NDC 36800-057 Topcare Infants Ibuprofen

Ibuprofen

NDC Product Code 36800-057

NDC 36800-057-05

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC Product Information

Topcare Infants Ibuprofen with NDC 36800-057 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Infants Ibuprofen is ibuprofen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Topco Associates Llc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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 Infants 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 50 mg/1.25mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: ANDA075217 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: 01-22-2002 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: 12-31-2021 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.

Information for Patients

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]

* Please review the disclaimer below.

Topcare Infants Ibuprofen Product Label Images

Topcare Infants 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 1.25 Ml)

Ibuprofen 50 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 directedSore 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

  • •the 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, or kidney disease •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

  • •give with food or milk if stomach upset occurs •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 •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 •find right dose on chart below. If possible, use weight to dose; otherwise use age. •measure with the dosing device provided. Do not use with any other device. •dispense liquid slowly into the child’s mouth, toward the inner cheek •if needed, repeat dose every 6-8 hours •do not use more than 4 times a dayDosing ChartWeight (lbs)Age (mos)Dose (mL)under 6 mosask a doctor12-17 lbs6-11 mos1.25 mL18-23 lbs12-23 mos1.875 mL

Other Information

  • •store at 20-25°C (68-77°F) •do not freeze •do not use if printed neckband is broken or missing •see bottom of box for lot number and expiration date

Inactive Ingredients

Anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

* Please review the disclaimer below.