Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
230914e6-fe0c-45be-8b2e-e066c71d004c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Uses
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Purposes
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
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; tsp = teaspoonful
- 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 6-8 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 |
||
|
Weight (lb) |
Age (yr) |
Dose (mL or tsp)** |
|
under 24 lbs |
under 2 years |
ask a doctor |
|
24-35 lbs |
2-3 years |
5 mL (1 tsp) |
|
36-47 lbs |
4-5 years |
7.5 mL (1½ tsp) |
|
48-59 lbs |
6-8 years |
10 mL (2 tsp) |
|
60-71 lbs |
9-10 years |
12.5 mL (2½ tsp) |
|
72-95 lbs |
11 years |
15 mL (3 tsp) |
**or as directed by a doctor
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
Other Information
- each 5 mL (1 tsp) contains: sodium 2 mg
- do not use if printed neckband is broken or missing
- store at 20-25 C (68-77 F) ° °
- do not freeze
- see bottom panel for lot number and expiration date
Ibuprofen Suspension
Inactive Ingredients
anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
Questions Or Comments?
1-800-719-9260
When Using This Product
- give with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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, or kidney disease
- 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
- 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)
Active Ingredient (in Each 5 Ml = 1 Teaspoonful)
Ibuprofen 100 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:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Purposes
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
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; tsp = teaspoonful
- 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 6-8 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 |
||
|
Weight (lb) |
Age (yr) |
Dose (mL or tsp)** |
|
under 24 lbs |
under 2 years |
ask a doctor |
|
24-35 lbs |
2-3 years |
5 mL (1 tsp) |
|
36-47 lbs |
4-5 years |
7.5 mL (1½ tsp) |
|
48-59 lbs |
6-8 years |
10 mL (2 tsp) |
|
60-71 lbs |
9-10 years |
12.5 mL (2½ tsp) |
|
72-95 lbs |
11 years |
15 mL (3 tsp) |
**or as directed by a doctor
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
Other Information (Other information)
- each 5 mL (1 tsp) contains: sodium 2 mg
- do not use if printed neckband is broken or missing
- store at 20-25 C (68-77 F) ° °
- do not freeze
- see bottom panel for lot number and expiration date
Ibuprofen Suspension (IBUPROFEN SUSPENSION)
Inactive Ingredients (Inactive ingredients)
anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
Questions Or Comments? (Questions or comments?)
1-800-719-9260
When Using This Product (When using this product)
- give with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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, or kidney disease
- 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
- 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)
Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active ingredient (in each 5 mL = 1 teaspoonful))
Ibuprofen 100 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
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:06.541761 · Updated: 2026-03-14T23:08:42.212838