NDC 69842-629 Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

NDC Product Code 69842-629

NDC CODE: 69842-629

Proprietary Name: Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief 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 Hydrobromide, Doxylamine Succinate, 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.

NDC Code Structure

  • 69842 - Cvs Pharmacy, Inc.
    • 69842-629 - Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief

NDC 69842-629-20

Package Description: 1 KIT in 1 CARTON * 1 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief with NDC 69842-629 is a a human over the counter drug product labeled by Cvs Pharmacy, Inc.. The generic name of Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. The product's dosage form is kit and is administered via oral form.

Labeler Name: Cvs Pharmacy, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.
  • 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: Cvs Pharmacy, Inc.
Labeler Code: 69842
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: 02-11-2020 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: 12-31-2021 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.

Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief Product Label Images

Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief 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

Non Drowsy Daytime Sinus Congestion And Cough Relief Active Ingredients (In Each Softgel)

Acetaminophen 325 mg  Dextromethorphan hydrobromide 10 mg


Phenylephrine hydrochloride 5 mg

Nighttime Sinus Congestion And Cough Relief Active Ingredients (In Each Softgel)

Acetaminophen 325 mg








Dextromethorphan hydrobromide 10 mg








Doxylamine succinate 6.25 mg








Phenylephrine hydrochloride 5 mg

Purposes

Non Drowsy DAYTIME Sinus Congestion and Cough ReliefPain reliever/fever reducerCough suppressantNasal decongestant

Nighttime Sinus Congestion and Cough ReliefPain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Uses

  • Non Drowsy DAYTIME Sinus Congestion and Cough Relieftemporarily relieves these symptoms due to a cold or flu:
  • Minor aches and painsheadachecoughsore throatnasal and sinus congestiontemporarily reduces fever

  • NIghttime Sinus Congestion and Cough Relieftemporarily relieves these symptoms due to a cold or flu:
  • Minor aches and painsheadachenasal and sinus congestioncoughsore throatrunny nosesneezingtemporarily reduces fever

Non Drowsy Daytime Sinus Congestion And Cough Relief Warnings

  • Liver warningThese products contain acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of Acetaminophen in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productSore throat warningIf 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.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrash
  • If 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 ingredientsin children under 12 years of age

  • 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 ingredientsin children under 12 years of age

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetescough with excessive phlegm (mucus)difficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetesglaucoma cough with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysema

Otc - When Using

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • Pain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.      These could be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

  • Pain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lasts.      These could be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

Keep Out Of Reach Of Children.

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

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

Nighttime  Sinus Congestion And Cough Relief Warnings

  • Liver warningThese products contain acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of Acetaminophen in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productSore throat warningIf 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.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrash
  • If a skin reaction occurs, stop use and seek medical help right away.Do not use to sedate children.

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Do not exceed recommended dosage may cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Non Drowsy Daytime Sinus Congestion And Cough Relief Directions

  • Do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use

Nighttime Sinus Congestion And Cough Relief Directions

  • Do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use

Non Drowsy Daytime Sinus Congestion And Cough Relief Other Information

  • Store at room temperature. Avoid excessive heat.

Nighttime Sinus Congestion And Cough Relief Other Information

  • Store at room temperature. Avoid excessive heat.

Non Drowsy Daytime Sinus Congestion And Cough Relief Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene








glycol-400, povidone, propylene glycol, purified water, sorbitol sorbitan,








titanium dioxide

Nighttime Sinus Congestion And Cough Relief Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene








glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol








sorbitan, sodium hydroxide, titanium dioxide

Non Drowsy Daytime Sinus Congestion And Cough Relief

Questions or comments?1-888-333-9792

Nighttime Sinus Congestion And Cough Relief

Questions or comments?1-888-333-9792

* Please review the disclaimer below.