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MucaPlex

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Enzymatic Therapy, LLC
NDC Code: 59800-7232

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.

MucaPlex

Guaifenesin 200 mg

Inactive Ingredients:  carnauba wax, cellulose, dextrin, fenugreek seed extract, glycerin, gum arabic, magnesium stearate, maltodextrin, marshmallow root extract, modified cellulose, modified cellulose gum, mullein leaf extract, povidone, silicon dioxide, stearic acid.

Integrative Therapeutics Brand
Dosage:  Adults and Children 12 years and over:
  1-2 tabs every 4 hours, not to exceed twelve tablets in 24 hours.
Children 6 to 12 years of age: 1/2 to 1 tablets every four hours not to exceed 6 tablets in 24 hours.

Children under 6 years of age:  consult a doctor

Purpose: Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of mucus and make coughs more productive.

Indications:

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

Pregnant or breast feeding warning:

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

Warnings:   Do not use this product if you are pregnant. 

Do not take this product for persistent or chronic cough such as that occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Ask a doctor before use if you:

Are nursing or have diabetes.

Have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Have a cough that is accompanied by excessive phlegm (mucus).

Are taking antibiotics or any presciprtion medication.


Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash or persisient headache.

A persistent cough may be a sign of a serious condition.

Warning for Children:

Keep out of the reach of children.

In case over overdose, get medical help or contact a Poison Control Center immediately.

MucaPlex_H01.jpg

MUCAPLEX 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-7232
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
MICROCRYSTALLINE CELLULOSE 
ICODEXTRIN 
FENUGREEK SEED 
GLYCERIN 
ACACIA 
MAGNESIUM STEARATE 
MALTODEXTRIN 
ALTHAEA OFFICINALIS ROOT 
HYPROMELLOSE, UNSPECIFIED 
CROSCARMELLOSE SODIUM 
MULLEIN LEAF 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
Colorbrown (light brown to gray-brown w/ light and/or dark specks) Scoreno score
ShapeOVAL (Convex face, debossed 232 tablet) Size20mm
FlavorImprint Code232
Contains    
Packaging
#Item CodePackage Description
1NDC:59800-7232-1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2005
Labeler - Enzymatic Therapy, LLC (056544166)
Establishment
NameAddressID/FEIOperations
Schwabe North America, Inc831153908manufacture(59800-7232)

Revised: 08/2016
 
Enzymatic Therapy, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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