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Mucinex by Reckitt Benckiser LLC

Dosage form: tablet, extended release
Ingredients: Guaifenesin 600mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-008

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
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 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.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

NDC 63824-008-32

Mucinex®
600 mg guaifenesin
extended-release bi-layer tablets
EXPECTORANT

12
HOUR

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS

MUCINEX 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-008
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITE (blue and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-008-361 BLISTER PACK in 1 CARTON
16 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63824-008-321 BLISTER PACK in 1 CARTON
220 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:63824-008-342 BLISTER PACK in 1 CARTON
320 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
4NDC:63824-008-693 BLISTER PACK in 1 CARTON
420 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
5NDC:63824-008-274 BLISTER PACK in 1 CARTON
518 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
6NDC:63824-008-155 BLISTER PACK in 1 CARTON
620 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
7NDC:63824-008-7424 POUCH in 1 CARTON
7NDC:63824-008-732 TABLET, EXTENDED RELEASE in 1 POUCH
8NDC:63824-008-50500 TABLET, EXTENDED RELEASE in 1 BOTTLE
9NDC:63824-008-722 TABLET, EXTENDED RELEASE in 1 POUCH
10NDC:63824-008-864 BLISTER PACK in 1 CARTON
1017 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
11NDC:63824-008-242 BLISTER PACK in 1 CARTON
1112 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128207/03/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 08/2016
 
Reckitt Benckiser LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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