CHILDRENS IBUPROFEN- ibuprofen suspension
CHILDRENS Ibuprofen by
Drug Labeling and Warnings
CHILDRENS Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- 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 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
- 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 below. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 6 to 8 hours
- do not use more than 4 times a day
Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 5 mL 36 to 47 lbs 4 to 5 years 7.5 mL 48 to 59 lbs 6 to 8 years 10 mL 60 to 71 lbs 9 to 10 years 12.5 mL 72 to 95 lbs 11 years 15 mL *or as directed by a doctor
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Other information
- each 5 mL contains: sodium 2 mg
- store at 20°C to 25°C (68°F to 77°F)
- CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms:
NDC: 81033-019-05: 5 mL unit-dose cup
NDC: 81033-019-01: Case containing 100 unit-dose cups of 5 mL each.
NDC: 81033-019-10: 10 mL unit-dose cupNDC: 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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Principal Display Panel
NDC: 81033-019-01
CHLIDREN'S Ibuprofen Oral Suspension, USP
100 mg per 5 mL
Delivers 5 mL
Case = 100 UD Cups (Do Not Break Case)
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PRINCIPAL DISPLAY PANEL
NDC: 81033-019-02
CHILDREN'S Ibuprofen Oral Suspension, USP
200 mg per 10 mL
Delivers 10 mL
Case = 100 UD Cups (Do Not Break Case)
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INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 81033-019 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) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 81033-019-01 100 in 1 CASE 11/01/2025 1 NDC: 81033-019-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC: 81033-019-02 100 in 1 CASE 11/01/2025 2 NDC: 81033-019-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074937 04/28/2011 Labeler - Kesin Pharma Corporation (117447816) Establishment Name Address ID/FEI Business Operations Kesin Pharma Corporation 117447816 label(81033-019) , pack(81033-019)
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