Your browser does not support JavaScript! MUCUS ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]
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RxNorm Names

MUCUS ER (guaifenesin) tablet, extended release
[Major Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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: one or two tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Other information

do not use if printed seal under cap is broken or missing
store between 20-25°C (68-77°F)

Inactive ingredients

compressible sugar, copovidone, hydroxyethyl cellulose, silicon dioxide, zinc stearate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Mucus ER™

guaifenesin

extended-release tablets, 600 mg

EXPECTORANT

12 HOUR

Relieves Chest Congestion

Thins and Loosens Mucus

COMPARE TO active ingredient of MUCINEX®

Actual Size

Mucus ER™ Carton Image 1
Mucus ER™ Carton Image 2
MUCUS ER 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-6133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 
SILICON DIOXIDE 
ZINC STEARATE 
Product Characteristics
ColorWHITE ((off-white)) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code L498
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6133-951 in 1 CARTON
120 in 1 BOTTLE
2NDC:0904-6133-391 in 1 CARTON
240 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07891203/20/2013
Labeler - Major Pharmaceuticals (191427277)

Revised: 3/2013
 
Major Pharmaceuticals

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