TOPCARE MUCUS ER- guaifenesin tablet, multilayer, extended release 
Topco Associates LLC

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Topco Associates LLC. Mucus ER Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

for children under 12 years of age

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)

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 the timing of meals
adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B, FD&C blue #1 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® ACTIVE INGREDIENT

Mucus ER

GUAIFENESIN

EXTENDED-RELEASE TABLETS, 600 mg

EXPECTORANT

12 HOUR

• Relieves Chest Congestion

• Thins and Loosens Mucus

• Immediate and Extended Release

40 EXTENDED-RELEASE TABLETS

actual size

Mucus ER image
TOPCARE MUCUS ER 
guaifenesin tablet, multilayer, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code L2X2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-123-581 in 1 CARTON09/29/2022
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:76162-123-601 in 1 CARTON11/04/2024
220 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891209/29/2022
Labeler - Topco Associates LLC (006935977)

Revised: 12/2024
Document Id: e0a05c1e-af6d-4d2d-9d0e-80f1821f5266
Set id: e3c900ad-21b1-4cd0-8c48-f54f115df403
Version: 3
Effective Time: 20241212
 
Topco Associates LLC