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Guaifenesin

Dosage form: liquid
Ingredients: GUAIFENESIN 200mg in 10mL
Labeler: Cardinal Health
NDC Code: 55154-9425

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 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.

Principal Display Panel

Guaifenesin Oral Solution USP

200 mg/10 mL

5 Cups

GUAIFENESIN 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9425(NDC:0121-1744)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CITRIC ACID MONOHYDRATE 
FD&C GREEN NO. 3 
FD&C RED NO. 40 
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-9425-55 CUP in 1 BAG
110 mL in 1 CUP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-9425)

Revised: 03/2015
 
Cardinal Health

Further information

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

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