MUCUS RELIEF- guaifenesin tablet

MUCUS RELIEF by

Drug Labeling and Warnings

MUCUS RELIEF by is a Otc medication manufactured, distributed, or labeled by Clinical Solutions Wholesale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:  Each immediate-release tablet contains – Guaifenesin 400 mg

PURPOSE

PURPOSE:  Expectorant

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 right away

INDICATIONS & USAGE

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.

WARNINGS

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 excessive phlegm (mucus)

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist.  Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

INACTIVE INGREDIENT

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Principal Display Panel

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58118-9896(NDC:49483-272)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONES (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58118-9896-3	30 in 1 BOTTLE, PLASTIC
2	NDC: 58118-9896-6	60 in 1 BOTTLE, PLASTIC
3	NDC: 58118-9896-9	90 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/23/2012

Labeler - Clinical Solutions Wholesale (078710347)

Registrant - Clinical Solutions Wholesale (078710347)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Solutions Wholesale		078710347	REPACK(58118-9896) , RELABEL(58118-9896)