DESPEC DM- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup 
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 DM

Drug Facts

Active ingredients ( in each 5 mL teaspoonful)

Dextromethorphan Hydrobromide 10mg

Guaifenesin 100mg

Phenylephrine Hydrochloride 5mg

Purpose

Antitussive/ Expectroant/ Nasal Decongestant

Uses

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

Warnings

Do not exceed recommended dosage

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

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 recommeneded dosage.

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

Other information

Store at room temperature 59°-86°F (15°-30°C)

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

Principal Display Panel-Label

BookletBase labelPrincipal Display Panel-120 mL Bottle Label

DESPEC  DM
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11584-1046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
MALTITOL (UNII: D65DG142WK)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11584-1046-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/19/2014
Labeler - International Ethical Laboratories, Inc (091176933)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(11584-1046)

Revised: 11/2021
Document Id: cfd4ca03-bbc0-3f6c-e053-2995a90aa2d9
Set id: cbc473b9-0871-4b91-abc5-919f6a4019c3
Version: 5
Effective Time: 20211102
 
International Ethical Laboratories, Inc