MUCUS RELIEF- guaifenesin 400 mg tablet 
Advance Pharmaceutical 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:

Inactive ingredients

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

Questions or Comments

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

Guaifenesin 400 mg... Expectorant

NDC-17714-152-01 100 tabs

gaui 152-01

MUCUS RELIEF 
guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-152
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:17714-152-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2016
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-152)

Revised: 10/2017
Document Id: 5cc992c7-a1b3-46be-e053-2991aa0a1f8f
Set id: 5b78bbe9-806c-443f-bc23-351e5342355f
Version: 2
Effective Time: 20171030
 
Advance Pharmaceutical Inc.