | 12.5 mL |
| 72 to 95 lbs | 11 years | 15 mL |
*or as directed by a doctor
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)………………….………………………………..………..Purpose
Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer
*nonsteroidal anti-inflammatory drug
Other Information (Other information)
- each 5 mL contains: sodium 2 mg
- store at 20°C to 25°C (68°F to 77°F)
- CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms:
NDC 81033-019-05: 5 mL unit-dose cup
NDC 81033-019-01: Case containing 100 unit-dose cups of 5 mL each.
NDC 81033-019-10: 10 mL unit-dose cup
NDC 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.
Inactive Ingredients (Inactive ingredients)
anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
Questions Or Comments? (Questions or comments?)
Call 1-833-537-4679
Principal Display Panel
NDC: 81033-019-01
CHLIDREN'S Ibuprofen Oral Suspension, USP
100 mg per 5 mL
Delivers 5 mL
Case = 100 UD Cups (Do Not Break Case)
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
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Source: dailymed · Ingested: 2026-02-15T12:09:02.759257 · Updated: 2026-03-14T23:13:35.542610