Skip to Content

← See all Guaifenesin DM brands

Guaifenesin DM by Pharmaceutical Associates, Inc.

Medically reviewed on February 1, 2018

Dosage form: solution
Ingredients: GUAIFENESIN 200mg in 5mL, DEXTROMETHORPHAN 10mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0809

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.

Maximum Strength
Guaifenesin DM
Non-Narcotic, Sugar and Alcohol Free
Expectorant/Cough Suppressant

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Purposes
Guaifenesin 200 mgExpectorant
Dextromethorphan HBr 10 mgCough Suppressant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use 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
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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
  • shake well before using
  • do not take more than 6 doses in any 24-hour period
    agedose
    adults and children 12 years and over10 mL (2 teaspoonsful) every 4 hours
    children 6 to under 12 years of age5 mL (1 teaspoonful) every 4 hours
    children 2 to under 6 years of age2.5 mL (1/2 teaspoonful) every 4 hours
    children under 2 yearsconsult a doctor

Other information
  • each teaspoonful contains: sodium 4 mg
  • store at 20° - 25°C (68° - 77°F)
  • alcohol/sugar free
  • red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).

Inactive ingredients

Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 118 mL Label

NDC 0121-0809-04

Quality®
Value

Maximum Strength

Guaifenesin DM

Cough & Chest
Congestion

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

ALCOHOL / SUGAR FREE
Relieves Cough /
Maximum Strength
Mucus Relief

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 5 mL Lid

Delivers 5 mL
NDC 0121-4809-05

MAXIMUM STRENGTH
GUAIFENESIN DM

Guaifenesin (Expectorant)
Dextromethorphan HBr (Cough Suppressant)

200 mg/10 mg per 5 mL

Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

GUAIFENESIN DM 
guaifenesin and dextromethorphan solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0809
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN10 mg  in 5 mL
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0809-08237 mL in 1 BOTTLE
2NDC:0121-0809-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/17/2010
GUAIFENESIN DM 
guaifenesin and dextromethorphan solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4809
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN10 mg  in 5 mL
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-4809-054 TRAY (TRAY) in 1 CASE
110 CUP, UNIT-DOSE (CUP) in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
2NDC:0121-4809-104 TRAY (TRAY) in 1 CASE
210 CUP, UNIT-DOSE (CUP) in 1 TRAY
210 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/17/2010
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.044940096MANUFACTURE

 
Pharmaceutical Associates, Inc.

← See all Guaifenesin DM brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide