BRONCHORIL- guaifenesin tablet
Enzymatic Therapy, LLC

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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Bronchoril

Guaifenesin 200 mg

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

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.

Inactive Ingredients: Mullein Leaf Powder, Fenugreek Extract, PAPA (USP), Marshamallow Extract, Microcrystalline Cellulose, Magnesium Stearate, Stearic Acid, Croscarmellose Sodium.

Pregnant or breast feeding warning:

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

Warnings: Ask a doctor before use if you have:
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or a cough that is accompanied by excessive phlegm (mucus).

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

Bronchoril
Guaifenesin 200 mg

Bronchoril.jpg

BRONCHORIL
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:59800-1232
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	200 mg

Ingredient Name	Strength
Inactive Ingredients
FENUGREEK LEAF
AMINOBENZOIC ACID
ALTHAEA OFFICINALIS ROOT
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MULLEIN LEAF

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59800-1232-1	100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/19/2003	03/31/2013

Labeler - Enzymatic Therapy, LLC (056544166)

Name	Address	ID/FEI	Business Operations
Establishment
Enzymatic Therapy, LLC		056544166	manufacture(59800-1232)

Revised: 5/2014

Document Id: 39e02bc8-1c04-4ecd-8a9e-432c8d4a938b

Set id: bb325669-51d9-4c90-9691-96f10606a640

Version: 2

Effective Time: 20140505

Enzymatic Therapy, LLC