Label: IBUPROFEN suspension
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NDC Code(s):
17856-5309-1,
17856-5309-2,
17856-5309-3,
17856-5309-4, view more17856-5309-5, 17856-5309-6, 17856-5309-7, 17856-5309-9
- Packager: ATLANTIC BIOLOGICALS CORP.
- 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
Drug Label Information
Updated December 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL = 1 teaspoonful)
- 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:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- takes more or for a longer time 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
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- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- stomach bleeding warning applies to your child
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- child has a history of stomach problems, such as heartburn
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- child has problems or serious side effects from taking pain relievers or fever reducers
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- child has not been drinking fluids
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- child has lost a lot of fluid due to vomiting or diarrhea
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- child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- child has asthma
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- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
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- under a doctor’s care for any serious condition
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- taking any other drug
When using this product
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- give with food or milk if stomach upset occurs
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- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
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- child experiences any of the following signs of stomach bleeding
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- the child does not get any relief within first day (24 hours) of treatment
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- fever or pain gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- shake well before using
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- mL = milliliter; tsp = teaspoonful
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- find right dose on chart. If possible, use weight to dose; otherwise use age.
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- use only enclosed dosing cup. Do not use any other dosing device.
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- if needed, repeat dose every 6-8 hours
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- do not use more than 4 times a day
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- replace original bottle cap to maintain child resistance
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- wash dosage cup after each use
Dosing Chart
Weight (lb)
Age (yr)
Dose (mL or tsp)**
under 24 lbs
under 2 years
ask a doctor
24-35 lbs
2-3 years
5 mL (1 tsp)
36-47 lbs
4-5 years
7.5 mL (1½ tsp)
48-59 lbs
6-8 years
10 mL (2 tsp)
60-71 lbs
9-10 years
12.5 mL (2½ tsp)
72-95 lbs
11 years
15 mL (3 tsp)
**or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- IBUPROFEN SUSPENSION
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5309(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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) HYPROMELLOSES (UNII: 3NXW29V3WO) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:17856-5309-1 5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 01/28/2021 2 NDC:17856-5309-2 10 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 09/20/2019 09/20/2019 3 NDC:17856-5309-3 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 09/20/2019 09/20/2019 4 NDC:17856-5309-4 20 mL in 1 CUP; Type 0: Not a Combination Product 01/28/2021 5 NDC:17856-5309-5 5 mL in 1 CUP; Type 0: Not a Combination Product 01/28/2021 6 NDC:17856-5309-6 15 mL in 1 CUP; Type 0: Not a Combination Product 01/28/2021 7 NDC:17856-5309-7 7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 01/28/2021 8 NDC:17856-5309-9 1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 01/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074937 02/07/1999 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 REPACK(17856-5309)
