Label: HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-057-05 - Packager: Dolgencorp Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 22, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 1.25 mL)
- Purpose
- Uses
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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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 child has
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- not been drinking fluids
- lost a lot of fluid due to vomiting or diarrhea
- high blood pressure
- heart or kidney disease
- taken a diuretic
Ask a doctor or pharmacist before use if the child is
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- 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
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if
- the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
- stomach pain or upset gets worse or lasts
- 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
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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 the right dose on chart below. If possible, use weight to dose; otherwise use age.
- measure with 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
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg in 1.25 mL Product Characteristics Color PINK (light) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-057-05 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075217 06/08/2009 Labeler - Dolgencorp Inc (068331990)
