Label: MUCUS ER- guaifenesin tablet, extended release
- NDC Code(s): 0904-6133-39, 0904-6133-95
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 25, 2013
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- Active ingredient (in each extended-release tablet)
Guaifenesin 600 mgClose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productiveClose
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.
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)
- 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 stearateClose
- Questions or comments?
- Package/Label Principal Display Panel
extended-release tablets, 600 mg
Relieves Chest Congestion
Thins and Loosens Mucus
COMPARE TO active ingredient of MUCINEX®
- INGREDIENTS AND APPEARANCE
guaifenesin tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6133 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg Inactive Ingredients Ingredient Name Strength COPOVIDONE K25-31 (UNII: D9C330MD8B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ZINC STEARATE (UNII: H92E6QA4FV) Product Characteristics Color WHITE ((off-white)) Score no score Shape ROUND Size 12mm Flavor Imprint Code L498 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6133-95 1 in 1 CARTON 1 20 in 1 BOTTLE 2 NDC:0904-6133-39 1 in 1 CARTON 2 40 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078912 03/20/2013 Labeler - Major Pharmaceuticals (191427277)