NDC 53943-119 Childrens Ibuprofen Oral Suspension

Ibuprofen

NDC Product Code 53943-119

NDC 53943-119-24

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Childrens Ibuprofen Oral Suspension with NDC 53943-119 is a a human over the counter drug product labeled by Discount Drug Mart. The generic name of Childrens Ibuprofen Oral Suspension is ibuprofen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Discount Drug Mart

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.

Childrens Ibuprofen Oral Suspension 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

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)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • 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: Discount Drug Mart
Labeler Code: 53943
FDA Application Number: ANDA210602 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: 08-16-2019 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’.

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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]

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Childrens Ibuprofen Oral Suspension 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each 5 mL)Ibuprofen 100 mg (NSAID)

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

Uses temporarily:■ relieves minor aches and pains due to the common cold, flu, sore throat,   headache and toothache■ reduces fever

Warnings

WarningsAllergy alert Ibuprofen may cause a severe allergicreaction, especially in people allergic to aspirin. Symptomsmay include: .   ■ hives  ■ facial swelling  ■asthma (wheezing)   ■ shock ■ skin reddening  ■ rash   ■ blistersIf an allergic reaction occurs, stop use and seek medicalhelp right away.Stomach bleeding warning: This product contains anNSAlD, which may cause severe stomach bleeding. Thechance 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 lor a longer time than directedHeart attack and stroke warning: NSAlDs, exceptaspirin, increase the risk of heart attack, heart failure, andstroke. These can be fatal. The risk is higher if you usemore than directed or lor longer than directed.Sore throat warning: Severe or persistent sore throat orsore throat accompanied by high lever, headache, nausea,and vomiting may be serious. Consult doctor promptly. Donot use more than 2 days or administer to children under 3years of age unless directed by doctor.

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if■ stomach bleeding warning applies to your child■ child has a history of stomach problems, such as   heartbum■ 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is■ under a doctor's care lor any serious condition■ taking any other drug

Otc - When Using

When using this product■ take with food or milk if stomach upset occurs

Otc - Stop Use

Slop 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, getmedical help or contact a Poison Control Center rightaway. (1-800-222-1222)

Dosage & Administration

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 resistance                                       Dosing 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 Safety Information

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

Inactive Ingredient

Inactive ingredientsAcesullame potassium, anhydrous citric acid,carboxymethylcellulose sodium, D&C Yellow #10, FD&CRed #40, flavors, glycerin, microcrystalline cellulose,polysorbate 80, propylene glycol, purified water, sodiumbenzoate, sucrose, and xanthan gum

Otc - Questions

Questions or comments?Call 1-877-798-5944 from 9:30 AM to 4:30 PM EST,Monday-Friday.

Package Labeling

For Ages 2 to 11 YearsDISCOUNT    drug    martFOOD FAIRChildren'sIbuprofenOral Suspension (NSAID)100 mg per 5mLDISCOUNT    drug    martFOOD FAIRNDC 53943-119-24Compare To TheActive Ingredient InChildren's Motrin® **SEE NEW WARNINGSFor Ages 2 to 11 YearsChildren'sIbuprofenOral Suspension (NSAID)100 mg per 5mLPain Reliever/Fever reducerLASTS UP TO 8 HOURSALCOHOL FREEOriginal Berry Flavor4 FL OZ (118 mL)Important: Read all product information before using.Keep this box for important information.This product is intended for use in children.**This product is not manufactured or distributed by McNeilConsumer Healthcare, distributor of Children's Motrin®.SATISFACTION GUARANTEEDIF DISSATISFIED, RETURN UNUSED PORTION ANDPACKAGE TO STORE WHERE PURCHASED. IF UNABLE TORETURN TO STORE, SEND REASON FOR DISSATISFACTION,NAME, ADDRESS, AND EMPTY PACKAGE TO:DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256BX-0820  93351 02962  201078436Box LabelBottle Labelres

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