NDC 0924-0130 Physicians Care Extra Strength Pain Reliever

Acetaminophen, Aspirin, Caffeine

NDC Product Code 0924-0130

NDC Code: 0924-0130

Proprietary Name: Physicians Care Extra Strength Pain Reliever 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: Acetaminophen, Aspirin, Caffeine 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
FR;9
Score: 1

NDC Code Structure

  • 0924 - Acme United Corporation
    • 0924-0130 - Physicians Care Extra Strength Pain Reliever

NDC 0924-0130-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, FILM COATED in 1 PACKET

NDC Product Information

Physicians Care Extra Strength Pain Reliever with NDC 0924-0130 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Extra Strength Pain Reliever is acetaminophen, aspirin, caffeine. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Acme United Corporation

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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 Extra Strength Pain Reliever 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.

  • ASPIRIN 250 mg/1
  • ACETAMINOPHEN 250 mg/1
  • CAFFEINE 65 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • 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: Acme United Corporation
Labeler Code: 0924
FDA Application Number: part343 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-27-2013 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

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Aspirin

Aspirin is pronounced as (as' pir in)
Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Physicians Care Extra Strength Pain Reliever Product Label Images

Physicians Care Extra Strength Pain Reliever 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 ingredients (in each tablet)Acetaminophen 250 mgAspirin (NSAID*) 250 mgCaffeine 65 mg*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducerPain reliever/fever reducerPain reliever aid

Uses

  • For the temporary relief of minor aches and pauns associated withheadachemuscular achesminor arthritis painback paincommon coldtoothachemenstrual crampsTemporarily reduces fever.

Warnings

  • Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
  • Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
  • ■ hives ■ facial swelling ■ asthma (wheezing) ■ shockAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • ■ skin reddening ■ blisters ■ rashIf a skin or allergic reaction occurs, stop use and seek medical help right away.Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 4,0000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains an 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 directedCaffeine warning: The recommended dose of th
  • Is product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
  • Acetaminophen, ask a doctor or pharmacist.
  • For pain for more than 10 days unless directed by a doctorfor more than 3 days for fever unless directed by a doctorif you ever have had an allergic reaction to any other pain relievers/ fever reducersright before or after heart surgeryif you are taking prescription drugs for gout, diabetes, or arthritis

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have a history of stomach problems such as heartburnyou have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarinunder a doctor's care for any serious conditiontaking 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 bettersymptoms do not improvepain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysringing in the ears or loss of hearing occursredness or swelling is present in the painful areaany new symptoms appear

If Pregnant Or Breast Feeding,

Ask a health care professional before use. It is especially important not to use aspirin 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 right away. Prompt medical attention is critical for adults as well as for children even if do not notice any signs or symptoms.

Directions

  • Do not use more than directedAdults and children: (12 years and older)Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.Children under 12 years:Do not give to children under 12 years of age.

Other Information

  • Read all product information before usingstore at room temperature 59°-86°F (15°-30°C)avoid excessive heat and humiditytamper evident sealed packetsdo not use any opened or torn packets

Inactive Ingredients

Hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Physicians Care Xs Pain Reliever Label

Physicians Care®Exra SrengthPain ReliverAcetaminophen, Aspirin (NSAID) and CaffeinePain Reliever / Pain Reliever AidCoated TabletsTamper-Evident Packets of 2 Tablets100 Tablets (50 Packets, 2 each)

* Please review the disclaimer below.