DESPEC

International Ethical Laboratories, Inc.
Pernix Manufacturing, LLC

DESPEC DM SYRUP

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• DESPEC Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of the reach of children.
• Directions
• DESPEC Other information
• Inactive ingredients
• Questions? Comments?
• PRODUCT PACKAGING:

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients                         
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 10 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg

Purpose

Antitussive
Expectorant
Nasal Decongestant

DESPEC 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.

DESPEC Other information

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

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 11584-1046-4

DESPEC DM SYRUP

NEW FORMULATION

Antitussive, Expectorant & Nasal Decongestant

Cold & Cough

Childrens and Adults

Sugar Free · Dye Free · Alcohol Free · Grape Flavor

Each teaspoonful (5 mL) contains:
Dextromethorphan HBr.........10 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:  Pernix Manufacturing, LLC, Houston TX  77099. Rev. 11/13