NDC 69842-720 Mucus Relief Daytime Severe Cold Nighttime Cold And Flu Maximum Strength

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

NDC Product Code 69842-720

NDC Code: 69842-720

Proprietary Name: Mucus Relief Daytime Severe Cold Nighttime Cold And Flu Maximum Strength Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 69842 - Cvs Pharmacy
    • 69842-720 - Mucus Relief Daytime Severe Cold Nighttime Cold And Flu

NDC 69842-720-24

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

Mucus Relief Daytime Severe Cold Nighttime Cold And Flu Maximum Strength with NDC 69842-720 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Mucus Relief Daytime Severe Cold Nighttime Cold And Flu Maximum Strength is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin. The product's dosage form is kit and is administered via form.

Labeler Name: Cvs Pharmacy

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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)

Product Labeler Information

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-30-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Mucus Relief Daytime Severe Cold Nighttime Cold And Flu Maximum Strength Product Label Images

Mucus Relief Daytime Severe Cold Nighttime Cold And Flu 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 reliever/fever reducerCough suppressantExpectorantNasal decongestant

Purpose For Nighttime

Pain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Uses

  • DAYTIMEtemporarily relieves these common cold and flu symptomsheadachenasal congestionsore throatcoughminor aches and painshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces feverNIGHTTIMEtemporarily relieves these common cold and flu symptomscoughheadacheminor aches and painssore throatnasal congestionrunny nose and sneezingcontrols cough to help you get to sleeptemporarily reduces fever

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 awaySore throat warning: If 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.

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 diseasediabeteshigh blood pressureheart 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 diseasediabeteshigh blood pressureheart diseaseglaucomathyroid diseasetrouble urinating due to an enlarged prostate glanda breathing problem or chronic cough that lasts or 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 sleeplessnesspain, 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 (Daytime and NightTime) 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 (Daytime and Nighttime) 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, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide*may contain this ingredientNIGHTTIMED&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide*contains one or more of these ingredients

Product Label

CVS HEALTH Maximum Strength Daytime Severe Cold Nighttime Cold & Flu

* Please review the disclaimer below.

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