TOPCARE MUCUS D- guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended release

topcare mucus d by

Drug Labeling and Warnings

topcare mucus d by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Pseudoephedrine HCl 60 mg

Purposes

Expectorant

Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• 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

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days, come back or occur with a 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: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• do not use if printed blister unit is broken or torn
• store between 20-25˚C (68-77˚F)

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO MUCINEX® D ACTIVE INGREDIENTS

Mucus-D

GUAIFENESIN 600 mg

PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg

EXTENDED-RELEASE BI-LAYER TABLETS

EXPECTORANT/NASAL DECONGESTANT

12 HOUR

Clears Nasal/Sinus Congestion

Thins And Loosens Mucus

Immediate and Extended Release

18 EXTENDED-RELEASE BI-LAYER TABLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE MUCUS D 
guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	L6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-801-89	18 in 1 CARTON	08/16/2023
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214407	08/16/2023

Labeler - Topco Associates LLC (006935977)