MUCUS RELIEF- guaifenesin 400 mg tablet 
Richmond 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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Guaifenesin Caplets, 400 mg

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

Warnings

ask a doctor before use if you have

KEEP OUT OF REACH OF CHILDREN 

In case of overdose, get medical help or contact a Poison Control Center right away.

IN CASE OF PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

stop use and ask a doctor

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

Directions:

OTHER  INFORMATION

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Guaifenesin 400 mg...Expectorant
NDC- 54738-981-30... 30 CAPLETS

IMG_4690

NDC- 54738-981-60... 60 CAPLETS

IMG_4691

MUCUS RELIEF 
guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-981
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code AP;152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-981-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
2NDC:54738-981-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2016
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-981)

Revised: 10/2017
Document Id: 5cc3bf1b-4684-6a53-e053-2a91aa0abfa6
Set id: 26924bee-32cc-4499-beb0-2650ff8eb1da
Version: 2
Effective Time: 20171030
 
Richmond Pharmaceuticals, Inc.