NDC 65923-633 Family Care Cough And Cold

NDC Product Code 65923-633

NDC 65923-633-04

Package Description: 118 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

Family Care Cough And Cold with NDC 65923-633 is a product labeled by United Exchange Corp.. The generic name of Family Care Cough And Cold is . The product's dosage form is and is administered via form.

Labeler Name: United Exchange Corp.

Dosage Form: -

Product Type: 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

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

Labeler Name: United Exchange Corp.
Labeler Code: 65923
Start Marketing Date: 07-29-2015 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: 12-31-2018 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 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.

Family Care Cough And Cold Product Label Images

Family Care Cough And Cold 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 10 mL)                                                               PurposeDextromethorphan HBr, USP 20 mg............................................Cough suppressantGuaifenesin, USP 200 mg....................................................................Expectorant

Otc - Purpose

  • Usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldhelps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.

Warnings

WarningsDo 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 until 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 havecough that occurs with too much phlegm (mucus)or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Otc - Stop Use

  • Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Directionsdo not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provided. Keep dosing cup with productmL = milliliterthis adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

Storage And Handling

  • Other informationeach 10 mL contains: sodium 3 mgStore at 20° to 25°C (68° to 77°F). Do not refrigerate.

Inactive Ingredient

Inactive ingredientscitric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

Dosage & Administration

Distributed by:United Exchange Corp.17211 Valley View Ave.Cerritos, CA 90703 USAMade in Korea

* Please review the disclaimer below.