MUCAPLEX- guaifenesin tablet

MucaPlex by

Drug Labeling and Warnings

MucaPlex by is a Otc medication manufactured, distributed, or labeled by Schwabe North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Guaifenesin 200 mg

INACTIVE INGREDIENT

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.

DOSAGE & ADMINISTRATION

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.

PREGNANCY OR BREAST FEEDING

Pregnant or breast feeding warning:

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

WARNINGS

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 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.

KEEP OUT OF REACH OF CHILDREN

Warning for Children:

Keep out of the reach of children.

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

PRINCIPAL DISPLAY PANEL

MucaPlex_H01.jpg

INGREDIENTS AND APPEARANCE

MUCAPLEX 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59800-7232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ICODEXTRIN (UNII: 2NX48Z0A9G)
FENUGREEK SEED (UNII: 654825W09Z)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MULLEIN LEAF (UNII: 9936O846LI)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	brown (light brown to gray-brown w/ light and/or dark specks)	Score	no score
Shape	OVAL (Convex face, debossed 232 tablet)	Size	20mm
Flavor		Imprint Code	232
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59800-7232-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2005

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(59800-7232)