GUAIFENESIN- guaifenesin solution 
Cardinal Health 107, LLC

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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 over

10 to 20 mL
(2 to 4 teaspoonfuls)
every 4 hours

children 6 years to under 12 years

5 to 10 mL
(1 to 2 teaspoonfuls)
every 4 hours

children 2 to under 6 years of age

2.5 to 5 mL
(½ to 1 teaspoonful)
every 4 hours

children under 2 years of age

consult a physician

STORAGE

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

Distributed by

Cardinal Health

Dublin, OH 43017

L53963870124

L54670551223

Principal Display Panel

Guaifenesin Oral Solution, USP

200 mg/10 mL

5 cups

Bag Label

Principal Display Panel

Guaifenesin Oral Solution USP

100 mg/5 mL

5 Cups

Bag Label
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5780(NDC:0121-1488)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-5780-55 in 1 BAG09/01/2002
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/01/2002
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9450(NDC:0121-1744)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-9450-55 in 1 BAG09/01/2002
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/01/2002
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2024
Document Id: 0910827a-8299-4d01-9c4f-6b97843431ed
Set id: 888b6a2e-6631-4585-a7fe-eb122eb51b23
Version: 8
Effective Time: 20240109
 
Cardinal Health 107, LLC