MUCINEX- guaifenesin tablet, extended release 
REMEDYREPACK INC.

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Mucinex ®

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 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

Do not use

  • for children under 12 years of age

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with 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 the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue #1 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

GENERIC: Guaifenesin

DOSAGE: TABLET, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0228-0

NDC: 70518-0228-1

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: Mucinex;600

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 20 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Guaifenesin 600mg in 1

INACTIVE INGREDIENT(S):

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
  • FD&C BLUE NO. 1
  • ALUMINUM OXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

MM2

MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0228(NDC:63824-008)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0228-020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/201704/22/2020
2NDC:70518-0228-120 in 1 BLISTER PACK; Type 0: Not a Combination Product02/27/201710/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128202/16/201710/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 079bd0fe-506d-a652-e063-6294a90a155e
Set id: 6356db25-f666-43b2-a14a-a999acf30f1f
Version: 10
Effective Time: 20231013
 
REMEDYREPACK INC.