DESPEC- dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquid 
INTERNATIONAL ETHICAL LABS

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 DM-G

Active Ingredient

Active ingredients Purpose

(in each 5 mL teaspoonful)

Dextromethorphan

Hydrobromide 10 mg ................ Antitussive

Guaifenesin 100 mg ................ Expectorant

Phenylephrine

Hydrochloride 5 mg .... Nasal Decongestant

Purpose

Antitussive

Expectorant

Nasal Decongestant

Indications & Usage

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

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.

If pregnant or breast-feeding, ask a health

professional before use.

Ask a doctor

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

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

Keep out of reach of children

In case of overdose, get medical help or

contact a Poison Control Center right away.

Dosage & Administration

Do not exceed recommended dosage.

Use with enclosed dosage cup.

Adults and Children

12 years of age and

over:

Children 6 to under

12 years of age:

Children under 6

years of age:

2 teaspoonfuls (2 TSP)

every 4 hours, not to

exceed 6 doses in

24 hours.

1 teaspoonful (1 TSP)

every 4 hours, not to

exceed 6 doses in

24 hours.

Consult a doctor.

Other safety information

Other information

Store at 59° - 86° F (15° - 30° C)

Inactive ingredient

citric acid, glycerin, grape flavor,

maltitol, propylene glycol, purified water,

sodium citrate, sodium saccharin, and

sorbitol.

Questions? Comments?

Questions? Comments?

Call 1-787-765-3510.

Manufactured for:

International Ethical Laboratories

San Juan PR 00918-2627

Manufactured by:

Woodfield Pharmaceutical, LLC

Houston, TX 77099

Rev. 09/15

Package Label Principal Display Panel

Package label principal display panel

DESPEC 
dextromethorphan hydrobromide, guaifenesin, phenyllephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11584-1047-61 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2016
Labeler - INTERNATIONAL ETHICAL LABS (091176933)
Establishment
NameAddressID/FEIBusiness Operations
WOODFIELD PHARMACEUTICAL, LLC079398730manufacture(11584-1047)

Revised: 10/2018
Document Id: 78727a73-e7aa-bef6-e053-2a91aa0aa4a3
Set id: 65d116e7-8963-0b01-e053-2a91aa0abac0
Version: 3
Effective Time: 20181017
 
INTERNATIONAL ETHICAL LABS