NDC 68210-0011 Assured Ibuprofen

Ibuprofen

NDC Product Code 68210-0011

NDC Code: 68210-0011

Proprietary Name: Assured 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: Ibuprofen 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.


Product Characteristics
Color(s):
ORANGE (C48331)
Shape: CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
G2
Score: 1

Code Structure
  • 68210 - Spirit Pharmaceuticals Llc
    • 68210-0011 - Assured Ibuprofen

NDC 68210-0011-4

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

NDC Product Information

Assured Ibuprofen with NDC 68210-0011 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Assured Ibuprofen is ibuprofen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.


Assured 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
FDA Application Number: ANDA202312 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: 02-25-2019 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.

Assured Ibuprofen Product Label Images

Assured 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

Drug Facts

Active Ingredient(In Each Caplet)

Ibuprofen 200 mg (NSAID)**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pain due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritistemporarily 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 a
  • Nonsteroidal anti-inflammatory drug (NSAID), which
  • May cause severe stomach bleeding. The chance is
  • Higher if you:
  • Are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake 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 directed

Other

Drug Facts (continued)

Heart attack and stroke warning NSAID's except


aspirin increases 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.

Drug Facts (continued)

Drug Facts (continued)

Do Not Use

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

Ask A Doctor Before Use If

¬ the stomach bleeding warning applies to you


¬ you have problems or serious side effects from


taking pain relievers or fever reducers


¬ you have a history of stomach problems, such as


heartburn


¬ you have high blood pressure, heart disease, liver


cirrhosis, kidney disease, asthma or had a stroke


¬ you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

¬ under a doctor's care for any serious condition


¬ taking aspirin for heart attack or stroke, because


ibuprofen may decrease this benefit of aspirin


¬ taking any other drug

When Using This Product

¬ take 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

¬ you experience any of the following signs of stomach


bleeding: ¬ feel faint ¬ vomit blood


¬ have bloody or black stools


¬ have stomach pain that does not get better


¬ you have symptoms of heart problems or stroke:

Otc - Stop Use

¬ chest pain ¬ trouble breathing


¬ leg swelling ¬ slurred speech


¬ weakness in one part or side of body


¬ pain gets worse or lasts more than 10 days


¬ fever gets worse or lasts more than 3 days


¬ redness or swelling is present in the painful area


¬ any new symptoms appear

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

¬ do not take more than directed¬ the smallest effective dose should be used¬ do not take longer than 10 days, unless directed by a


doctor (see Warnings)


¬ adults and children 12 years and over: take 1 caplet


every 4 to 6 hours while symptoms persist


¬ if pain or fever does not respond to 1 caplet, 2


caplets may be used


¬ do not exceed 6 caplets in 24 hours, unless directed


by a doctor


¬ children under 12 years: ask a doctor

Other Information

¬ read all warnings and directions before use.


¬ store between 20°-25°C (68°-77°F)


¬ avoid excessive heat above 40°C (104°F)

Inactive Ingredients

Colloidal silicon


dioxide, FD&C Yellow #6, hypromellose, maize


starch, polydextrose, polyethylene glycol,


povidone k30, pregelatinized starch, sodium


starch glycolate, stearic acid, titanium dioxide.

* Please review the disclaimer below.

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