GUAIFENESIN 400MG- guaifenesin tablet 
Marlex Pharmaceuticals Inc

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Guaifenesin 400mg

GUAIFENESIN400MG CAPLETS

MarlexPharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 400mg

Purpose

Expectorant

Guaifenesin 400 mg Caplets

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, comes back or is accompanied by fever, rash, or persistent headache. These 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:

Maltodextrin, Povidone, Silicon Dioxide, Stearic acid.

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/24 AA

PRINCIPAL DISPLAY PANEL

NDC 10135-0790-30
Guaifenesin
400 mg
30 CAPLETS

790-30

PRINCIPAL DISPLAY PANEL

NDC 10135-0790-60
Guaifenesin
400 mg
60 CAPLETS

790-60

GUAIFENESIN 400MG 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-790
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)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeCAPSULE (Caplet) Size14mm
FlavorImprint Code C16
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-790-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
2NDC:10135-790-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/01/2024
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 3/2024
Document Id: 13f4d349-3c72-2c30-e063-6394a90a9ff8
Set id: 13f4db4e-687e-9d7b-e063-6294a90ab088
Version: 1
Effective Time: 20240301
 
Marlex Pharmaceuticals Inc