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NDC 36800-0592-30 Topcare Mucus DM 60; 1200 mg/1; mg/1 Details

Topcare Mucus DM 60; 1200 mg/1; mg/1

Topcare Mucus DM is a ORAL TABLET, EXTENDED RELEASE 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: 36800-0592-30
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: 36800-0592-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	36800-0592
Product ID	36800-592_5a15fc6d-ba27-4a54-9af3-fe98ec1a4a37
Associated GPIs
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	Topcare Mucus DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan HBr, guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	60; 1200
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207602
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0592-30 (36800059230)

Pricing Information	N/A
NDC Package Code	36800-592-30
Billing NDC	36800059230
Package	1 BOTTLE in 1 CARTON (36800-592-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2022-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60108084-4be9-4e8a-b354-9438e1694ebc Details

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes

Cough suppressant

Expectorant

Uses

•: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
•: temporarily relieves:
•: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
•: the intensity of coughing
•: the impulse to cough to help you get to sleep

Warnings

Do not use

•: for children under 12 years of age
•: 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

•: persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
•: cough accompanied by too much phlegm (mucus)

When using this product

•: do not use more than directed

Stop use and ask a doctor if

•: cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 crush, chew, or break tablet
•: take with a full glass of water
•: this product can be administered without regard for timing of meals
•: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
•: children under 12 years of age: do not use

Other information

•: each tablet contains: magnesium 25 mg
•: do not use if printed foil under cap is broken or missing
•: store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO MAXIMUM STRENGTH MUCINEX® DM ACTIVE INGREDIENTS

MAXIMUM STRENGTH

Mucus DM

GUAIFENESIN 1200 mg & DEXTROMETHORPHAN HYDROBROMIDE 60 mg

EXTENDED-RELEASE TABLETS

EXPECTORANT/COUGH SUPPRESSANT

12 HOUR

• Controls Cough

• Thins and Loosens Mucus

28 EXTENDED-RELEASE TABLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE MUCUS DM

dextromethorphan hbr, guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-592
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	YELLOW (light)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	L812
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-592-66	1 in 1 CARTON	09/06/2018
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-592-30	1 in 1 CARTON	07/29/2022
2		28 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207602	09/06/2018

Labeler - Topco Associates LLC (006935977)

Revised: 8/2022

Document Id: 5a15fc6d-ba27-4a54-9af3-fe98ec1a4a37

Set id: 60108084-4be9-4e8a-b354-9438e1694ebc

Version: 2

Effective Time: 20220805