MUCINEX D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release 
REMEDYREPACK INC.

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Mucinex®D

Drug Facts

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

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other information

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20-25°C (68-77°F)

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Mucinex D

GENERIC: Guaifenesin and Pseudoephedrine Hydrochloride

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0523-0

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: Mucinex;600

PACKAGING: 18 in 1 BLISTER PACK

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Pseudoephedrine Hydrochloride 60mg in 1
  • Guaifenesin 600mg in 1

INACTIVE INGREDIENT(S):

  • carbomer homopolymer type B (allyl pentaerythritol crosslinked)
  • FD&C yellow NO. 6
  • aluminum oxide
  • HYPROMELLOSE, UNSPECIFIED
  • magnesium stearate
  • MICROCRYSTALLINE CELLULOSE

MM1

MUCINEX D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0523(NDC:63824-057)
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)  
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
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0523-01 in 1 CARTON05/11/201710/13/2023
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02158505/11/201710/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
 
REMEDYREPACK INC.