BIDEX-400 - guaifenesin tablet 
SJ Pharmaceuticals

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.



Drug Facts

Active ingredient
(in each immediate release tablet)
Guaifenesin 400 mg




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


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.


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

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


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


CONTENTS:  100 Tablets



BIDEX-400 Tablets Packaging

guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24839-777
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Hypromelloses (UNII: 3NXW29V3WO)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Povidones (UNII: FZ989GH94E)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape CAPSULE Size 15mm
Flavor Imprint Code 649;649
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24839-777-01 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/09/2012
Labeler - SJ Pharmaceuticals (845662720)
Registrant - Pernix Manufacturing, LLC (078641814)
Name Address ID/FEI Business Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(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