GUAIFENESIN 400MG- guaifenesin tablet 
Marlex Pharmaceuticals Inc

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Guaifenesin 400mg

GUAIFENESIN400MG TABLETS

MarlexPharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Guaifenesin 400 mg Tablets

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

 

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:

Other Information:

Inactive Ingredients:

Colloidal silicon dioxide, FD&C RED #40(AI-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

PRINCIPAL DISPLAY PANEL

NDC 10135-0682-30
Guaifenesin
400 mg
30 CAPLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0682-30
Guaifenesin
400 mg
30 CAPLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0682-30
Guaifenesin
400 mg
30 CAPLETS

PRINCIPAL DISPLAY PANEL

NDC 10135-0682-60
Guaifenesin
400 mg
60 CAPLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0682-60
Guaifenesin
400 mg
60 CAPLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0682-60
Guaifenesin
400 mg
60 CAPLETS

GUAIFENESIN 400MG 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-682
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Caplet) Size10mm
FlavorImprint Code G400
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-682-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
2NDC:10135-682-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/01/2019
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 11/2023
Document Id: 09400c44-c3ec-3caf-e063-6394a90a063d
Set id: 43ca292e-3128-47fc-9f20-b7e8c8677d4d
Version: 4
Effective Time: 20231103
 
Marlex Pharmaceuticals Inc