Guaifenesin 400 Tablets

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 TypeHUMAN OTC DRUGNDC Product Code (Source)51991-606
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium 
Hypromelloses 
Magnesium Stearate 
Maltodextrin 
Cellulose, Microcrystalline 
Povidone 
Silicon Dioxide 
Stearic Acid 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVAL (Capsule Shaped) Size17mm
FlavorImprint Code B;606
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-606-01100 TABLET In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/200806/30/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Provident Pharmaceuticals, LLC171901445MANUFACTURE
Revised: 03/2011Breckenridge Pharmaceutical, Inc.