DESPEC - guaifenesin and phenylephrine hydrochloride liquid
International Ethical Laboratories, Inc.

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.

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DESPEC LIQUID

Drug Facts

Active ingredients Purpose
(in each 5 mL teaspoonful)
Guaifenesin 100 mg........................... Expectorant
Phenylephrine Hydrochloride 5 mg.... 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
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
a cough that occurs with too much phlegm (mucus)

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. These could be signs 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 accidental overdose seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage

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

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.

Distributed for:
International Ethical Laboratories, Inc.
San Juan, Puerto Rico

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 11584-1032-6

DESPEC
LIQUID

Expectorant / 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

Side Panel:

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 not to be dispensed to consumer.

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Distributed for:
International Ethical Laboratories, Inc.
San Juan, Puerto Rico

Iss. 05/09

DESPEC
guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11584-1032
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL
Phenylephrine Hydrochloride (Phenylephrine)	Phenylephrine Hydrochloride	5 mg in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11584-1032-6	473 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/02/2002

Labeler - International Ethical Laboratories, Inc. (091176933)

Registrant - International Ethical Laboratories, Inc. (091176933)

Name	Address	ID/FEI	Business Operations
Establishment
Great Southern Laboratories		056139553	manufacture

Revised: 11/2009

Document Id: 56c65674-3df5-404a-bc71-a9f11332a4ae

Set id: 5e7c3fe6-ea77-4472-8a4c-4a015ad01fd5

Version: 1

Effective Time: 20091116

International Ethical Laboratories, Inc.