Label: CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension
- NDC Code(s): 0121-0914-00, 0121-0914-05, 0121-1828-00, 0121-1828-10
- Packager: Pharmaceutical Associates, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 31, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- 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. 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)* under 24 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 *or as directed by a doctor
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Other information
- each 5 mL contains: sodium 2 mg
- store between 20 to 25°C (68 to 77°F)
Children's Ibuprofen Oral Suspension is purple, grape flavored suspension supplied in the following oral dosage forms:
NDC 0121-0914-05: 5 mL unit dose cup
NDC 0121-0914-00: Case contains 100 unit dose cups of 5 mL (0121-0914-05), packaged in 10 trays of 10 unit dose cups each
NDC 0121-1828-10: 10 mL unit dose cup
NDC 0121-1828-00: Case contains 100 unit dose cups of 10 mL (0121-1828-10) packaged in 10 trays of 10 unit dose cups each - Inactive ingredients
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INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN ORAL SUSPENSION
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0914 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 WATER (UNII: 059QF0KO0R) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-0914-00 10 in 1 CASE 06/18/2020 1 10 in 1 TRAY 1 NDC:0121-0914-05 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 ANDA074916 04/30/1999 CHILDRENS IBUPROFEN ORAL SUSPENSION
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1828 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 10 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-1828-00 10 in 1 CASE 06/18/2020 1 10 in 1 TRAY 1 NDC:0121-1828-10 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 ANDA074916 04/30/1999 Labeler - Pharmaceutical Associates, Inc. (044940096) Registrant - Pharmaceutical Associates, Inc. (097630693) Establishment Name Address ID/FEI Business Operations G&W Industries, Inc. 079419931 manufacture(0121-0914, 0121-1828) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 label(0121-0914, 0121-1828)
