Label: CHILDRENS IBUPROFEN- ibuprofen suspension
- NDC Code(s): 60687-743-17, 60687-743-40, 60687-743-46
- Packager: American Health Packaging
- This is a repackaged label.
- Source NDC Code(s): 76281-128
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Drug Facts
- Active ingredient (in each 5 mL cup)
- Purpose
- Uses
-
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
-
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 - *
- or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35 lbs
2-3 years
5 mL (1 unit dose cup)
36-47 lbs
4-5 years
7.5 mL (1.5 unit dose cups)
48-59 lbs
6-8 years
10 mL (2 unit dose cups)
60-71 lbs
9-10 years
12.5 mL (2.5 unit dose cups)
72-95 lbs
11 years
15 mL (3 unit dose cups)
- Other information
- Inactive ingredients:
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
Principal Display Panel – Tray Label
Case NDC 60687-743-17/Cup NDC 60687-743-40
Children’s Ibuprofen
Oral Suspension, USP
(NSAID)100 mg per 5 mL
Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol FreeSHAKE WELL
USUAL DOSAGE: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
For Institutional Use Only.
T1022C050723 R07/23
-
Principal Display Panel – Cup - 100 mg / 5 mL
NDC 60687- 743-40
Children's Ibuprofen
Oral Suspension, USP
(NSAID)
Pain Reliever/Fever Reducer100 mg per 5 ml
Berry Flavored/Dye Free/ Alcohol Free
Delivers 5 mL
SHAKE WELL
See package Drug Facts insert for full
prescribing information and storage.For Institutional Use Only.
American Health Packaging
Columbus, OH 43217A1022C05/1023
-
INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-743(NDC:76281-128) 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-743-17 10 in 1 CASE 12/01/2023 1 NDC:60687-743-46 10 in 1 TRAY 1 NDC:60687-743-40 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 ANDA210602 12/01/2023 Labeler - American Health Packaging (929561009)