GUAIFENESIN- guaifenesin tablet 
Pharbest Pharmaceuticals, Inc.

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.

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Drug Facts

Active Ingredient (in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Uses

Warnings

Ask doctor before use if you have

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of serious illness.

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 (1-800-222-1222).

Directions

  • take with a full glass of water
  • this product can be administered without regard for the timing of the meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

adults and children 12 years of age and over

take 1 tablet every 4 hours as needed

children 6 to under 12 years of age

take ½ tablet every 4 hours as needed

children under 6 years of age

consult a doctor

Other information

Inactive ingredients

magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid.

Questions?

Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

PHARBEST 

NDC 16103-379-04

Manufactured in the USA

Immediate Release

*COMPARE TO the active ingredient in MUCINEX® Tablets

PHARBINEX

Guaifenesin 400mg each

Expectorant

30 TABLETS

Pharbinex Tablet Product Label

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-379
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size17mm
FlavorImprint Code PH063
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-379-041 in 1 CARTON05/01/2018
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-379) , analysis(16103-379) , pack(16103-379) , label(16103-379)

Revised: 1/2021
Document Id: d0fe27fa-2318-4998-a3f6-c973f357255f
Set id: 0bf70fb4-d3c8-476d-b864-4eadc697a7d8
Version: 1
Effective Time: 20210111
 
Pharbest Pharmaceuticals, Inc.