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DESPEC

Dosage form: liquid
Ingredients: Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: International Ethical Laboratories, Inc.
NDC Code: 11584-1032

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 LIQUID

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Guaifenesin 100 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Expectorant

Nasal Decongestant

Uses

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

  • 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 reach of children.

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

Directions

Do not exceed recommended dosage

Adults and Children 12 years of age and older:            2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours.
Children under 6 years of age:Consult a doctor. 

Other information

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

Inactive ingredients

Glycerin, Grape Flavor, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, 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:

NDC 11584-1032-6

DESPEC
LIQUID

Expectorant / Nasal Decongestant


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

Sugar Free / Dye Free / Alcohol Free

Grape Flavor

CONTENTS: 1 PINT (473 mL)


Manufactured For:
INTERNATIONAL ETHICAL LABORATORIES, INC.
San Juan, Puerto Rico  00918-2627


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.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Manufactured by:
Pernix Manufacturing, LLC
Houston, TX 77099

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

Iss. 11/13

DESPEC 
guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11584-1032-6473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/02/2002
Labeler - International Ethical Laboratories, Inc. (091176933)
Registrant - International Ethical Laboratories, Inc. (091176933)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC078641814manufacture(11584-1032)

Revised: 12/2013
 
International Ethical Laboratories, Inc.

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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