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Xpecto soothing relief by BRONCOLIN, S.A. de C.V.

Dosage form: syrup
Ingredients: GUAIFENESIN 200mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 10mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 10mL
Labeler: BRONCOLIN, S.A. de C.V.
NDC Code: 62583-003

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.

Drug Facts

Active ingredient (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purposes

Cough suppressant

Expectorant

Nasal Decongestant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold
  • nasal congestion
  • cough due to minor throat and bronchial irritation

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
  • trouble urinating due to enlarged prostate gland
  • high blood pressure
  • thyroid disease • heart disease • diabetes
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant

When using this product

do not use more than directed

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

If pregnant or breast-feeding

ask a health professional before

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • shake well before using
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product mL=milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10mL every 4 hours
  • children under 12 years: do not use

Other information
  • store at 20C-25C (68F-77F). Do not refrigerate

Inactive ingredients

anhydrous citric acid,FD&C Red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

Call 703-802-9363

Package Label

XPECTO  SOOTHING RELIEF
dextromethorphan hbr guaifenesin phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62583-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
SORBITOL 
GLYCERIN 
LACTIC ACID 
MENTHOL 
PROPANEDIOL 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
Product Characteristics
Colorred (Cherry Red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62583-003-14118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/09/2016
Labeler - BRONCOLIN, S.A. de C.V. (812946390)

 
BRONCOLIN, S.A. de C.V.

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Medically reviewed on May 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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