NDC 58602-843 Ibuprofen

Ibuprofen

NDC Product Code 58602-843

NDC 58602-843-12

Package Description: 1 BOTTLE in 1 CARTON > 40 CAPSULE in 1 BOTTLE

NDC 58602-843-18

Package Description: 1 BOTTLE in 1 CARTON > 80 CAPSULE in 1 BOTTLE

NDC 58602-843-30

Package Description: 160 CAPSULE in 1 BOTTLE

NDC 58602-843-32

Package Description: 180 CAPSULE in 1 BOTTLE

NDC 58602-843-38

Package Description: 300 CAPSULE in 1 BOTTLE

NDC 58602-843-73

Package Description: 1 BOTTLE in 1 CARTON > 20 CAPSULE in 1 BOTTLE

NDC 58602-843-79

Package Description: 2 BOTTLE in 1 CARTON > 180 CAPSULE in 1 BOTTLE

NDC Product Information

Ibuprofen with NDC 58602-843 is a a human over the counter drug product labeled by Aurohealth Llc. The generic name of Ibuprofen is ibuprofen. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Aurohealth Llc

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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 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 200 mg/1

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.

  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • SORBITOL (UNII: 506T60A25R)
  • 1,4-SORBITAN (UNII: AV0YTZ4E6J)
  • MANNITOL (UNII: 3OWL53L36A)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Aurohealth Llc
Labeler Code: 58602
FDA Application Number: ANDA207753 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: 07-15-2020 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: 12-31-2021 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 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 capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

  • Temporarily relieves minor aches and pains due to: headachetoothache backachemenstrual crampsmuscular achesthe common cold minor pain of arthritis temporarily reduces 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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.

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor’s care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking any other drug

When Using This Product

  • Take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better■ you have symptoms of heart problems or stroke:     ■ chest pain                 ■ trouble breathing     ■ weakness in one part or side of body     ■ slurred speech           ■ leg swelling pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than directedthe smallest effective dose should be usedadults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be useddo not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Other Information

  • Each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton.store at 20° to 25°C (68° to 77°F)avoid excessive heat above 40°C (104°F)

Inactive Ingredients

FD & C green no. 3,  gelatin,  polyethylene glycol, potassium hydroxide, purified water and sorbitol sorbitan solution.Questions or comments? call 1-855-274-4122 Distributed by:AUROHEALTH LLC2572 Brunswick PikeLawrenceville, NJ 08648 Made in India    Code No.: TS/DRUGS/16/2014 Issued: July 2020

* Please review the disclaimer below.