Label: IBUPROFEN ORAL suspension
- NDC Code(s): 68788-7984-1
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 69230-308
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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
-
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
- WHEN USING THIS PRODUCT
-
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
- KEEP OUT OF REACH OF CHILDREN
-
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.
· 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
Dosing Chart
Weight (lb)
under 24
24-35 lbs
36-47 lbs
48-59 lbs
60-71 lbs
72-95 lbs
Age (yr)
under 2 years
2-3 years
4-5 years
6-8 years
9-10 years
11 years
Dose (mL)*
ask a doctor
5 mL
7.5 mL
10 mL
12.5 mL
15 mL*or as directed by a doctor
- Other information
-
INACTIVE INGREDIENT SECTION
Berry flavor (with dye)
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
Berry flavor (dye free)
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
Grape flavor
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Blue #1, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
Bubble Gum flavor
Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Red #33, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.
- QUESTIONS SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN ORAL
ibuprofen oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7984(NDC:69230-308) 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 (1.3 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 600 MPA.S AT 2%) (UNII: 72QQR5RYU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) 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 ORANGE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7984-1 1 in 1 CARTON 08/05/2021 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210602 08/05/2021 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7984)
