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DESPEC

International Ethical Laboratories, Inc.
Pernix Manufacturing, LLC

DESPEC DM SYRUP


FULL PRESCRIBING INFORMATION: CONTENTS*




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.
Adults and
Children 12
years of age
and over:

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

Children 6 to
under 12 years
of age:


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

Children under
6 years of age:
Consult a doctor.

DESPEC 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 11584-1046-4

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

DESPEC

DESPEC

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DESPEC

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11584-1046
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
MALTITOL
propylene glycol
water
SODIUM CITRATE
SACCHARIN SODIUM DIHYDRATE
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 NDC:11584-1046-4 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-02


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Be sure to consult your doctor before taking any medication!
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