NDC 17856-0276 Delsym (dextromethorphan)

NDC Product Code 17856-0276

NDC 17856-0276-1

Package Description: 10 mL in 1 CUP

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

NDC Product Information

Delsym (dextromethorphan) with NDC 17856-0276 is a product labeled by Atlantic Biologicals Corps. The generic name of Delsym (dextromethorphan) is . The product's dosage form is and is administered via form.

Labeler Name: Atlantic Biologicals Corps

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.

  • POLISTIREX (UNII: 5H9W9GTW27)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)
  • TRAGACANTH (UNII: 2944357O2O)
  • 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: Atlantic Biologicals Corps
Labeler Code: 17856
Start Marketing Date: 08-19-2011 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 - 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. Values = ‘Y’ or ‘N’.

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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...
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Delsym (dextromethorphan) Product Label Images

Delsym (dextromethorphan) 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 Ingredient (In Each 5 Ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

  • Temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe impulse to cough to help you get to sleep

Otc - 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.
Do not use

Ask A Doctor Before Use If You Have

  • Chronic cough that lasts as occurs with smoking, asthma or emphysemacough that occurs with too much phlegm (mucus)

Otc - Stop Use

Cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
Stop use and ask a doctor if

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children.

Directions

  • Shake bottle well before usemeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctormL = milliliteradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use

Other Information

  • Each 5 mL contains:
  • Sodium 7 mgstore at 20-25°C (68-77°F)dosing cup provided

Inactive Ingredients

Citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

1-888-963-3382You may also report side effects to this phone number.

Other

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224

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