NDC 53943-508 Night-time Cough Relief

Dextromethorphan Hydrobromide, Doxylamine Succinate

NDC Product Code 53943-508

NDC 53943-508-28

Package Description: 354 mL in 1 BOTTLE

NDC Product Information

Night-time Cough Relief with NDC 53943-508 is a a human over the counter drug product labeled by Discount Drug Mart. The generic name of Night-time Cough Relief is dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Discount Drug Mart

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Night-time Cough Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
  • DOXYLAMINE SUCCINATE 12.5 mg/30mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)

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: 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: 10-27-2014 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: 12-31-2021 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

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]

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Night-time Cough Relief Product Label Images

Night-time Cough 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

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)

Dextromethorphan HBr 30 mgDoxylamine Succinate 12.5 mg

Purpose

Cough suppressantAntihistamine

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

  • Temporarily relieves cold symptoms:runny nose and sneezingcough

Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKENFailure to follow these warnings could result in serious consequences.

Do Not Use

  • If you are now taking a prescription monamine 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.to make a child sleepy

Ask A Doctor Befor Use If You Have

  • A sodium restricted dietglaucomacough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysematrouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use

  • If you are taking sedatives or tranquilizers

When Using This Product

  • Do not use more than directedavoid alcoholic drinksexcitability may occur, especially in childrenmarked drowsiness may occurbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

Ask a health professionalbefore use.

Directions

  • Use dose cup or tablespoon (TBSP)do not exceed 4 doses per 24 hoursWhen using Day Time and Night Time products, carefully read each label to ensure adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Other Information

  • Each 30 mL dose cup contains: sodium 45 mgstore at room temperature

Inactive Ingredients

Citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions ?

Call weekdays from 9:30 am to 4:30 pm EST.1-877-798-5944.

Discount Drug Martfood Faircherrynight-Timecough Refief Product Label

  • *COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGHDISCOUNTdrug martFOOD FAIRCherryNight-TimeCOUGH RELIEFDextromethorphan HBr ..... Cough SuppressantDoxylamine Succiate ......... AntihistamineCoughSneezingRunny Nose12 FL OZ (354 mL)* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® CoughLR-067SATISFACTION GUARANTEEDIF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

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