NDC 54473-308 Counteract IB

Ibuprofen

NDC Product Code 54473-308

NDC Code: 54473-308

Proprietary Name: Counteract IB 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):
BROWN (C48332 - BROWN)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
114
Score: 1

NDC Code Structure

  • 54473 - Melaleuca, Inc

NDC 54473-308-50

Package Description: 1 BOTTLE in 1 BOX > 50 TABLET, COATED in 1 BOTTLE

NDC Product Information

Counteract IB with NDC 54473-308 is a a human over the counter drug product labeled by Melaleuca, Inc. The generic name of Counteract IB is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Melaleuca, Inc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Counteract IB 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.

  • CROSCARMELLOSE (UNII: 029TFK992N)
  • TALC (UNII: 7SEV7J4R1U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • 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: Melaleuca, Inc
Labeler Code: 54473
FDA Application Number: ANDA091239 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: 08-15-2019 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.

Counteract IB 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

Otc - Purpose

Purpose
Pain reliever/fever reducer

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual crampstemporarily reduces fever

Otc - Do Not Use

  • Do not useif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery

Otc - Ask Doctor

  • Ask a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersthe stomach bleeding warning applies to youyou have a history of stomach problems such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou have asthmayou are taking a diuretic

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor's care for any serious conditiontaking any other drugtaking any other drug containing an NSAID (prescription or nonprescription)taking a blood thinning (anticoagulant) or steroid drug

Otc - When Using

  • When using this producttake with food or milk if stomach upset occurslong term continuous use may increase the risk of heart attack or stroke

Otc - Stop Use

  • Stop use and ask a doctor ifyou experience any of the following signs of bleeding:feel faintvomit bloodhave blood ro black stoolshave stomach pain that does not get betterpain 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

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).

Dosage & Administration

  • Directionsdo not take more than directedthe smallest effective dose should be usedAdults and children 12 years and older:take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours unless directed by a doctorChildren under 12 years:ask a doctor

Storage And Handling

  • Other informationStore between 20 to 25°C (68 to 77°F)Read all warnings and directions before usesave carton for complete drug facts information and warnings

Inactive Ingredient

Inactive ingredients collodial silicon dioide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Otc - Questions

Questions of comments? call 1-800-282-3000

Boxed Warning

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

* Please review the disclaimer below.