CHILDRENS IBUPROFEN- ibuprofen suspension
Childrens Ibuprofen by
Drug Labeling and Warnings
Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Precision Dose Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purposes
- 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 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
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 ibuprofen or 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, kidney disease, or had a stroke
- 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
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
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
- Use as directed per healthcare professional.
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- shake well before using
- mL = milliliter
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 6-8 hours
- do not use more than 4 times a day
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions or comments?
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How Supplied
NDC: 68094-037-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipperNDC: 68094-494-58
5 mL per unit dose syringe
Fifty (50) syringes per shipperNDC: 68094-494-61
5 mL per unit dose cup
One hundred (100) cups per shipperNDC: 68094-494-62
5 mL per unit dose cup
Thirty (30) cups per shipperNDC: 68094-503-61
10 mL per unit dose cup
One hundred (100) cups per shipperNDC: 68094-503-62
10 mL per unit dose cup
Thirty (30) cups per shipper - SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
NDC: 68094-494-59
PrecisionDose™Children's IBUPROFEN
Oral Suspension 100 mg/5 mLPkg: Precision Dose, Inc. S. Beloit, IL 61080
- PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
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INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 68094-494(NDC:0113-0897) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) D&C yellow NO. 10 (UNII: 35SW5USQ3G) FD&C red NO. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) high fructose corn syrup (UNII: XY6UN3QB6S) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) polysorbate 80 (UNII: 6OZP39ZG8H) sodium benzoate (UNII: OJ245FE5EU) water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color ORANGE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 68094-494-62 3 in 1 CASE 04/13/2004 1 10 in 1 TRAY 1 NDC: 68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC: 68094-494-61 10 in 1 CASE 04/13/2004 2 10 in 1 TRAY 2 NDC: 68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC: 68094-494-58 5 in 1 CASE 04/13/2004 01/31/2025 3 10 in 1 BAG 3 5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074937 04/13/2004 Labeler - Precision Dose Inc. (035886746)
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