Your browser does not support JavaScript! BIDEX-400 (GUAIFENESIN) TABLET [SJ PHARMACEUTICALS]
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RxNorm Names

BIDEX-400 (guaifenesin) tablet
[SJ Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)

Stop use and ask doctor if cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.

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

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years
of age and over:
1 tablet every 4 hours, not to
exceed 6 tablets in 24 hours.
Children under 12 years of age:
consult a doctor.
·Take with a full glass of water

Other information

  • Tamper-evident by foil seal under cap.  Do not use if foil seal is broken or missing
  • Store between 20°-25°C (68°-77°F).
  • Supplied in a tight, light-resistant container with a child-resistant cap.
  • Bidex-400 Tablets are white to off white, biconex, capsule shaped tablets, debossed "649" bisect "649" on one side and plain on the other side.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.  May also contain sodium starch glycolate.

Questions or comments?

1 (877) 604-7575

Distributed by:
SJ Pharmaceuticals
4200 North Parkway NW, Bldg. 12
Atlanta, GA  30327

Rev. 10/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel for 100 tablets label:

NDC 24839-777-01

BIDEX®-400
TABLETS

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

Expectorant

CONTENTS:  100 Tablets

SJP

SJ PHARMACEUTICALS


BIDEX-400 Tablets Packaging

BIDEX-400 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24839-777
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide 
Croscarmellose Sodium 
Hypromelloses 
Maltodextrin 
Povidones 
Cellulose, Microcrystalline 
Stearic Acid 
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeCAPSULESize15mm
FlavorImprint Code 649;649
Contains    
Packaging
#Item CodePackage Description
1NDC:24839-777-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/09/2012
Labeler - SJ Pharmaceuticals (845662720)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIBusiness Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(24839-777)

Revised: 11/2012
Document Id: 0c51a0bb-4771-40ba-916d-e8c6d8596083
Set id: 41e795d8-755a-41d0-b1ce-804334559e09
Version: 1
Effective Time: 20121109
 
SJ Pharmaceuticals

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