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NDC 41250-0384-28 Cough DM 30 mg/5mL Details

Cough DM 30 mg/5mL

Cough DM is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

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: 41250-0384-28
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	41250-0384
Product ID	41250-384_40d7ea7b-9d73-4f4f-8628-ca0ac15dcf41
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cough DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan polistirex
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Meijer Distribution Inc
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	ANDA
Application Number	ANDA091135
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0384-28 (41250038428)

Pricing Information	N/A
NDC Package Code	41250-384-28
Billing NDC	41250038428
Package	1 BOTTLE in 1 CARTON (41250-384-28) / 148 mL in 1 BOTTLE
Marketing Start Date	2013-07-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fb6fce1e-2dea-485c-be18-c6764454fe25 Details

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

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.

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

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, 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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Delsym® Orange Flavor active ingredient

cough DM

Dextromethorphan Polistirex

Extended-Release Oral Suspension

Cough Suppressant

12 HOUR Cough Relief

Orange-Flavored Liquid

Day or Night

Alcohol Free

Dosing Cup Included

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

5 FL OZ (148 mL)

INGREDIENTS AND APPEARANCE

COUGH DM

dextromethorphan polistirex suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-384
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED (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)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-384-21	1 in 1 CARTON	08/27/2012	09/01/2016
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41250-384-28	1 in 1 CARTON	07/31/2013
2		148 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091135	08/27/2012

Labeler - Meijer Distribution Inc (006959555)

Revised: 6/2020

Document Id: 40d7ea7b-9d73-4f4f-8628-ca0ac15dcf41

Set id: fb6fce1e-2dea-485c-be18-c6764454fe25

Version: 5

Effective Time: 20200615