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| Product NDC Code | 69230-308 | ||||
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| Drug Name | Ibuprofen oral |
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| Type | Generic | ||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 197803 | ||||
| Application Number | ANDA210602 | ||||
| Labeler Name | Camber Consumer Care Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT(S) (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Purpose
Information about the drug product’s indications for use.PURPOSE Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM D&C YELLOW NO. 10 GLYCERIN FD&C RED NO. 40 CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROFEN Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM FD&C BLUE NO. 1 D&C RED NO. 33 IBUPROFEN IBUPROFEN Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM FD&C RED NO. 40 D&C RED NO. 33 IBUPROFEN IBUPROFEN Ibuprofen Oral Ibuprofen Oral ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE XANTHAN GUM IBUPROFEN IBUPROFEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Ibuprofen oral suspension berry flavor with dye container carton Ibuprofen oral suspension berry flavor with dye free container carton Ibuprofen oral suspension grape flavor container carton Ibuprofen oral suspension bubble gum flavor container carton original berry flavour original berry flavour with dye free grape flavour bubble gum flavour
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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 ibuprofencamberlogo
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the 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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API