LEADER IBUPROFEN
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ibuprofen suspension
Cardinal Health
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Active ingredient (in each 5 mL = 1 teaspoonful)
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.
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
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 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
Ask a doctor or pharmacist before use if the child is
- under a doctor’s care for any serious condition
- taking any other drug
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
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
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- do not give longer than 10 days, unless directed by a doctor (see Warnings)
- 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 |
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, butylparaben, FD&C red #40, flavors, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum
Principal Display Panel
SEE NEW WARNINGS INFORMATION
Compare to Children’s Motrin® active ingredient
For Ages 2-11
CHILDREN'S Ibuprofen Oral Suspension
100 mg per 5 mL (teaspoonful)
Pain Reliever/Fever Reducer (NSAID)
Lasts up to 8 hours
Bubble Gum Flavor
Alcohol Free
Children's Ibuprofen Oral Suspension Carton Image 1
Children's Ibuprofen Oral Suspension Carton Image 2
| LEADER IBUPROFEN
ibuprofen suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074937 | 05/08/2002 | |
| Labeler - Cardinal Health (097537435) |
Revised: 12/2011 Cardinal Health