Endacon liquid

Spl unclassified section

Drug Facts

Active ingredients (in each tablet)

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr, USP20 mg

Guaifenesin, USP100 mg

Phenylephrine HCl, USP10 mg

Purpose

Dextromethorphan HBr, USPCough suppressant

Guaifenesin, USPExpectorant

Phenylephrine HCl, USPNasal 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
age dose
adults and children 12 years and over 1 to 2 teaspoons every 4 hours
children under12 years of age do not use

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

Ingredients and appearance - Product information

Endacon liquid- Dextromethorphan hydrobromide / guaifenesin / phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 28595-701
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Benzoic acid ( UNII: 8SKN0B0MIM)
Citric acid monohydrate ( UNII: 2968PHW8QP)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Edetate disodium ( UNII: 7FLD91C86K)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium citrate ( UNII: 1Q73Q2JULR)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color RED Flavor STRAWBERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Allegis Pharmaceuticals, LLC( 792272861)

Establishment

Name ID/FEI Business Operations
Allegis Pharmaceuticals, LLC 792272861 MANUFACTURE( 28595-701)

Package label.principal display panel