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 Advanced Rx Llc. 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.
Other
Drug Facts
Distributed by:
ADVANCED RX LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A
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
Warnings
Otc - Do Not Use
Do not use
■ for children under 12 years of age
Otc - Ask Doctor
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)
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 between 20° to 25°C (68° to 77°F)
■ DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients
carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Questions?
Call toll-free 1-800-630-8895
Principal Display Panel
NDC 80513-403-20
*Compare to the active ingredient in Mucinex ®
Mucus Relief
Guaifenesin 600 mg
Expectorant
EXTENDED-RELEASE TABLETS BI-LAYER TABLETS
200 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ®Extended-Release 600 mg Tablets
* Please review the disclaimer below.
