NDC 10202-711 Childrens Ibuprofen

Ibuprofen

NDC Product Code 10202-711

NDC 10202-711-24

Package Description: 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE

NDC Product Information

Childrens Ibuprofen with NDC 10202-711 is a a human over the counter drug product labeled by 7-eleven. The generic name of Childrens Ibuprofen is ibuprofen. The product's dosage form is suspension and is administered via oral form.

Labeler Name: 7-eleven

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 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)
  • RASPBERRY (UNII: 4N14V5R27W)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • STARCH, POTATO (UNII: 8I089SAH3T)
  • 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: 7-eleven
Labeler Code: 10202
FDA Application Number: ANDA209179 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: 05-06-2019 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.

Childrens Ibuprofen Product Label Images

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

Drug Facts

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

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

Uses

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

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 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 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 diarrhea child 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

  • 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 pain trouble breathing weakness in one part or side of body slurred speech leg swellingthe 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 right away. (1-800-222-1222)

Directions

  • This product does not contain directions or complete warnings for adult usedo not give more than directedshake well before usingmL = milliliterfind 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 to 8 hoursdo not use more than 4 times a dayreplace original bottle cap to maintain child resistancewash dosage cup after each useDosing Chart
  • * or as directed by a doctorWeight (lb)Age (year)Dose (mL)*under 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years15 mL

Other Information

  • Each 5 mL contains: sodium 2 mgstore between 20 to 25°C (68 to 77°F)do not use if carton is opened or seal under cap opening is broken or missingsee bottom panel for lot number and expiration date

Inactive Ingredients

Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum Questions or comments?Call 1-855-274-4122 Distributed by:7-ELEVEN, INC.IRVING, TX 75063www.7-ELEVEN.COM Made in India Code: TS/DRUGS/19/1993

* Please review the disclaimer below.

Previous Code
10202-701
Next Code
10202-712