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NDC 54738-0985-30 Mucus Relief Cough and Congestion DM 20; 400 mg/1; mg/1 Details

Mucus Relief Cough and Congestion DM 20; 400 mg/1; mg/1

Mucus Relief Cough and Congestion DM is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

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: 54738-0985-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 54738-0985-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	54738-0985
Product ID	54738-985_5cc409a8-23e1-738f-e053-2a91aa0ac0d5
Associated GPIs	43997002520345
GCN Sequence Number	058386
GCN Sequence Number Description	guaifenesin/dextromethorphan TABLET 400MG-20MG ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	23807
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Mucus Relief Cough and Congestion DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Dextromethorphan HBr
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	20; 400
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Richmond Pharmaceuticals, 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	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54738-0985-30 (54738098530)

Pricing Information	N/A
NDC Package Code	54738-985-30
Billing NDC	54738098530
Package	30 TABLET in 1 BOTTLE (54738-985-30)
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59b00858-e5c9-420a-bc7e-46953722cde6 Details

Active ingredients (in each caplet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

do not use more than directed.

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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.

Directions

take with a full glass of water
adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Questions or comments?

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

Mucus Relief Cough and Congestion DM

NDC- 54738-985-30....30 caplets

NDC- 54738-985-60....60 caplets

INGREDIENTS AND APPEARANCE

MUCUS RELIEF COUGH AND CONGESTION DM

guaifenesin and dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-985
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AP;150
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-985-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016
2	NDC:54738-985-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/01/2016

Labeler - Richmond Pharmaceuticals, Inc (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-985)

Revised: 10/2017

Document Id: 5cc409a8-23e1-738f-e053-2a91aa0ac0d5

Set id: 59b00858-e5c9-420a-bc7e-46953722cde6

Version: 2

Effective Time: 20171030