NDC 0924-0092 Physicians Care Allergy Plus

Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine Hcl 5mg

NDC Product Code 0924-0092

NDC Code: 0924-0092

Proprietary Name: Physicians Care Allergy Plus 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 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine Hcl 5mg 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;11
Score: 1

NDC Code Structure

  • 0924 - Acme United Corporation

NDC 0924-0092-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, FILM COATED in 1 PACKET (0924-0092-00)

NDC Product Information

Physicians Care Allergy Plus with NDC 0924-0092 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Allergy Plus is acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg. 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 Allergy Plus 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.

  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • ACETAMINOPHEN 325 mg/1
  • CHLORPHENIRAMINE MALEATE 2 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 12-23-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-01-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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]
Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)
Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[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]

* Please review the disclaimer below.

Physicians Care Allergy Plus Product Label Images

Physicians Care Allergy Plus 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 325 mgChlorpheniramine Maleate 2 mgPhenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains as s ociated withcommon coldheadachemuscular achesminor arthritis paincommon coldtoothachemenstrual crampsTemporarily relieves nasal congestion due tocommon coldhay fever or other respiratory allergiesTemporarilyreduces feverrelieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay feverpromotes nasal and/or sinus drainage; relieves sinus congestion and pressure

Warnings

  • Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:more than 12 tablets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug conntains acetaminophen, ask a doctor or pharmacist.for more than 10 days for pain unless directed by a doctorfor more than 3 days for fever unless directed by a doctorwith any other drug using the above active ingredientsif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’ disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking thisproduct.

Ask A Doctor Before Use If You Have

  • Liver disease thyroid diseasediabeteshigh blood pressureheart diseaseglaucomachronic bronchitis or emphysemadifficulty in urination due to enlargement of the prostate gland

When Using This Product

  • Drowsiness may occuravoid alcoholic beveragesalcohol, sedatives and tranquilizers may increase the drowsiness effectuse caution when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

Stop Use And Ask A Doctor If

  • Symptoms do not improve within 7 days or are accompanied by a feverpain or fever persists or gets worseredness or swelling is presentany new symptoms appear

Other

Do not exceed recommended dosage. If nervousness, dizziness or sleeplessness occurs, discontinue
use and consult a doctor.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of The Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medicalattention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not us e more than directedAdults and children: (12 years and older)Take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours.Children under 12 years :Do not give to children under 12 years of age.

Other Information

  • Store at room temperature 59º-86ºF (15º-30ºC)tamper-evident sealed packetsdo not use any opened or torn packetsavoid excessive heat and humidity

Inactive Ingredients

Corn starch, crospovidone*, hypromellose, maltodextrin*, microcrystalline cellulose, polyethyleneglycol, povidone, pregelatinized starch*, sodiun starch glycolate*, stearic acid*may contain

Physicians Care Allergy Plus

Physicians Care®Allergy PlusMulti-Symptom ReliefCOATED TABLETSTamper-Evident Packets of 2 tablets50 Packets (2 Tablets Each)

* Please review the disclaimer below.