MUCUS RELIEF- guaifenesin tablet
Clinical Solutions Wholesale

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Mucus Relief 400mg

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

PURPOSE: Expectorant

KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or contact a Poison Control Center right away

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

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)

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.

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

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Principal Display Panel

MUCUS RELIEF
guaifenesin tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/23/2012

Labeler - Clinical Solutions Wholesale (078710347)

Registrant - Clinical Solutions Wholesale (078710347)

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