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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 DEA Schedule 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)