MedPath

DG Health Cough DM

Dolgencorp, LLC Cough DM Drug Facts

Approved
Approval ID

2f22f1bd-3f8e-8a8f-e063-6294a90a8a24

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Sixarp, LLC

DUNS: 016329513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

dextromethorphan polistirex

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59368-264
Application NumberANDA091135
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextromethorphan polistirex
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (19)

POLISTIREXInactive
Code: 5H9W9GTW27
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/25/2020

Package/Label Principal Display Panel

Compare to the active ingredient of Delsym ®

Day or Night

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

12 HOUR COUGH RELIEF

Alcohol free

Gluten free

Dosing cup included

Orange-Flavored Liquid

3 FL OZ (89 mL)

cough dm inage

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/24/2013

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/25/2020

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/24/2013

Purpose

Cough suppressant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/25/2020

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.

**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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/25/2020

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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/25/2020

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

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/25/2020

Other information

***each 5 mL contains:**sodium 5 mg

  • store at 20° to 25°C (68° to 77°F)
  • dosing cup provided

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/25/2020

Inactive ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/25/2020

Questions or comments?

1-888-309-9030

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