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GUAIFENESIN by Pharmaceutical Associates, Inc.

Medically reviewed on Jan 29, 2018

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0744

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.

GUAIFENESIN

Expectorant
SUGAR FREE / ALCOHOL FREE

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

USES

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

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.
  • you are hypersensitive to any of the ingredients.

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.

Professional Note

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS

Follow dosage below or use as directed by a physician.

  • do not take more than 6 doses in any 24-hour period.
agedose
adults and children 12 years and over10 to 20 mL
(2 to 4 teaspoonfuls)
every 4 hours
children 6 years to under 12 years5 to 10 mL
(1 to 2 teaspoonfuls)
every 4 hours
children 2 to under 6 years of age2.5 to 5 mL
(½ to 1 teaspoonful)
every 4 hours
children under 2 years of ageconsult a physician

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0121-0744-16

Quality ®
Value

Guaifenesin
Oral Solution USP

100 mg/5 mL

EXPECTORANT

Compare to the
active ingredient in
*Robitussin®

SUGAR FREE/ALCOHOL FREE
LOOSENS AND RELIEVES
CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL

NDC 0121-1744-05

G UAIFENESIN O RAL S OLUTION
USP

100 mg/5 mL

Sugar Free/Alcohol Free

EXPECTORANT

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

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

Delivers 10 mL

NDC 0121-1488-10

G UAIFENESIN O RAL
S OLUTION USP

200 mg/10 mL

Sugar Free/Alcohol Free

EXPECTORANT

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

F17441002

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

Delivers 15 mL

NDC 0121-2232-15

G UAIFENESIN O RAL
S OLUTION USP

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

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

F17441502

GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0744
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0744-04118 mL in 1 BOTTLE
2NDC:0121-0744-08237 mL in 1 BOTTLE
3NDC:0121-0744-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2002
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1744
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1744-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1744-055 mL in 1 CUP, UNIT-DOSE
2NDC:0121-1744-1010 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
210 mL in 1 CUP, UNIT-DOSE
3NDC:0121-1744-1510 TRAY in 1 CASE
310 CUP, UNIT-DOSE in 1 TRAY
315 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2002
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1488
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
ACESULFAME POTASSIUM 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1488-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1488-1010 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2002
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-2232
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN300 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
ACESULFAME POTASSIUM 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-2232-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-2232-1515 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2002
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693manufacture(0121-0744, 0121-1744, 0121-1488, 0121-2232)

 
Pharmaceutical Associates, Inc.

← See all GUAIFENESIN brands

Further information

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

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