ENDACON- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid 
Allegis Pharmaceuticals, LLC

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.

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Drug Facts

Active ingredients (in each tablet)

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, USP          20 mg

Guaifenesin, USP                             100 mg

Phenylephrine HCl, USP                   10 mg

Purpose

Dextromethorphan HBr, USP          Cough suppressant

Guaifenesin, USP                               Expectorant

Phenylephrine HCl, USP                   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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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

  • you get nervous, dizzy, or sleepless
  • 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 use.

Keep out of reach of children.

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

Directions

  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children 12 years and over1 to 2 teaspoons every 4 hours
children under12 years of agedo not use

Other information

store at 20°- 25°C (68°- 77°F)

Inactive ingredients

benzoic acid, Bitter Masking agent, citric acid, D&C Red #33, edetate disodium, glycerin, propylene glycol, purified water, sodium citrate dihydrate, sorbitol solution and strawberry flavor.

Questions or Comments?

Call (866) 468-2419

allegis@mct3pl.com

Operation Hours: Monday – Friday 8 AM – 4 PM ET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

edc159c3-figure-01

ENDACON 
dextromethorphan hydrobromide / guaifenesin / phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-701
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
EDETATE DISODIUM 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:28595-701-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/201004/30/2012
Labeler - Allegis Pharmaceuticals, LLC (792272861)
Registrant - Allegis Pharmaceuticals, LLC (792272861)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(28595-701)

Revised: 04/2013
 
Allegis Pharmaceuticals, LLC