FDA Label for Mucus Relief
View Indications, Usage & Precautions
Mucus Relief Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(In Each Extended-Release Tablet)
Guaifenesin 600 mg
Purpose
Expectorant
Use(S)
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warning
.
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
- tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing.
- store between 20 to 25°C (68 to 77°F)
Inactive Ingredients
carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone
Questions?
1-800-616-2471
You may also report side effects to this phone number.
Principal Display Panel
MAJOR®
NDC 0904-6986-40
Compare to the active ingredient in Mucinex® Extended Release 600 mg Tablets*
MUCUS RELIEF
Guaifenesin Extended-Release Tablets, 600 mg
EXPECTORANT
12 HOUR
Relieves Chest Congestion
Thins and Loosens Mucus
500 EXTENDED-RELEASE TABLETS
* Please review the disclaimer below.