NDC 69842-908 Daytime Nighttime Sinus Relief Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl, Guaifenesin

NDC Product Code 69842-908

NDC CODE: 69842-908

Proprietary Name: Daytime Nighttime Sinus Relief Maximum Strength 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 Hbr, Doxylamine Succinate, Phenylephrine Hcl, Guaifenesin 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

NDC 69842-908-24

Package Description: 1 KIT in 1 KIT * 8 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK

NDC Product Information

Daytime Nighttime Sinus Relief Maximum Strength with NDC 69842-908 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Daytime Nighttime Sinus Relief Maximum Strength is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, guaifenesin. The product's dosage form is kit and is administered via oral form.

Labeler Name: Cvs Pharmacy

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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MANNITOL (UNII: 3OWL53L36A)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MANNITOL (UNII: 3OWL53L36A)

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
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: 10-30-2019 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]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[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.

Daytime Nighttime Sinus Relief Maximum Strength Product Label Images

Daytime Nighttime Sinus Relief Maximum Strength 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 Daytime (In Each Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mgPhenylephrine HCl 5 mg

Active Ingredients In Nighttime (In Each Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mgPhenylephrine HCI 5 mg

Purpose For Daytime

Pain relieverCough suppressantExpectorantNasal decongestant

Purpose For Nighttime

Pain relieverCough suppressantAntihistamineNasal decongestant

Uses

  • DAYTIMEtemporarily relievesnasal congestionheadachecough sinus congestion and pressureminor aches and painstemporarily promotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productiveNIGHTTIMEtemporarily relievesnasal congestioncough headachesinus congestion and pressureminor aches and painsrunny nose and sneezingtemporarily promotes nasal and/or sinus drainage

Warnings

  • DAYTIME and NIGHTTIMELiver warning: These products contain 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 reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away

Do Not Use

  • DAYTIME and NIGHTTIMEwith 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.

Ask A Doctor Before Use If You Have

  • DAYTIMEliver diseasehigh blood pressurediabetesheart diseasethyroid diseasetrouble urinating due to an enlarged prostate glanda persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)NIGHTTIMEliver diseasehigh blood pressurediabetesheart diseasethyroid diseaseglaucomatrouble urinating due to an enlarged prostate glandbreathing problem s such as emphysema or chronic bronchitispersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • DAYTIMEtaking the blood thinning drug warfarinNIGHTTIMEtaking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product,

  • DAYTIMEdo not use more than directedNIGHTTIMEdo not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • DAYTIME and NIGHTTIMEnervousness, 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 occurcough comes back or occurs with rash or headache that lasts. These coukld be signs of a serious condition.

If Pregnant Or Breast-Feeding,

DAYTIME and NIGHTTIMEask a health professional before use.

Keep Out Of Reach Of Children.

DAYTIME and NIGHTTIMEOverdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • DAYTIMEdo not take more than directed (see Overdose warning)do not take more than 12 softgels in any 24-hour periodadults and children 12 years of age and older: take 2 softgels every 4 hourschildren under 12 years of age: do not usewhen using other Daytime or Nighttime products, carefully read each label to ensure correct dosingNIGHTTIMEdo not take more than directed (see Overdose warning)do not take more than 12 softgels in any 24-hour periodadults and children 12 years of age and older: take 2 softgels every 4 hourschildren under 12 years of age: do not usewhen using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other Information

  • DAYTIME and NIGHTTIMEswallow whole; do not crush, chew, or dissolvestore between 15-30ºC (59-86F)avoid excessive heat

Inactive Ingredients

DAYTIME FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxideNIGHTTIMED&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Product Label

CVS HEALTH Maximum Strength Daytime Nighttime Sinus Relief

* Please review the disclaimer below.