Mucus Relief

Manufacturer: Selder, S.A. de C.V.
Effective date: 2016-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 23:03:42

Label at a glance#

ProductMucus Relief

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Indications and 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.

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact1-888-952-0050

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Dextromethorphan HBr 20 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

■ do not exceed recommended dosage

■ do not use for more than 7 days.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

■ 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

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XL-3 Mucus Relief

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1147685	Dextromethorphan/guaiFENesin (Oral Pill)	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD Active

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63654-345-20	2020-12-07	C162847	48780-1	9d75b9d0-9ca0-f424-e053-dadaa90a57ce	345 - XL-3 Mucus Relief
63654-345-20	2020-01-31	C162847	48780-1	9d75b9d0-9ca0-f424-e053-dadaa90a57ce	345 - XL-3 Mucus Relief

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Mucus Relief
Guaifensin, Dextromethorphan
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
CROSCARMELLOSE SODIUM
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POVIDONE
SILICON DIOXIDE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63654-345	63654-345-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e14f0d7b-cdb0-4440-9b1f-337af1b8e0aa			1e90c836-72ed-4965-9ccd-d5f65eb45b0e	2016-12-22	Warnings	Exact identifier spl set id: 1e90c836-72ed-4965-9ccd-d5f65eb45b0e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.