MUCINEX D  MAXIMUM STRENGTH- guaifenesin and pseudoephedrine hydrochloride tablet, extended release 
RB Health (US) LLC

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Mucinex® D
Maximum Strength

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purposes
Guaifenesin 1200 mgExpectorant
Pseudoephedrine HCl 120 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.

Directions

Other information

Inactive ingredients

carbomer homopolymer type B; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

MAXIMUM STRENGTH

NDC 63824-041-24

Mucinex®D
1200 mg guaifenesin & 120 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT
& NASAL DECONGESTANT

12
HOUR®

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

24
EXTENDED-RELEASE
BI-LAYER TABLETS

Principal Display Panel - 24 Tablet Blister Pack Carton
MUCINEX D   MAXIMUM STRENGTH
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31)  
FD&C yellow NO. 6 (UNII: H77VEI93A8)  
aluminum oxide (UNII: LMI26O6933)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGE, WHITEScoreno score
ShapeOVALSize22mm
FlavorImprint Code Mucinex;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-041-242 in 1 CARTON06/26/2012
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-041-7124 in 1 CARTON06/26/201207/10/2017
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:63824-041-363 in 1 CARTON06/26/201209/12/2017
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-041-121 in 1 CARTON01/01/2020
412 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158506/26/2012
Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022
Document Id: 8d9f4400-2441-44d9-9777-3a62d6dfab92
Set id: d9264518-2f2c-498f-b733-6f3397336a01
Version: 9
Effective Time: 20220111
 
RB Health (US) LLC