NDC 0113-7384 Basic Care Cough Dm
Dextromethorphan Polistirex Suspension Oral
Product Information
What is NDC 0113-7384?
The NDC code 0113-7384 is assigned by the FDA to the product Basic Care Cough Dm which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Cough Dm is dextromethorphan polistirex. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-7384-28 1 bottle in 1 carton / 148 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Basic Care Cough Dm?
This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
Product Characteristics
Color(s) | ORANGE (C48331) |
Flavor(s) | ORANGE (C73406) |
Product Packages
NDC Code 0113-7384-28
Package Description: 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE
Product Details
What are Basic Care Cough Dm Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
Basic Care Cough Dm Active Ingredients UNII Codes
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
- RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
- RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
- RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension
Basic Care Cough Dm Inactive Ingredients UNII Codes
- POLISTIREX (UNII: 5H9W9GTW27)
- D&C RED NO. 30 (UNII: 2S42T2808B)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- GLYCERIN (UNII: PDC6A3C0OX)
- HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POLYVINYL ACETATE (UNII: 32K497ZK2U)
- POVIDONE (UNII: FZ989GH94E)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- WATER (UNII: 059QF0KO0R)
- SODIUM METABISULFITE (UNII: 4VON5FNS3C)
- SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
- SUCROSE (UNII: C151H8M554)
- TARTARIC ACID (UNII: W4888I119H)
- TRAGACANTH (UNII: 2944357O2O)
- TRIACETIN (UNII: XHX3C3X673)
- XANTHAN GUM (UNII: TTV12P4NEE)
Pharmacologic Class(es)
* Please review the disclaimer below.
Basic Care Cough Dm Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Active Ingredient (In Each 5 Ml)
Dextromethorphan polistirex equivalent to 30 mg
dextromethorphan hydrobromide
Purpose
Cough suppressant
Uses
temporarily relieves
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants• the impulse to cough to help you get to sleep
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.
Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Ask A Doctor Before Use If You Have
• chronic cough that lasts as occurs with smoking, asthma or emphysema• cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.• 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.
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 (1-800-222-1222).
Directions
• shake bottle well before use• measure only with dosing cup provided• do not use dosing cup with other products• dose as follows or as directed by doctor• mL = milliliter
adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
children under 4 years of age | do not use |
Other Information
• each 5 mL contains: sodium 5 mg• store at 20° to 25°C (68° to 77°F)• dosing cup provided
Inactive Ingredients
D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Day or Night
Compare to Delsym®
active ingredient
cough DM
Dextromethorphan Polistirex Extended-Release Oral Suspension
Cough Suppressant
12 Hour Cough Relief
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions
Orange-Flavored Liquid
Dosing Cup Included
Alcohol-free
5 FL OZ (148 mL)
* Please review the disclaimer below.