ACTIVE INGREDIENT (in each immediate-release tablet)

Guaifenesin ....................... 400 mg

Purpose

Expectorant

USES

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

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 too much phlegm (mucus)

Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

WARNING

Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

DIRECTIONS

Adults and children 12 years of age and over:
1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
Children 6 to under 12 years:
1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
This product is not recommended for use in children under 6 years of age.
Take with a full glass of water.

OTHER INFORMATION

Tamper-evident: do not use if safety seal band is broken or missing from the bottle.
Store at 25° C (77° F ); excursions permitted to 15° – 30°C (59° – 86° F). See USP Controlled Room Temperature.

INACTIVE INGREDIENTS

Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid.

All prescription substitutions using this product shall be pursuant to state statutes as applicable.
This is not an Orange Book product.

To Report A Serious Adverse Event Contact: (800) 367-3395

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Provident Pharmaceuticals, LLC
Colorado Springs, CO 80919

PL 281
Iss: 04/08

PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle

Breckenridge
Pharmaceutical, Inc.

NDC 51991-606-01

Guaifenesin 400
Tablets

Expectorant

Each immediate-release tablet contains:
Guaifenesin ................... 400 mg

100 TABLETS

DO NOT USE IF SAFETY SEAL BAND IS
BROKEN OR MISSING FROM THE BOTTLE.

GUAIFENESIN 400
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	51991-606
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	400 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium
Hypromellose
Magnesium Stearate
Maltodextrin
Cellulose, Microcrystalline
Povidone
Silicon Dioxide
Stearic Acid

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL (Capsule Shaped)	Size	17mm
Flavor		Imprint Code	B;606
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	51991-606-01	100 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph final	part341	05/01/2008

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Provident Pharmaceuticals, LLC		171901445	MANUFACTURE

Revised: 10/2009Breckenridge Pharmaceutical, Inc.