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Guaifenesin and Dextromethorphan

Dosage form: syrup
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN 10mg in 5mL
Labeler: Cardinal Health
NDC Code: 55154-9446

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 DM

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:

Guaifenesin

100 mg

Dextromethorphan Hydrobromide

10 mg

Inactive Ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

USES
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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.
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 mL (2 teaspoonfuls) every 4 hours

children 6 years to under 12 years

5 mL (1 teaspoonful) every 4 hours

children 2 years to under 6 years

2.5 mL (½ teaspoonful) every 4 hours

children under 2 years

ask a doctor

HOW SUPPLIED

Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

Overbagged with 5 cups (unit dose cups of 5 mL) per bag, NDC 55154-9446-5.

STORAGE

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

R 06/06

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Repackaged By:
Cardinal Health

Zanesville, OH 43701

L51229730116

Principal Display Panel

Guaifenesin Syrup and Dextromethorphan

100 mg/10 mg per 5 mL

5 Unit Dose Cups

GUAIFENESIN AND DEXTROMETHORPHAN 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9446(NDC:0121-0638)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
SACCHARIN SODIUM 
SUCROSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-9446-55 CUP, UNIT-DOSE in 1 BAG
15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/199202/28/2019
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-9446)

 
Cardinal Health

← See all Guaifenesin and Dextromethorphan brands

Medically reviewed on Jun 29, 2018

Further information

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

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