NDC 53943-669 Cold And Flu Relief Multi-symptom

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

NDC Product Code 53943-669

NDC CODE: 53943-669

Proprietary Name: Cold And Flu Relief Multi-symptom 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

  • 53943 - Discount Drug Mart

NDC 53943-669-09

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Cold And Flu Relief Multi-symptom with NDC 53943-669 is a a human over the counter drug product labeled by Discount Drug Mart. The generic name of Cold And Flu Relief Multi-symptom is acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl. The product's dosage form is kit and is administered via form.

Labeler Name: Discount Drug Mart

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, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Discount Drug Mart
Labeler Code: 53943
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: 12-02-2019 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.

Cold And Flu Relief Multi-symptom Product Label Images

Cold And Flu Relief Multi-symptom 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 Each Liquid-Filled Capsule) (Daytime Cold & Flu)

Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducerCough suppressantNasal decongestant

Pain reliever/fever reducerCough suppressantAntihistamine

Active Ingredients (In Each Liquid-Filled Capsule) (Nighttime Cold & Flu)

Acetaminophen 325 mgDextromethorphan HBr 15 mgDoxylamine succinate 6.25 mg

Uses

  • Temporarily relieves common cold and flu symptoms:feverheadachesore throatminor aches and painscough due to minor throat and bronchial irritationnasal congestion (Daytime only)runny nose and sneezing (Nighttime only)

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 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.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.

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 ingredientsto make a child sleepy (Nighttime only)

Ask A Doctor Before Use If You Have

  • Cough that occurs with too much phlegm (mucus)difficulty in urination due to enlargement of the prostate glandliver diseasediabetes (Daytime only)heart disease (Daytime only)thyroid disease (Daytime only)high blood pressure (Daytime only)persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)glaucoma (Nighttime only)

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers (Nighttime only)

When Using This Product

  • Do not exceed recommended dosagemarked drowsiness may occur (Nighttime only)avoid alcoholic beverages (Nighttime only)excitability may occur, especially in children (Nighttime only)use caution when driving a motor vehicle or operating machinery (Nighttime only)alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occur (Daytime only)pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)pain or cough gets worse or lasts more than 7 days (Nighttime only)fever 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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Directions (Daytime Only)

  • Do not take more than directeddo not take more than 8 capsules per 24 hoursadults and children 12 years and over: take 2 capsules with water every 4 hourschildren under 12 years: ask a doctor

Directions (Nighttime Only)

  • Do not take more than directeddo not take more than 8 capsules per 24 hoursadults and children 12 years and over: take 2 capsules with water every 6 hourschildren under 12 years: ask a doctorDo not take more than 8 capsules of Daytime and Nighttime products in any 24-hour period.

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)protect from heat, humidity and lightsee end flap for expiration date and lot number

Inactive Ingredients (Daytime Only)

Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Inactive Ingredients (Nighttime Only)

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

* Please review the disclaimer below.