Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
d04a5ea0-0acd-4aaf-8d60-a6b08f3c04a8
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
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
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only enclosed measuring cup
- 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(yrs) | Dose (teaspoonful or mL) |
| under 2 years | ask a doctor | |
| 24-35 lbs | 2-3 years | 1 tsp or 5 mL |
| 36-47 lbs | 4-5 years | 1 ½ tsp or 7.5 mL |
| 48-59 lbs | 6-8 years | 2 tsp or 10 mL |
| 60-71 lbs | 9-10 years | 2 ½ tsp or 12.5 mL |
| 72-95 lbs | 11 years | 3 tsp or 15 mL |
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 teaspoon contains: sodium 2 mg
- do not use if printed neckband is broken or missing
- store at 20-25°C (68-77°F)
- see bottom panel for lot number and expiration date
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
Relabeled by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444
Principal Display Panel
For Ages 2 to 11
Children’s Ibuprofen Oral Suspension
100 mg per 5 mL (teaspoonful)
Pain Reliever
Fever Reducer (NSAID)
Lasts up to 8 hours
See New Warnings Information
Berry Flavored Liquid
Alcohol Free
Children's
COMPARE TO the active ingredient of CHILDREN'S MOTRIN®
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
- the 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
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 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
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only enclosed measuring cup
- 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(yrs) | Dose (teaspoonful or mL) |
| under 2 years | ask a doctor | |
| 24-35 lbs | 2-3 years | 1 tsp or 5 mL |
| 36-47 lbs | 4-5 years | 1 ½ tsp or 7.5 mL |
| 48-59 lbs | 6-8 years | 2 tsp or 10 mL |
| 60-71 lbs | 9-10 years | 2 ½ tsp or 12.5 mL |
| 72-95 lbs | 11 years | 3 tsp or 15 mL |
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 teaspoon contains: sodium 2 mg
- do not use if printed neckband is broken or missing
- store at 20-25°C (68-77°F)
- see bottom panel for lot number and expiration date
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
Relabeled by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444
Principal Display Panel
For Ages 2 to 11
Children’s Ibuprofen Oral Suspension
100 mg per 5 mL (teaspoonful)
Pain Reliever
Fever Reducer (NSAID)
Lasts up to 8 hours
See New Warnings Information
Berry Flavored Liquid
Alcohol Free
Children's
COMPARE TO the active ingredient of CHILDREN'S MOTRIN®
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)
- the 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
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:55:25.045604 · Updated: 2026-03-14T22:53:00.263233