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NDC 36800-0300-26 Topcare Tussin 30 mg/10mL Details

Topcare Tussin 30 mg/10mL

Topcare Tussin 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.

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: 36800-0300-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	36800-0300
Product ID	36800-300_c5589361-9f74-4b6e-8521-22255a5cfd94
Associated GPIs	43102030501215
GCN Sequence Number	016524
GCN Sequence Number Description	dextromethorphan HBr LIQUID 15 MG/5 ML ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17748
HICL Sequence Number	001925
HICL Sequence Number Description	DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Topcare Tussin
Proprietary Name Suffix	Cough Long Acting
Non-Proprietary Name	Dextromethorphan Hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
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 36800-0300-26 (36800030026)

Pricing Information	N/A
NDC Package Code	36800-300-26
Billing NDC	36800030026
Package	1 BOTTLE in 1 CARTON (36800-300-26) / 118 mL in 1 BOTTLE
Marketing Start Date	1992-10-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bb634574-30fe-4f85-9aa1-67edb7871443 Details

Active ingredient (in each 10 mL)

Dextromethorphan HBr, USP 30 mg

Purpose

Cough suppressant

Uses

•: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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 or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with 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 4 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 6 to 8 hours
children under 12 years	do not use

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO ROBITUSSIN® LONG-ACTING COUGH ACTIVE INCREDIENT

NON-DROWSY

Tussin

Cough

Long-Acting

COUGH SUPPRESSANT-

DEXTROMETHORPHAN HBr

OUR PHARMACISTS RECOMMEND

UP TO 8 HOURS

RELIEVES:

Cough For Up to 8 Hours

ALCOHOL 1.4%

Adult

For Ages 12 & Over

4 FL OZ (118 mL)

ORIGINAL FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE TUSSIN COUGH LONG ACTING

dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-300
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-300-26	1 in 1 CARTON	10/21/1992
1		118 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	10/21/1992

Labeler - Topco Associates LLC (006935977)

Revised: 3/2018

Document Id: c5589361-9f74-4b6e-8521-22255a5cfd94

Set id: bb634574-30fe-4f85-9aa1-67edb7871443

Version: 3

Effective Time: 20180329