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NDC 17714-0150-60 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 Advance Pharmaceutical 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: 17714-0150-60
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: 17714-0150-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	17714-0150
Product ID	17714-150_5cc973b8-e550-2f6c-e053-2a91aa0a9ab8
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	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	Advance Pharmaceutical 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 17714-0150-60 (17714015060)

Pricing Information	N/A
NDC Package Code	17714-150-60
Billing NDC	17714015060
Package	60 TABLET in 1 BOTTLE (17714-150-60)
Marketing Start Date	2017-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e507a84a-59d5-47f2-a2df-f342e4b093b4 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 631-981-4600, 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 17714-150-60

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:17714-150
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	Marketing End Date
Packaging
1	NDC:17714-150-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2017

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(17714-150)

Revised: 10/2017

Document Id: 5cc973b8-e550-2f6c-e053-2a91aa0a9ab8

Set id: e507a84a-59d5-47f2-a2df-f342e4b093b4

Version: 2

Effective Time: 20171030