NDC 68210-4164 Non-drowsy Daytime Severe Sinus Congestion And Pain

Acetaminophen, Guaifenesin And Phenylephrine Hcl

NDC Product Code 68210-4164

NDC CODE: 68210-4164

Proprietary Name: Non-drowsy Daytime Severe Sinus Congestion And Pain 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, Guaifenesin And Phenylephrine Hcl 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 - WHITE TO OFF WHITE)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
S503
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc
    • 68210-4164 - Non-drowsy Daytime Severe Sinus Congestion And Pain

NDC 68210-4164-1

Package Description: 1 BOTTLE in 1 CARTON > 12 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Non-drowsy Daytime Severe Sinus Congestion And Pain with NDC 68210-4164 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Non-drowsy Daytime Severe Sinus Congestion And Pain is acetaminophen, guaifenesin and phenylephrine hcl. The product's dosage form is tablet, film coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1243679.

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.

Non-drowsy Daytime Severe Sinus Congestion And Pain 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.


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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • TALC (UNII: 7SEV7J4R1U)
  • 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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
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: 06-23-2021 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".

* 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]
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.

Non-drowsy Daytime Severe Sinus Congestion And Pain Product Label Images

Non-drowsy Daytime Severe Sinus Congestion And Pain 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

Active Ingredients (In Each Caplet)

Acetaminophen 325 mg


Guaifenesin 200 mg


Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer


Expectorant


Nasal decongestant

Uses

  • Temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:headachenasal congestionminor aches and painssinus congestion and pressurehelps 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 acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Blisters rashskin reddeningIf 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 contains acetaminophen, ask a doctor or pharmacist. 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.if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • Cough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema heart diseasethyroid diseasediabetesliver diseasehigh blood pressuredifficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occur
  • 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 (1-800-222-1222) 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

  • Do not take more than directed
  • Adults and children 12 years and over
  • Take 2 caplets every 4 hoursswallow whole - do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

* Please review the disclaimer below.