GUAIFENESIN 400 - guaifenesin tablet 
Breckenridge Pharmaceutical, Inc.

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Guaifenesin 400
Tablets

Drug Facts

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

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

OTHER INFORMATION

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.

Principal Display Panel - 100 Tablets 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  
Hypromelloses  
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 06/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Provident Pharmaceuticals, LLC 171901445 MANUFACTURE
Revised: 03/2011 Breckenridge Pharmaceutical, Inc.