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| Product NDC Code | 0573-0232 | ||||
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| Drug Name | Childrens advil |
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| Type | Brand | ||||
| 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, 206878 |
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| Application Number | NDA020589 | ||||
| Labeler Name | Haleon US Holdings LLC | ||||
| 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 (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 below. If possible, use weight to dose; otherwise use age. • repeat dose every 6-8 hours , if needed • do not use more than 4 times a day • measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension. Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 lb under 2 yr ask a doctor 24-35 lb 2-3 yr 5 mL 36-47 lb 4-5 yr 7.5 mL 48-59 lb 6-8 yr 10 mL 60-71 lb 9-10 yr 12.5 mL 72-95 lb 11 yr 15 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Children's Advil Suspension Fruit Flavor artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Blue Raspberry Flavor artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension White Grape Flavor acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Bubblegum Flavor carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, natural and artificial flavor, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum Children's Advil Suspension Sugar-Free Dye-Free Berry artificial flavor, +orbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, 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.USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose
Information about the drug product’s indications for use.PURPOSE Fever reducer/Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCROSE XANTHAN GUM Translucent, medium dark blue CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN ACETIC ACID BUTYLATED HYDROXYTOLUENE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL FD&C RED NO. 40 WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM Translucent purple CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM Translucent red CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN ACETIC ACID BUTYLATED HYDROXYTOLUENE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCROSE XANTHAN GUM CHILDRENS ADVIL ibuprofen IBUPROFEN IBUPROFEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CITRIC ACID MONOHYDRATE EDETATE DISODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM
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 NDC 0573-0174-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours BLUE RASPBERRY! Blue Raspberry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Blue Raspberry
PRINCIPAL DISPLAY PANEL NDC 0573-0171-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Grape-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Grape
PRINCIPAL DISPLAY PANEL NDC 0573-0170-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Fruit-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Fruit
PRINCIPAL DISPLAY PANEL NDC0573-0290-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free WHITE GRAPE White Grape-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton White Grape
PRINCIPAL DISPLAY PANEL NDC 0573-0207-30 Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Bubble Gum Bubble Gum-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Bubble Gum
PRINCIPAL DISPLAY PANEL NDC 0573-0232-30 SUGAR-FREE Children's Advil ® Suspension Ibuprofen Oral Suspension 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Fever Aches & Pains Lasts Up To 8 Hours Dye-Free BERRY Berry-Flavored Liquid for ages 2-11 years 4 FL OZ (120 mL) Alcohol-Free 120 mL Bottle Carton Berry
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 Children's Advil Suspension Fruit Flavor; Children's Advil Suspension Grape Flavor; Children's Advil Suspension White Grape Flavor; Children's Advil Bubblegum • each 5 mL contains: sodium 3 mg • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see bottom of box for lot number and expiration date Children's Advil Suspension Blue Raspberry Flavor; Children's Advil Suspension Sugar-Free Dye-Free Berry Flavor • each 5 mL contains: sodium 10 mg • one dose lasts 6-8 hours • store at 20-25°C (68-77°F) • see bottom of box 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 the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
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 the 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 • 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 the child • child has problems or serious side effects from taking pain relievers or fever reducers • child has a history of stomach problems, such as heartburn • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • 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.
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