DEXTROMETHORPHAN HBR. AND GUAIFENESIN- dextromethorphan hbr. and guaifenesin solution 
Everpharm LLC

----------

DRUG FACTS

10 mg-100 mg/5 mL -

Active ingredient per 5 mL(1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL(1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

Purpose

Cough Suppressant

Expectorant

Uses

•   temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•   helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not useif 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 ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

If pregnant or breast-feeding,ask a healthcare professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•   do not take more than 6 doses in any 24 hour period

20 mg-200 mg/10 mL

agedose
Children under 12 years of age

Do not use

Adults and children over 12 years of age

10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

agedose
Children under 6 years of ageDo not use
Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours

Other Information
•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

Inactive Ingredientscitric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

Questions or comments? Call (866) 838-3774

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-014-01

Dextromethorphan HBr. 

and Guaifenesin 

Oral Solution

Cough Suppressant/

Expectorant

10 mg-100 mg/5 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 5 mL Unit-Dose Cups

10label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EverPharm

NDC 84415-011-01

Dextromethorphan HBr.

and Guaifenesin

Oral Solution

Cough Suppressant/

Expectorant

20 mg-200 mg/10 mL

• Alcohol Free

• Sugar Free

• Cherry Flavor

For Institutional Use Only

100 x 10 mL Unit-Dose Cups

5label

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84415-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84415-014-01100 in 1 BOX, UNIT-DOSE01/16/2025
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 DrugM01201/16/2025
DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84415-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84415-011-01100 in 1 BOX, UNIT-DOSE06/12/2023
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 DrugM012.8506/12/2023
Labeler - Everpharm LLC (119288836)

Revised: 1/2025
Document Id: 2bda25ff-9e45-8f8d-e063-6294a90a6a0f
Set id: 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb
Version: 1
Effective Time: 20250116
 
Everpharm LLC