NDC 0924-0134 Physicians Care Sinus

Phenykephrine Hcl 10mg

NDC Product Code 0924-0134

NDC Code: 0924-0134

Proprietary Name: Physicians Care Sinus 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: Phenykephrine Hcl 10mg 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
T;2;3;4
Score: 1

NDC Code Structure

NDC 0924-0134-01

Package Description: 50 PACKET in 1 CARTON > 1 TABLET, COATED in 1 PACKET (0924-0134-00)

NDC 0924-0134-03

Package Description: 10 PACKET in 1 CARTON > 1 TABLET, COATED in 1 PACKET (0924-0134-00)

NDC Product Information

Physicians Care Sinus with NDC 0924-0134 is a a human over the counter drug product labeled by Acme United. The generic name of Physicians Care Sinus is phenykephrine hcl 10mg. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Acme United

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 Sinus 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 10 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)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • 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
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: 06-02-2015 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: 09-01-2020 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’.

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Information for Patients

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]

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Physicians Care Sinus Product Label Images

Physicians Care Sinus 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 ingredient (in each tablet) Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

Temporarily relieves■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies■ sinus congestion and pressurePromotes nasal and/or sinus drainage.

Warnings

Warnings

Do Not Use

■ 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

■ heart disease■ high blood pressure■ thyroid disease■ diabetes■ trouble urinating due to an enlarged prostate gland

When Using This Product

■ do not exceed recommended dosage

Stop Use And Ask A Doctor If

■ you get nervous, dizzy or sleepless■ symptoms do not improve within 7 days or are accompanied by fever

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

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 directedAdults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.
Children under 12 years: Do not give to children under 12 years of age

Other Information

■ read all product information before using■ store at room temperature 59º-86º F (15º-30º C)■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredients

Carnauba wax*, croscarmellose sodium, dicalcium phosphate*, FD&C red #40, FD&C yellow # 6, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol*, silicon dioxide*, stearic acid*, titanium dioxide*may contain

Physicians Care Sinus Label

Physicians Care®Non Drowsy SinusDecongestant Clears Sinus Pressure & CongestionPull To OpenCoated TabletsTamper-Evident Packets of 1 Tablet50 Packets (1Tablet 10 Mg Each)

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