DrugCite

GUAIFENESIN DM - guaifenesin and dextromethorphan solution 
Pharmaceutical Associates, Inc.

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 mg Expectorant
Dextromethorphan HBr 10 mg Cough 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
    age dose
    adults and children 12 years and over 10 mL (2 teaspoonsful) every 4 hours
    children 6 to under 12 years of age 5 mL (1 teaspoonful) every 4 hours
    children 2 to under 6 years of age 2.5 mL (1/2 teaspoonful) every 4 hours
    children under 2 years consult 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 - 118 mL Label

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

PRINCIPAL DISPLAY PANEL - 5 mL Lid

GUAIFENESIN DM 
guaifenesin and dextromethorphan  solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0121-0809
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0121-0809-08 237 mL In 1 BOTTLE None
2 0121-0809-04 118 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/17/2010

GUAIFENESIN DM 
guaifenesin and dextromethorphan  solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0121-4809
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0121-4809-05 4 TRAY In 1 CASE contains a TRAY
1 10 CUP In 1 TRAY This package is contained within the CASE (0121-4809-05) and contains a CUP, UNIT-DOSE
1 5 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-4809-05)
2 0121-4809-10 4 TRAY In 1 CASE contains a TRAY
2 10 CUP In 1 TRAY This package is contained within the CASE (0121-4809-10) and contains a CUP, UNIT-DOSE
2 10 mL In 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-4809-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/17/2010

Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc. 044940096 MANUFACTURE
Revised: 02/2010Pharmaceutical Associates, Inc.