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DESPEC DM by International Ethical Laboratories, Inc.

Dosage form: syrup
Ingredients: Dextromethorphan Hydrobromide 15mg in 5mL, Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: International Ethical Laboratories, Inc.
NDC Code: 11584-1045

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.

DESPEC DM SYRUP

Drug Facts

Active ingredients                         
(in each 5 mL teaspoonful)

Dextromethorphan Hydrobromide 15 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg

Purpose

Antitussive
Expectorant
Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product
  • 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
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions Do not exceed recommended dosage.
  • Use with enclosed dosage cup.
Adults and
Children 12
years of age
and over:


2 teaspoonfuls (2 TSP)
every 6 hours, not to
exceed 4 doses in 24
hours.


Children 6 to
under 12 years
of age:



1 teaspoonful (1 TSP)
every 6 hours, not to
exceed 4 doses in 24
hours.


Children under
6 years of age:
Consult a doctor.


Other information

Store at 59o - 86oF (15o - 30oC)

Inactive ingredients

citric acid, glycerin, grape flavor, maltitol, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Questions? Comments?

Call 1-787-765-3510.

Manufactured for:
International Ethical Laboratories, Inc.
San Juan, Puerto Rico 00918-2627

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 120 mL Label:

NDC 11584-1045-4

DESPEC DM SYRUP

Antitussive, Expectorant & Nasal Decongestant

Cold & Cough

Childrens and Adults

Sugar Free · Dye Free · Alcohol Free · Grape Flavor

Each teaspoonful (5 mL) contains:
Dextromethorphan HBr........... 15 mg
Guaifenesin..........................100 mg
Phenylephrine HCl.................. 5 mg

4 FL OZ (120 mL)

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

Manufactured for:  International Ethical Laboratories, San Juan PR  00918-2627

Manufactured by:  Great Southern Laboratories, Houston TX  77099. Rev. 05/12


















DESPEC  DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1045
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Maltitol 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium Dihydrate 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11584-1045-512 BOTTLE (BOTTLE) in 1 TRAY
115 mL in 1 BOTTLE
2NDC:11584-1045-4120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/200208/30/2015
Labeler - International Ethical Laboratories, Inc. (091176933)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(11584-1045)

Revised: 04/2014
 
International Ethical Laboratories, Inc.

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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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