GUAIFENESIN DM- guaifenesin and dextromethorphan syrup 
Cardinal Health 107, LLC

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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 (1/2 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 per bag, NDC 55154-5785-5

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

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com 

Distributed By:

Cardinal Health

Dublin, OH 43017

L54670891223

R11/16

Principal Display Panel

Guaifenesin Syrup and Dextromethorphan

100 mg/10 mg per 5 mL

5 x 10 mL Cups

Bag Label
GUAIFENESIN DM 
guaifenesin and dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5785(NDC:0121-0638)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-5785-55 in 1 BAG07/01/1992
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 DrugM01207/01/1992
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 1/2024
Document Id: bca2e364-9060-4e80-889c-bae51296ad93
Set id: 9cfb1abb-98c4-4e90-8dd7-fcffc112f988
Version: 5
Effective Time: 20240112
 
Cardinal Health 107, LLC