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NDC 17856-0172-04 Delsym 30 mg/5mL Details
Delsym 30 mg/5mL
Delsym is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is DEXTROMETHORPHAN.
MedlinePlus Drug Summary
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 the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 17856-0172-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 17856-0172 |
|---|---|
| Product ID | 17856-0172_a4b63a00-f1e7-4954-98ad-b2b459e82ef1 |
| Associated GPIs | |
| GCN Sequence Number | 004630 |
| GCN Sequence Number Description | dextromethorphan polistirex SUS ER 12H 30 MG/5 ML ORAL |
| HIC3 | H6C |
| HIC3 Description | ANTITUSSIVES, NON-OPIOID |
| GCN | 17802 |
| HICL Sequence Number | 010295 |
| HICL Sequence Number Description | DEXTROMETHORPHAN POLISTIREX |
| Brand/Generic | Generic |
| Proprietary Name | Delsym |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DEXTROMETHORPHAN |
| Labeler Name | ATLANTIC BIOLOGICALS CORP. |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018658 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 17856-0172-04 (17856017204)
| NDC Package Code | 17856-0172-4 |
|---|---|
| Billing NDC | 17856017204 |
| Package | 1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-4) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) / 10 mL in 1 CUP, UNIT-DOSE |
| Marketing Start Date | 2022-09-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 00f8f5b4-f5a8-4dcf-8133-15964ad4801e Details
Active ingredient (in each 5 mL)
Uses
Warnings
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.
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)
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 a 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 |
Inactive ingredients
citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, 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
SPL UNCLASSIFIED SECTION
NDC 17856-0172-01Delsym® Dextromethorphan PolistirexExtended-Release Suspension (Cough Suppressant) COUGH 12HOURCOUGH RELIEF® GrapeFlavored Liquid 10mL CUP 72 PER CASE Day or NightSULFITE FREEALCOHOL FREE
INGREDIENTS AND APPEARANCE
| DELSYM
dextromethorphan suspension, extended release |
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| Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 047437707 | repack(17856-0172) | |