NDC 69842-451 Maximum Strength Daytime Nighttime Cold And Flu

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

NDC Product Code 69842-451

NDC CODE: 69842-451

Proprietary Name: Maximum Strength Daytime Nighttime Cold And Flu 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, Guaifenesin, Phenylephrine Hcl 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.

Product Characteristics

Color(s):
GREEN (C48329)
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
20 MM
24 MM
Imprint(s):
72
78
Score: 1

NDC Code Structure

  • 69842 - Cvs Pharmacy, Inc.
    • 69842-451 - Maximum Strength Daytime Nighttime Cold And Flu

NDC 69842-451-24

Package Description: 1 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-382-08) * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-094-16)

NDC Product Information

Maximum Strength Daytime Nighttime Cold And Flu with NDC 69842-451 is a a human over the counter drug product labeled by Cvs Pharmacy, Inc.. The generic name of Maximum Strength Daytime Nighttime Cold And Flu is acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SHELLAC (UNII: 46N107B71O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POVIDONE (UNII: FZ989GH94E)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SORBITOL (UNII: 506T60A25R)
  • SHELLAC (UNII: 46N107B71O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: 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: 05-31-2021 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.

Maximum Strength Daytime Nighttime Cold And Flu Product Label Images

Maximum Strength Daytime Nighttime Cold And Flu 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

Otc - Active Ingredient

Active ingredients (in each softgel)Daytime Cold & Flu
Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg
Active ingredients (in each softgel)

Nighttime Cold & Flu

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Otc - Purpose

PurposesDaytime Cold & FluPain reliever/fever reducerCough suppressant

Expectorant

Nasal decongestant
Purposes
Nighttime Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Nasal decongestant

Indications & Usage

  • Usestemporarily relieves these common cold and flu symptoms:sinus congestion and pressure
  • Cough
  • Minor aches and pains
  • Headache
  • Nasal congestion
  • Sore throat
  • Runny nose and sneezing (
  • Nighttime only)
  • Itchy, watery eyes due to hay fever (
  • Nighttime only)
  • Itching of the nose or throat (
  • Nighttime only)
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (
  • Daytime only)
  • Controls cough to help you get to sleeptemporarily reduces fever

Warnings

  • WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 12 softgels in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks daily 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.
  • Sore 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.

Otc - Do Not Use

  • Do not usewith 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver diseaseheart diseasediabeteshigh blood pressurethyroid diseasetrouble urinating due to an enlarged prostate glandglaucoma (
  • Nighttime only)
  • Breathing problems such as emphysema or chronic bronchitis (
  • Nighttime only)
  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers (
  • Nighttime only)

Otc - When Using

  • When using this productdo not use more than directedexcitability may occur, especially in children (
  • Nighttime only)
  • Marked drowsiness may occur (
  • Nighttime only)
  • Alcohol, sedatives, and tranquilizers may increase drowsiness (
  • Nighttime only)
  • Avoid alcoholic drinks (
  • Nighttime only)
  • Be careful when driving a motor vehicle or operating machinery (
  • Nighttime only)

Otc - Stop Use

  • Stop use and ask a doctor ifnervousness, 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 fever, rash, or headache that lasts.These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsdo 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 over: take 2 softgels every 4 hourschildren under 12 years of age: do not use

Other Information

  • Other informationstore at 20-25°C (68-77°F)avoid excessive heat

Inactive Ingredient

Inactive ingredients (Daytime only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water
Inactive ingredients (Nighttime only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

Otc - Questions

Questions? call 1-877-290-4008

* Please review the disclaimer below.