RxNorm Names
Review RxNorm Normal Forms
CARE ONE IBUPROFEN INFANTS
(ibuprofen)
suspension
[American Sales Company]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ad362e72-7c2f-4985-bc74-08fb2d697bdf| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
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
- •
- 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
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
- •
- 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 (lbs) |
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
- •
- store at 20-25°C (68-77°F)
- •
- do not freeze
- •
- do not use if printed neckband is broken or missing
- •
- see bottom of box for lot number and expiration date
Inactive ingredients
anhydrous citric acid, artificial flavor, butylparaben, FD&C red #40, 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 to 23 mos.
INFANTS'
CONCENTRATED DROPS
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
| CARE ONE IBUPROFEN
INFANTS
ibuprofen suspension |
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| Labeler - American Sales Company (809183973) |
