NDC 42961-333 Sine-eez

Sinus Decongestant

NDC Product Code 42961-333

NDC 42961-333-02

Package Description: 2 TABLET in 1 PACKET

NDC Product Information

Sine-eez with NDC 42961-333 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Sine-eez is sinus decongestant. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas 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.

Sine-eez 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

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.

  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Cintas Corporation
Labeler Code: 42961
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: 11-29-2016 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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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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Sine-eez 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

Otc - Active Ingredient

Each tablet contains: Phenylephrine HCL 5mg

Otc - Purpose

Nasal Decongestant

Indications & Usage

Uses: temporarily relieves nasal congestion due to: common cold, hayfever or other upper respiratory allergies, stuffy nose

Warnings

FOR COMPLETE WARNINGS/CAUTIONS: SEE BOXWhen using this product do not exceed recommended dose.

Otc - Do Not Use

Do not use lf you are now taking a prescription monoamlne oxidase lnhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping MAOl drug .If you do not know if your prescription drug contains a MAOl, consult a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland

Otc - Stop Use

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur, symptoms do not improve within 7 days or are accompanied by fever, new symptoms occur.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Overdosage

In case of overdose, get medical help or contact Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use

Dosage & Administration

DIRECTIONS: Adults: 2 tablets every 4 hours as needed. Do not exceed 6 doses in a 24 hours. Children under 12 years: ask a doctor.

Other Safety Information

Store at room temperature. Avoid excess heat and humidity.PACKET NOT FOR INDIVIDUAL SALEDo not use if packet is open or torn.

* Please review the disclaimer below.