NDC 0924-0075 Physicians Care Ibuprofen

Ibuprofen 200mg

NDC Product Code 0924-0075

NDC Code: 0924-0075

Proprietary Name: Physicians Care 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 200mg 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)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;291
Score: 1

NDC Code Structure

NDC 0924-0075-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0075-00)

NDC 0924-0075-03

Package Description: 10 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0075-00)

NDC Product Information

Physicians Care Ibuprofen with NDC 0924-0075 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Ibuprofen is ibuprofen 200mg. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Acme United Corporation

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.

Physicians Care 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • LACTOSE (UNII: J2B2A4N98G)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

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: Acme United Corporation
Labeler Code: 0924
FDA Application Number: ANDA075010 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: 02-01-2016 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.

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.

Physicians Care Ibuprofen Product Label Images

Physicians Care 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

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with■ headache ■ toothache ■ backache ■ menstrual cramps■ common cold ■ muscular aches ■ minor arthritis painTemporarily reduces fever.

Allergy Alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms mayinclude:■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blistersIf an allergic reaction occurs, stop use and seek medical help right away.

Other

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher ifyou:■ are age 60 or older■ have had stomach ulcers or bleeding problems■ take a blood thinning (anticoagulant) or steroid drug■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, orothers)■ have 3 or more alcoholic drinks every day while using this product■ take more or for a longer time than directed

Do Not Use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer■ right before or after heart surgery

Ask A Doctor Before Use If

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

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin■ under a doctor’ care for any serious condition■ 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 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■ pain gets worse or lasts for more than 10 days■ fever gets worse or lasts for more than 3 days■ redness or swelling is present in the painful area■ any new or unexpected symptoms occur

If Pregnant Or Breast Feeding,

Ask a health professional before use. It is especially important not to use ibuprofen during the last 3months of pregnancy unless specifically directed to do so by a doctor because it may cause problems inthe 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 right away.

Directions


do not use 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 older)Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2tablets may be used.Do not exceed 6 tablets in 24 hours, unless directed by a doctor.Children under 12 years :Do not give to children under 12 years of age.

Other Information

■ read all product information before using■ store at 68-77° (20-25°)■ avoid excessive heat 40° (above 104°)■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredients

Carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*,microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*,silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide*may contain

Physicians Care Ibuprofen Label

Physicians Care®IbuprofenAnti-inflammatory, Fever Reducer & Pain Reliever (NSAID)Coated TabletsTamper-Evident Packets of 2 TabletsPill color may vary50 Packets (2 Tablets 200 Mg Each)

* Please review the disclaimer below.