NDC 67510-0503 Night Time Cough

NDC Product Code 67510-0503

NDC 67510-0503-1

Package Description: 295 mL in 1 BOTTLE

NDC 67510-0503-2

Package Description: 354 mL in 1 BOTTLE

NDC 67510-0503-4

Package Description: 120 mL in 1 BOTTLE

NDC 67510-0503-6

Package Description: 177 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Night Time Cough with NDC 67510-0503 is a product labeled by Kareway Product, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1234386.

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

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

Labeler Name: Kareway Product, Inc.
Labeler Code: 67510
Start Marketing Date: 07-11-2012 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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]

* Please review the disclaimer below.

Night Time Cough Product Label Images

Night Time Cough 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 30 Ml Dose Cup)

Dextromethorphan HBr 30 mgDoxylamine succinate 12.5 mg

Purpose

Cough suppressantAntihistamine

Uses

  • Temporarily relieves common cold symptoms:coughrunny nose and sneezing

Do Not Use

  • 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.to make a child sleep

Ask A Doctor Before Use If You Have

  • Glaucomaexcessive 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 glanda sodium-restricted diet

When Using This Product

  • Do not use more than directedexcitability may occur, especially in children.marked drowsiness may occuravoid alcoholic drinksbe 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 is accompanied by fever, rash, or persistent headache. 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Use dose cup or tablespoon (TBSP)do not exceed 4 doses per 24 hoursadults and children 12 years and over2 TBSP (30ml) every 6 hourschildren under 12 yearsask a doctor

Other Information

  • Each 30mL dose cup contains: sodium 36 mgstore at room temperature

Inactive Ingredients

Alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum

Package Label

Night Time Cough Relief

* Please review the disclaimer below.