Label: CHILDRENS IBUPROFEN- ibuprofen suspension
- NDC Code(s): 0121-1836-05
- Packager: Pharmaceutical Associates, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5309
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 6, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
- facial swelling
- asthma (wheezing)
- skin reddening
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
- 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
Dosing Chart Weight (lb) Age (yr) Dose (mL) **or as directed by a doctor Under 24 lbs under 2 years ask a doctor 24–35 lbs 2–3 years 5 mL 36–47 lbs 4–5 years 7.5 mL 48–59 lbs 6–8 years 10 mL 60–71 lbs 9–10 years 12.5 mL 72–95 lbs 11 years 15 mL
- each 5 mL contains: sodium 2 mg
- store at 20° to 25°C (68° to 77°F)
- do not freeze
Children's Ibuprofen Oral Suspension is an orange, berry flavored suspension supplied in the following oral dosage form:
NDC 0121-1836-05: 5 mL unit dose cup. Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1836(NDC:0904-5309) 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 SODIUM BENZOATE (UNII: OJ245FE5EU) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) XANTHAN GUM (UNII: TTV12P4NEE) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) 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:0121-1836-05 10 in 1 CASE 12/01/2014 1 10 in 1 TRAY 1 5 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 12/01/2014 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 repack(0121-1836)