Search by Drug Name or NDC

NDC 63654-0345-20 Mucus Relief 20; 400 mg/1; mg/1 Details

Mucus Relief 20; 400 mg/1; mg/1

Mucus Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Selder, S.A. de C.V.. 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: 63654-0345-20
Last Updated: 12/01/2022
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: 63654-0345-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63654-0345
Product ID	63654-345_b56ab82f-ccee-49b0-9cc4-eadd8927a0d8
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifensin, Dextromethorphan
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	Selder, S.A. de C.V.
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	2023-12-31

Package

Package Images

NDC 63654-0345-20 (63654034520)

Pricing Information	N/A
NDC Package Code	63654-345-20
Billing NDC	63654034520
Package	2 BLISTER PACK in 1 CARTON (63654-345-20) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2014-12-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1e90c836-72ed-4965-9ccd-d5f65eb45b0e Details

Active ingredients

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

Expectorant

Cough suppressant

Uses

■ helps loosen phlegm (mucus)

■ helps thin bronchial secretions to make coughs more productive

■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

■ cough accompanied by excessive phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

■ do not exceed recommended dosage

■ do not use for more than 7 days.

Stop use and ask a doctor if

■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use.

Other information

■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)

■ Keep in a dry place and do not expose to heat

■ do not use if blister package is torn or open.

Inactive ingredients

croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions or Comments?

Call toll free 1-888-952-0050 Monday through Friday 9 AM - 5 PM EST.

Principal Display Panel

XL-3 Mucus Relief

INGREDIENTS AND APPEARANCE

MUCUS RELIEF

guaifensin, dextromethorphan tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63654-345
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	14mm
Flavor		Imprint Code	AZ;345
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63654-345-20	2 in 1 CARTON	12/23/2014
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/23/2014

Labeler - Selder, S.A. de C.V. (824413629)

Revised: 12/2016

Document Id: b56ab82f-ccee-49b0-9cc4-eadd8927a0d8

Set id: 1e90c836-72ed-4965-9ccd-d5f65eb45b0e

Version: 5

Effective Time: 20161222