NDC 76413-312 Ibuprofen

NDC Product Code 76413-312

NDC CODE: 76413-312

Proprietary Name: 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: 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 relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is 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. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
PINK (C48328 - LIGHT)
Flavor(s):
FRUIT (C73389 - MIXED)

NDC Code Structure

  • 76413 - Central Texas Community Health Centers

NDC 76413-312-15

Package Description: 1 BOTTLE in 1 CARTON > 15 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

Ibuprofen with NDC 76413-312 is a product labeled by Central Texas Community Health Centers. The generic name of Ibuprofen is . The product's dosage form is and is administered via form.

Labeler Name: Central Texas Community Health Centers

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • 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)
  • SORBITOL (UNII: 506T60A25R)
  • 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: 08-28-2003 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.

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]

* Please review the disclaimer below.

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

Purposes

Pain reliever/fever reducer

Uses

  • Temporarily: •reduces fever •relieves 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: •hives •facial swelling •asthma (wheezing) •shock •skin reddening •rash •blistersIf 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 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 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, or kidney disease •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

  • •give with food or milk if stomach upset occurs •the 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 bleeding: •feels faint •vomits blood •has bloody or black stools •has stomach pain that does not get better •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

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 use •do not give more than directed •shake well before using •find right dose on chart below. If possible, use weight to dose; otherwise use age. •measure with the dosing device provided. Do not use with any other device. •dispense liquid slowly into the child's mouth, toward the inner cheek •if needed, repeat dose every 6-8 hours •do not use more than 4 times a dayDosing ChartWeight (lbs)Age (mos)Dose (mL)under 6 mosask a doctor12-17 lbs6-11 mos1.25 mL18-23 lbs12-23 mos1.875 mL

Other Information

  • •store at 20-25°C (68-77°F) •do not freeze •do not use if printed neckband is broken or missing •see bottom of box for lot number and expiration date

Inactive Ingredients

Anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

* Please review the disclaimer below.