NDC 0363-5100 Infants Ibuprofen

Ibuprofen

NDC Product Code 0363-5100

NDC CODE: 0363-5100

Proprietary Name: Infants 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
BERRY (C73365)

NDC Code Structure

  • 0363 - Walgreens

NDC 0363-5100-01

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC Product Information

Infants Ibuprofen with NDC 0363-5100 is a a human over the counter drug product labeled by Walgreens. The generic name of Infants Ibuprofen is ibuprofen. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 204442.

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.

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.


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.

  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • 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: Walgreens
Labeler Code: 0363
FDA Application Number: ANDA079058 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: 12-04-2020 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

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

Purpose

Pain reliever/Fever reducer

Uses

  • Temporarily:reduces feverrelieves 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:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 problemstakes a blood thinning (anticoagulant) or steroid drugtakes 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 any other pain reliever/fever reducerright before or after heart surgery

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to your childchild has a history of stomach problems, such as heartburnchild has problems or serious side effects from taking pain relievers or fever reducerschild has not been drinking fluidschild has lost a lot of fluid due to vomiting or diarrheachild has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a strokechild has asthmachild is taking a diuretic

Ask A Doctor Or Pharmacist Before Use If The Child Is

  • Under a doctor's care for any serious conditiontaking any other drug

When Using This Product

  • Take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.child experiences any of the following signs of stomach bleeding:feels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get betterchild has symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling     the child does not get any relief within first day (24 hours) of treatmentfever or pain gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center  (1-800-222-1222) right away

Directions

  • This product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingfind right dose on chart below. If possible, use weight to dose; otherwise use age.mL = millilitermeasure with the dosing device provided. Do not use with any other device.dispense liquid slowly into the child's mouth, toward the inner cheekif needed, repeat dose every 6 to 8 hours do not use more than 4 times a day                 Dosing Chart Weight (lb)Age (mos) Dose (mL)  under 6 mos  ask a doctor12 to 17 lbs6 to 11 mos 1.25 mL18 to 23 lbs12 to 23 mos1.875 mL

Other Information

  • Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

Carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

Package Label

WALGREENS Infants' Dye-Free Ibuprofen

* Please review the disclaimer below.