CARE ONE IBUPROFEN INFANTS
-
ibuprofen suspension
American Sales Company
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Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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 the 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 then 10 days, unless directed by a doctor (see Warnings)
- shake well before using
- find right dose on chart below. If possible, use weight to dose; otherwise use age.
- measure with the dosing device provided. Do not use with any other device.
- dispense liquid slowly into the child’s mouth, toward the inner cheek
- if needed, repeat dose every 6-8 hours
- do not use more than 4 times a day
| Dosing Chart | ||
| Weight (lb) | Age (mos) | Dose (mL) |
| under 6 mos | ask a doctor | |
| 12-17 lbs | 6-11 mos | 1.25 mL |
| 18-23 lbs | 12-23 mos | 1.875 mL |
Other information
- do not use if printed neckband is broken or missing
- store at 20-25°C (68-77°F)
- see bottom of box for lot number and expiration date
Inactive ingredients
anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Principal Display Panel
Compare to the Active Ingredient in Motrin® Infants’ Drops
For Ages 6 - 23 mos.
INFANTS'
CONCENTRATED
IBUPROFEN ORAL SUSPENSION
50 mg per 1.25 mL
PAIN RELIEVER/FEVER REDUCER (NSAID)
BERRY FLAVOR
Lasts up to 8 hours
Alcohol Free
Use Only with Enclosed Syringe
See New Warnings Information
Ibuprofen Oral Suspension Carton Image 1
Ibuprofen Oral Suspension Carton Image 2
| CARE ONE IBUPROFEN
INFANTS
ibuprofen suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075217 | 05/11/2004 | |
| Labeler - American Sales Company (809183973) |
Revised: 05/2009 American Sales Company