Mucinex Maximum Strength

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-023

MAXIMUM STRENGTH
Mucinex®
EXPECTORANT

Drug Facts

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

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 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

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Carton

MAXIMUM STRENGTH

NDC 63824-023-36

Mucinex®
1200 mg guaifenesin
extended-release bi-layer tablets
EXPECTORANT

12
HOUR

✓ Relieves Chest Congestion

✓ Thins And Loosens Mucus

28 extended-release bi-layer tablets

MUCINEX   MAXIMUM STRENGTH
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin1200 mg
Inactive Ingredients
Ingredient NameStrength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) 
FD&C blue no. 1 
aluminum oxide 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
Product Characteristics
ColorWHITE (blue and white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-023-362 BLISTER PACK in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63824-023-352 BLISTER PACK in 1 CARTON
27 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:63824-023-281 BOTTLE in 1 CARTON
328 TABLET, EXTENDED RELEASE in 1 BOTTLE
4NDC:63824-023-431 BOTTLE in 1 BLISTER PACK
442 TABLET, EXTENDED RELEASE in 1 BOTTLE
5NDC:63824-023-451 BOTTLE in 1 BLISTER PACK
544 TABLET, EXTENDED RELEASE in 1 BOTTLE
6NDC:63824-023-141 BOTTLE in 1 CARTON
614 TABLET, EXTENDED RELEASE in 1 BOTTLE
7NDC:63824-023-7124 POUCH in 1 CARTON
71 TABLET, EXTENDED RELEASE in 1 POUCH
8NDC:63824-023-484 BLISTER PACK in 1 CARTON
812 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
9NDC:63824-023-463 BLISTER PACK in 1 CARTON
914 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128206/26/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 07/2012
 
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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