MUCUS RELIEF- guaifenesin 200 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, 200 mg

Active ingredient (in each tablet)

Guaifenesin 200 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, FD&C RED#40(Al-lake), 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 200 mg...Expectorant
NDC- 54738-980-01... 100 CAPLETS

IMG_4689

MUCUS RELIEF 
guaifenesin 200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-980
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorredScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code AP;151
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-980-01100 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(54738-980)

Revised: 8/2018
Document Id: 73570295-8ab7-1c19-e053-2991aa0a6b82
Set id: e20927a1-d402-48c1-ba00-0745ddd0a0e7
Version: 3
Effective Time: 20180813
 
Richmond Pharmaceuticals, Inc.