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MUCOSA

Medically reviewed by Drugs.com. Last updated on Nov 10, 2021.

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: Apace Packaging, LLC
NDC Code: 15338-770

Guaifenesin (Product contract packaged by Apace Packaging, LLC)


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


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.


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

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.

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

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)

MUCOSA 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15338-770(NDC:49483-272)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize12mm
FlavorImprint CodeTCL272
Contains    
Packaging
#Item CodePackage Description
1NDC:15338-770-0550 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:15338-770-111 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/11/2015
Labeler - Apace Packaging, LLC (361961142)
Establishment
NameAddressID/FEIOperations
Time Cap Laboratories, Inc.037052099manufacture(15338-770)
Establishment
NameAddressID/FEIOperations
Apace Packaging, LLC361961142repack(15338-770), label(15338-770)

 
Apace Packaging, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.