345 - 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.

Principal Display Panel

XL-3 Mucus Relief

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	Marketing End Date
Packaging
1	NDC:63654-345-20	2 in 1 CARTON	12/23/2014	12/31/2018
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 Drug	M012	12/23/2014	12/31/2018

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

Revised: 12/2016

Document Id: e14f0d7b-cdb0-4440-9b1f-337af1b8e0aa

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

Version: 6

Effective Time: 20161222

Selder, S.A. de C.V.