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NDC 63187-0040-04 Q Tussin DM 10; 100 mg/5mL; mg/5mL Details

Q Tussin DM 10; 100 mg/5mL; mg/5mL

Q Tussin DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 63187-0040-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 63187-0040-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	63187-0040
Product ID	63187-040_550c050b-4295-488a-a482-7105dacbca5d
Associated GPIs	43997002521220
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Q Tussin DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr and Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	10; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0040-04 (63187004004)

Pricing Information	N/A
NDC Package Code	63187-040-04
Billing NDC	63187004004
Package	118 mL in 1 BOTTLE, PLASTIC (63187-040-04)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a3eff326-b2c6-4e2a-a424-912511433467 Details

Active ingredients (in each 5 mL = 1 tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 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 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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

Directions

•: do not take more than 6 doses in any 24-hour period
•: this adult product is not intended for use in children under 12 years of age

age (yr)	dose (tsp)
adults and children 12 years and over	2 teaspoons every 4 hours
children under 12 years	do not use

Other information

•: store at 15° to 30°C (59° to 86°F)
•: dosage cup provided

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

SPL UNCLASSIFIED SECTION

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 7/09 R4

8281171 0855

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Q TUSSIN DM

dextromethorphan hbr and guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-040(NDC:0603-0855)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	RED (clear, red)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-040-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/01/1995

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-040) , RELABEL(63187-040)

Revised: 11/2019

Document Id: 550c050b-4295-488a-a482-7105dacbca5d

Set id: a3eff326-b2c6-4e2a-a424-912511433467

Version: 3

Effective Time: 20191101

Search by Drug Name or NDC

NDC 63187-0040-04 Q Tussin DM 10; 100 mg/5mL; mg/5mL Details

Q Tussin DM 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63187-0040-04 (63187004004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a3eff326-b2c6-4e2a-a424-912511433467 Details

Active ingredients (in each 5 mL = 1 tsp)

Purpose

Uses

Warnings

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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