DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

Dextromethorphan HBr. and Guaifenesin by

Drug Labeling and Warnings

Dextromethorphan HBr. and Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Everpharm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

DOSAGE & ADMINISTRATION

Directions

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

20 mg-200 mg/10 mL

age	dose
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

• age: dose
• Children under 6 years of age: Do not use
• Children 6 to under 12 years of age: 5 mL (1 unit dose) every 4 hours
• Adults and children over 12 years of age: 10 mL (2 unit dose) every 4 hours

OTHER SAFETY INFORMATION

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 INGREDIENT

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

QUESTIONS

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

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

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84415-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84415-014-01	100 in 1 BOX, UNIT-DOSE	01/16/2025
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/16/2025

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84415-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84415-011-01	100 in 1 BOX, UNIT-DOSE	06/12/2023
1		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012.85	06/12/2023

Labeler - Everpharm LLC (119288836)