NDC 63941-760 Ibuprofen Childrens

Ibuprofen

NDC Product Code 63941-760

NDC Product Information

Ibuprofen Childrens with NDC 63941-760 is a a human over the counter drug product labeled by Valu Merchandisers Company. The generic name of Ibuprofen Childrens is ibuprofen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Valu Merchandisers Company

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.


Ibuprofen Childrens 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/5mL

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: Valu Merchandisers Company
Labeler Code: 63941
FDA Application Number: ANDA074916 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: 01-25-2019 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.

Ibuprofen Childrens Product Label Images

Ibuprofen Childrens 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 5 mL)Ibuprofen, USP 100 mg (NSAID)****nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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.

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

• 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

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 resistanceDosing Chart Weight (lb) Age (yr) Dose (mL)* under 24  under 2 years  ask a doctor  24-35 lbs  2-3 years  5 mL   36-47 lbs 4-5 years   7.5 mL   48-59 lbs  6-8 years  10 mL  60-71 lbs  9-10 years  12.5 mL  72-95 lbs  11 years 15 mL  *or as directed by a doctor

Other Information

• each 5 mL contains: sodium 2 mg• store between 20° to 25°C (68° to 77°F)• do not use if printed neckband is broken or missing• see bottom panel for lot number and expiration date

Inactive Ingredients

Grape: acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

* Please review the disclaimer below.

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