MUCOSA- guaifenesin tablet

MUCOSA by

Drug Labeling and Warnings

MUCOSA by is a Otc medication manufactured, distributed, or labeled by Apace Packaging, LLC, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

NDC 50268-383-15
Immediate-release GUAIFENESIN
400 mg
50 Tablets (5 x 10) Unit Dose

5026838315

NDC 50268-383-15
Immediate-release GUAIFENESIN
400 mg
50 Tablets (5 x 10) Unit Dose

5026838315

EXPECTORANT
●Relieves Chest Congestion
●Thins and Loosens Mucus

PURPOSE

DRUG FACTS:

ACTIVE INGREDIENT 
(Each immediate-release tablet) contains 
Guaifenesin 400 mg........Expectorant

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

KEEP OUT OF REACH OF CHILDREN

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)

When using this product

do not exceed recommended dosage
do not use for more than 7 days

INDICATIONS & USAGE

Stop use and ask a doctor if

cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

WARNINGS

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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

OTHER INFORMATION

store at 25ºC (77º) excursions permitted between 15º - 30ºC (59º - 86ºF)
keep in a dry place and do not expose to excessive heat

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENTS

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

Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Mfg. Rev. 272R 0909         AV 03/15 (P)

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCOSA 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15338-770(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)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15338-770-05	50 in 1 BOX, UNIT-DOSE	03/11/2015
1	NDC: 15338-770-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/11/2015

Labeler - Apace Packaging, LLC (361961142)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(15338-770)

Establishment
Name	Address	ID/FEI	Business Operations
Apace Packaging, LLC		361961142	repack(15338-770) , label(15338-770)