Ibuprofen by Atlantic Biologicals Corps IBUPROFEN suspension
Ibuprofen by
Drug Labeling and Warnings
Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Atlantic Biologicals Corps. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each 5 mL = 1 teaspoonful)
- Purposes
- 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
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 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, or kidney disease
- 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
When using this product
- give with food or milk if stomach upset occurs
- 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
- 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
- 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; tsp = teaspoonful
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- use only enclosed dosing cup. Do not use any other dosing device.
- if needed, repeat dose every 6-8 hours
- do not use more than 4 times a day
- replace original bottle cap to maintain child resistance
- 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
-
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 0: Not a Combination Product 09/20/2019 2 NDC: 17856-5309-2 10 mL in 1 SYRINGE; Type 0: Not a Combination Product 09/20/2019 09/20/2019 3 NDC: 17856-5309-3 1 mL in 1 SYRINGE; Type 0: Not a Combination Product 09/20/2019 09/20/2019 4 NDC: 17856-5309-4 20 mL in 1 CUP; Type 0: Not a Combination Product 09/20/2019 5 NDC: 17856-5309-5 5 mL in 1 CUP; Type 0: Not a Combination Product 09/20/2019 6 NDC: 17856-5309-6 15 mL in 1 CUP; Type 0: Not a Combination Product 09/20/2019 7 NDC: 17856-5309-7 7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 09/20/2019 8 NDC: 17856-5309-9 1 mL in 1 SYRINGE; Type 0: Not a Combination Product 09/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074937 02/07/1999 Labeler - Atlantic Biologicals Corps (047437707) Registrant - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL(17856-5309) , REPACK(17856-5309)
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