FDA Label for Ibuprofen Oral
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- PRINCIPAL DISPLAY PANEL
Ibuprofen Oral Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
(in each 5 mL)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Use(S)
temporarily:
• relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache• reduces fever
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• 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.
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:
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, 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
When Using This Product
• take with food or milk if stomach upset occurs
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
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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
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*or as directed by a doctor
Other Information
• each 5 mL contains : sodium 2 mg• store between 20-25°C (68-77°F)• do not use if carton is opened or printed bottle neckband is broken or missing• see bottom panel for lot number and expiration date
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
Call 1-888-588-1418 from 9 AM to 5 PM EST,
Monday-Friday.
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA
Relabeled By: Preferred Pharmaceuticals Inc.
Principal Display Panel
Ibuprofen oral suspension berry flavor with dye container carton
* Please review the disclaimer below.