MUCUS RELIEF- guaifenesin 400 mg tablet 
TWIN MED LLC

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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Mucus Relief - Guaifenesin 400 mg Caplets

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

Warnings

ask a doctor before use if you have

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs 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 (1 ·800-222-1222) immediately.

Directions:

Other information

Inactive ingredients

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions or Comments

Call 1-844-912·4012

Principal Display Panel

DD NDT USE IF PRINTED SEALUNDER CAP IS BRDKEN OR MISSING

Dlsbibuted by: Procure Products
11333 Greenstone Ave,
Santa Fe Springs, CA 90670

Guai 400

MUCUS RELIEF 
guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code G400
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-311-03300 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2022
Labeler - TWIN MED LLC (009579330)

Revised: 3/2023
Document Id: f7f18eb7-a4bb-b7f6-e053-6394a90a0f74
Set id: e31bd69f-97ab-9d99-e053-2995a90a580e
Version: 2
Effective Time: 20230328
 
TWIN MED LLC