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NDC 36800-0359-26 Topcare Tussin DM 20; 200 mg/10mL; mg/10mL Details

Topcare Tussin DM 20; 200 mg/10mL; mg/10mL

Topcare Tussin DM is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0359-26
Last Updated: 11/30/2022
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: 36800-0359-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	36800-0359
Product ID	36800-359_c91450dd-5fd1-4919-bbc8-0dca11726508
Associated GPIs	43997002520910
GCN Sequence Number	000652
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53491
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Topcare Tussin DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Hydrobromide, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	20; 200
Active Ingredient Units	mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Topco Associates LLC
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 36800-0359-26 (36800035926)

Pricing Information	N/A
NDC Package Code	36800-359-26
Billing NDC	36800035926
Package	1 BOTTLE in 1 CARTON (36800-359-26) / 118 mL in 1 BOTTLE
Marketing Start Date	1991-08-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e863d70e-8b6a-423b-98d7-886b49edb05d Details

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

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

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 (1-800-222-1222).

Directions

•: do not take more than 6 doses in any 24-hour period
•: measure only with dosing cup provided
•: keep dosing cup with product
•: mL = milliliter
•: this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	do not use

Other information

•: each 10 mL contains: sodium 6 mg
•: store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO ROBITUSSIN® COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS

NON-DROWSY

Tussin DM

Cough & Chest Congestion

COUGH SUPPRESSANT-DEXTROMETHORPHAN HBr

EXPECTORANT-GUAIFENESIN

OUR PHARMACISTS RECOMMEND

RELIEVES:

Cough

Mucus

Adult For Ages 12 & Over

8 FL OZ (237 mL)

CHERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE TUSSIN DM

dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-359
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. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (Orange-Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-359-26	1 in 1 CARTON	08/14/1991
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-359-34	1 in 1 CARTON	07/16/1992
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:36800-359-40	1 in 1 CARTON	08/21/2000	02/28/2022
3		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/14/1991

Labeler - Topco Associates LLC (006935977)

Revised: 11/2021

Document Id: c91450dd-5fd1-4919-bbc8-0dca11726508

Set id: e863d70e-8b6a-423b-98d7-886b49edb05d

Version: 6

Effective Time: 20211115