GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE- guaifenesin and pseudoephedrine hydrochloride tablet, extended release 
PUBLIX SUPER MARKETS, INC

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Guaifenesin and Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Guaifenesin 600 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

Uses

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

When using this product

  • do not use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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 right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

NDC 41415-994-36

12-HOUR

mucusD

GUAIFENESIN 600 mg &
PSEUDOEPHEDRINE HCl 60 mg
EXTENDED-RELEASE TABLETS

EXPECTORANT & NASAL
DECONGESTANT

12 Hour

36
EXTENDED-RELEASE
TABLETS

Compare to the active
ingredients of Mucinex® D

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-994
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code 058
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41415-994-181 in 1 CARTON04/07/2022
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41415-994-362 in 1 CARTON04/07/2022
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/07/2022
Labeler - PUBLIX SUPER MARKETS, INC (006922009)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(41415-994)

Revised: 4/2022
Document Id: a36d0524-b1d7-4daf-a62e-54f63168b0cd
Set id: c857bcd9-6696-40d5-93c0-65097598cd4b
Version: 2
Effective Time: 20220408
 
PUBLIX SUPER MARKETS, INC