NDC 69842-852 Daytime Nighttime Cold Flu Relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 69842-852

NDC Code: 69842-852

Proprietary Name: Daytime Nighttime Cold Flu 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 Hbr, Doxylamine Succinate, 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.

NDC Code Structure

NDC 69842-852-24

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 * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK

NDC 69842-852-48

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 * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON > 1 CAPSULE in 1 BLISTER PACK

NDC Product Information

Daytime Nighttime Cold Flu Relief with NDC 69842-852 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Daytime Nighttime Cold Flu Relief is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. 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 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)
  • MANNITOL (UNII: 3OWL53L36A)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • 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)
  • MANNITOL (UNII: 3OWL53L36A)

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: 06-01-2019 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.

Daytime Nighttime Cold Flu 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

Active Ingredients For Daytime (In Each Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Active Ingredients For Nighttime (In Each Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose For Daytime

Pain reliever/fever reducerCough suppressantNasal decongestant

Purpose For Nighttime

Pain reliever/fever reducerCough suppressantAntihistamine

Uses

  • DAYTIMEtemporarily relieves common cold and flu symptomscough due to minor throat and bronchial irritation nasal congestionheadacheminor aches and pains feversore throatNIGHTTIMEtemporarily relieves common cold and flu symptomscough due to minor throat and bronchial irritationsore throat headacheminor aches and pains fever runny nose and sneezing

Warnings

  • DAYTIMELiver 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 these productsAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddening
  • Blisters
  • RashIf 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.NIGHTTIMELiver warning: This product 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 productAlergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening
  • Blisters
  • RashIf 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 following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Do Not Use

  • DAYTIMEwith 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. 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 disease
  • Heart disease
  • Diabetes
  • Thyroid disease
  • High blood pressure
  • Cough that occurs with too much phlegm (mucus)
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysemaNIGHTTIMEliver disease
  • Glaucoma
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • DAYTIME taking the blood thinning drug warfarinNIGHTTIMEtaking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

When Using This Product,

  • DAYTIMEdo not exceed recommended dosageNIGHTTIMEdo not exceed recommended dosageexcitability may occur, especially in children
  • Marked 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

  • DAYTIMEnervousness, dizziness or sleeplessness occur
  • Pain, cough, and nasal congestion gets worse or lasts more than 7 days
  • Redness or swelling is present
  • New symptoms occur
  • Fever gets worse or lasts more than 3 days
  • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.NIGHTTIMEpain or cough gets worse or lasts more than 7 days
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present
  • New symptoms occur
  • Cough comes back or occurs with rash headache that lasts. These could be a signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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.

Directions

  • DAYTIME do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours
  • Swallow whole; do not crush, chew, or dissolve
  • Adults and children 12 years and over; take 2 softgels with water every 4 hours.
  • Children under 12 years: do not useNIGHTTIMEdo not take more than directed (see Overdose warning)do not take more than 4 doses in 24 hours
  • Swallow whole; do not crush, chew, or dissolve
  • Adults and children 12 years and over: take 2 softgels with water every 6 hours
  • Children under 12 years: do not use

Other Information

  • Store between 15-30°C (59-86°F)
  • Avoid excessive heat

Inactive Ingredients

DAYTIMEbutylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white inkNIGHTTIMED&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan*, sorbitol, white ink

Product Label

CVS HEALTH Daytime Nighttime Multi-Symptom Cold/Flu Relief

* Please review the disclaimer below.