CHILDRENS IBUPROFEN
-
ibuprofen suspension
Precision Dose Inc.
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CHILDREN'S IBUPROFENORAL SUSPENSION
100 mg/5 mL
200 mg/10 mL
Berry Flavor
For Hospital Use Only
Drug Facts
Active Ingredient (in each 5 mL)
Ibuprofen 100 mg(NSAID)1
- 1
- nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/Fever reducer
Uses
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat,
- headaches and toothaches
- reduces fever
Warnings
Allergy Alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- blisters
- asthma (wheezing)
- shock
- skin reddening
- rash
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 non-prescription)
- 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- use as directed per healthcare professional
- 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 cups well before using
- if needed, repeat dose every 6 - 8 hours
- do not use more than 4 times a day
Other Information
- store at 20-25°C (68-77°F)
- alcohol free
- See individual label or shipper label for lot number and expiration date.
Inactive Ingredients
anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C yellow #6, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum
How Supplied
NDC 68094-494-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper
NDC 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipper
NDC 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipper
NDC 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipper
NDC 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper
Mfg. By: Perrigo
515 Eastern Avenue
Allegan, MI 49010
Pkg. By: Precision Dose, Inc.
722 Progressive Lane
S. Beloit, IL 61080
LI587
Rev. 02/09
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
NDC 68094-494-59
PrecisionDose™
Children's IBUPROFEN
Oral Suspension
100 mg/5 mL
Pkg: Precision Dose, Inc., S. Beloit, IL 61080
PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
NDC# 68094-494-58
Children's IBUPROFEN Oral Suspension, 100 mg/5 mL
Delivers 5 mL (NSAID) Alcohol Free
For Hospital Use Only Protect from freezing
Store at 20°-25°C (68°-77°F)
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY 495 Rev 03/07
PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
NDC 68094-503-59
PrecisionDose™
Children's IBUPROFEN
Oral Suspension
200 mg/10 mL
Delivers 10 mL Shake Well (NSAID) Alcohol Free
Store at 20-25°C (68-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
| CHILDRENS IBUPROFEN
ibuprofen suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074937 | 04/13/2004 | |
| CHILDRENS IBUPROFEN
ibuprofen suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074937 | 09/14/2006 | |
| Labeler - Precision Dose Inc. (035886746) |