NDC 36800-811 Topcare Childrens Ibuprofen

Ibuprofen

NDC Product Code 36800-811

NDC Code: 36800-811

Proprietary Name: Topcare Childrens Ibuprofen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ibuprofen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
L461
Score: 2
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 36800 - Topco Associates Llc

NDC 36800-811-62

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Topcare Childrens Ibuprofen with NDC 36800-811 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Childrens Ibuprofen is ibuprofen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Topcare Childrens Ibuprofen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • IBUPROFEN 100 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • SUCCINIC ACID (UNII: AB6MNQ6J6L)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: ANDA076359 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-04-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Topcare Childrens Ibuprofen Product Label Images

Topcare Childrens Ibuprofen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Chewable Tablet)

Ibuprofen 100 mg (NSAID)**nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

  • Temporarily: •reduces fever •relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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 •blistersIf 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 directedHeart 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 ibuprofen or 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

  • •mouth or throat burning may occur; give with food or water •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

  • •chew or crush tablets completely before swallowing •this product does not contain directions or complete warnings for adult use •do not give more than directed •find right dose on chart below. If possible, use weight to dose; otherwise use age. •if needed, repeat dose every 6-8 hours •do not use more than 4 times a dayDosing ChartWeight (lb)Age (yr)Tabletsunder 24under 2ask a doctor24-352-3136-474-51 ½48-596-8260-719-102 ½72-95113

Other Information

  • •phenylketonurics: contains phenylalanine 6 mg per tablet •store between 20-25°C (68-77°F) •do not use if printed seal under cap is broken or missing

Inactive Ingredients

Acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

* Please review the disclaimer below.