DailyMed - DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

NDC Code(s): 84415-011-01, 84415-014-01
Packager: Everpharm LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated January 16, 2025

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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 ...

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
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Purpose
Cough Suppressant - Expectorant

Cough Suppressant

Expectorant
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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 ...

• 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
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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 ...

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)

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DOSAGE & ADMINISTRATION

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 ...

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

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

Inactive Ingredientscitric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
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QUESTIONS
Questions or comments? Call (866) 838-3774

Questions or comments? Call (866) 838-3774

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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 ...

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

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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 ...

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

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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

INGREDIENTS AND APPEARANCE

Product Information

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012.85	06/12/2023

Labeler - Everpharm LLC (119288836)

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	RxCUI	RxNorm NAME	RxTTY
1	996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN
2	996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD
3	996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY
4	996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY
5	996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY

Label: DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

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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

	NDC
1	84415-011-01
2	84415-014-01

Label: DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

View Package Photos

Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Ask a doctor before use if you have

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Safety

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More Info on this Drug

DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

Number of versions: 1

DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

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DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.