MUCUS RELIEF CHEST CONGESTION- guaifenesin tablet, film coated 
Unit Dose Services

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.

----------

Major 44-532

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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) right away.

Directions

Other information

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

(800) 616-2471

HOW SUPPLIED

Product: 50436-6815

NDC: 50436-6815-1 60 TABLET, FILM COATED in a BOTTLE

MUCUS RELIEF CHEST CONGESTION (GUAIFENESIN) TABLET, FILM COATED

Label Image
MUCUS RELIEF CHEST CONGESTION 
guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-6815(NDC:0904-6815)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 44;532
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-6815-160 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/31/2018
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIBusiness Operations
Unit Dose Services831995316REPACK(50436-6815) , RELABEL(50436-6815)

Revised: 7/2019
Document Id: f474b90a-07fa-4fa6-9316-e2748114bd5e
Set id: ca124200-c99f-4970-be21-812cf13f3467
Version: 2
Effective Time: 20190718
 
Unit Dose Services