NDC 76413-344 Childrens Ibuprofen

NDC Product Code 76413-344

NDC CODE: 76413-344

Proprietary Name: Childrens 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.

Product Characteristics

Color(s):
ORANGE (C48331 - RED)
Flavor(s):
BERRY (C73365)

NDC Code Structure

  • 76413 - Central Texas Community Health Centers

NDC 76413-344-01

Package Description: 118 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Childrens Ibuprofen with NDC 76413-344 is a product labeled by Central Texas Community Health Centers. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 197803.

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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Central Texas Community Health Centers
Labeler Code: 76413
Start Marketing Date: 06-01-2006 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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

Active Ingredient

(in each 5 mL = 1 teaspoon)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 toothachereduces fever

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesshockasthma (wheezing)rashskin reddeningblistersfacial swellingIf 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 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 reducerright before or after heart surgery

Ask 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, or kidney diseasechild has asthmachild is taking a diuretic

Ask 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 occursthe 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 bleedingfeels faintvomits bloodhas bloody or black stoolshas stomach pain that does not get betterthe child does not get any relief within the 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 usingfind right dose on chart.  If possible, use weight to dose; otherwise use age.use only enclosed measuring cupif needed, repeat dose every 6-8 hoursdo not use more than 4 times a dayreplace original bottle cap to maintain child resistance Dosing ChartWeight (lb)Age (yr)Dose (tsp or mL)under 2 yearsask a doctor24 – 35 lbs2 – 3 years1 tsp or 5 mL36 – 47 lbs4 – 5 years1½ tsp or 7.5 mL48 – 59 lbs6 – 8 years2 tsp or 10 mL60 – 71 lbs9 – 10 years2½ tsp or 12.5 mL72 – 95 lbs11 years3 tsp or 15 mLOther informationeach teaspoon contains: sodium 2 mgdo not use if printed neckband is broken or missingstore between 20 - 25°C (68 - 77°F)see bottom panel for lot number and expiration date

Inactive Ingredient

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gumDye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gumBubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

* Please review the disclaimer below.