NDC 0924-0141 Physicians Care Cold Cough

Acetaminophen, Dextromethorphan Hydrbromide, Guaifenesin, Phenylephrine Hydrochloride

NDC Product Code 0924-0141

NDC Code: 0924-0141

Proprietary Name: Physicians Care Cold Cough 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, Dextromethorphan Hydrbromide, Guaifenesin, Phenylephrine Hydrochloride 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):
12 MM
Imprint(s):
FR;12
Score: 1

NDC Code Structure

NDC 0924-0141-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET in 1 PACKET

NDC 0924-0141-03

Package Description: 10 PACKET in 1 CARTON > 2 TABLET in 1 PACKET

NDC Product Information

Physicians Care Cold Cough with NDC 0924-0141 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Cold Cough is acetaminophen, dextromethorphan hydrbromide, guaifenesin, phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Acme United Corporation

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.

Physicians Care Cold Cough 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.

  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 15 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.

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

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: 05-13-2013 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]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[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 Cold Cough Product Label Images

Physicians Care Cold Cough 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 mgDextromethorphan Hydrobromide 15 mgGuaifenesin 200 mgPhenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducerCough suppressantExpectorantNasal decongestant

Uses

Temporarily relieves these cold symptoms■ cough■ sore throat■ minor aches and pains■ headache■ nasal congestion■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productiveTemporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening■ blisters■ rashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.
■ If you have ever had an allergic reaction to this product or any of its ingredients■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,

psychiatric or emotional conditions, or Parkinson's 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 this

product.

Ask A Doctor Before Use If You Have

■ liver disease■ heart disease■ high blood pressure■ thyroid disease■ diabetes■ trouble urinating due to an enlarged prostate gland■ cough that occurs with too much phlegm (mucus)■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist If You Are

■ taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

■ new symptoms occur■ redness or swelling is present■ pain or nasal congestion gets worse or lasts for more than 7 days■ fever gets worse or lasts for more than 3 days■ you get nervous, dizzy or sleepless■ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental 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 you do not notice any signs or symptoms.

Directions

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

Other Information

■ store at room temperature 59º-86ºF (15º-30ºC)■ avoid excessive heat and humidity■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredients

Maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Physicians Care Cold & Cough Label

Physicians Care®Non-DrowsyCold & CoughCold, Cough and Flu ReliefPull To OpenTamper-Evident Packets of 2 Tablets50 PACKETS (2Tablets Each)

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