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Mucus Relief by Selder, S.A. de C.V.

Medically reviewed on December 22, 2016

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-345

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

XL-3 Mucus Relief

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.

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XL-3 Mucus Relief

 

MUCUS RELIEF 
guaifensin, dextromethorphan tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-345
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize14mm
FlavorImprint CodeAZ;345
Contains    
Packaging
#Item CodePackage Description
1NDC:63654-345-202 BLISTER PACK in 1 CARTON
110 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/23/2014
Labeler - Selder, S.A. de C.V. (824413629)

 
Selder, S.A. de C.V.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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