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Mucinex Maximum Strength Prescribing Information

Package insert / product label
Generic name: guaifenesin
Dosage form: tablet, extended release
Drug class: Expectorants

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Drug Facts

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

Guaifenesin 1200 mg

Purpose

Expectorant

Indications and Usage for Mucinex Maximum Strength

  • 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.

Mucinex Maximum Strength Dosage and Administration

  • 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

Storage and Handling

  • store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue no. 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: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

NDC 63824-023-35

MAXIMUM STRENGTH

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

EXPECTORANT

12
HOUR®

🗸
Relieves Chest Congestion
🗸
Thins and Loosens Mucus
🗸
Immediate and Extended Release

14
EXTENDED-RELEASE
BI-LAYER TABLETS

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton
MUCINEX MAXIMUM STRENGTH
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 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)
Product Characteristics
ColorWHITE (blue and white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-023-071 in 1 CARTON06/11/2015
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-023-351 in 1 CARTON06/26/2012
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-023-362 in 1 CARTON06/26/2012
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-023-484 in 1 CARTON06/26/2012
412 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:63824-023-463 in 1 CARTON06/26/2012
514 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:63824-023-182 in 1 CARTON06/26/201206/15/2022
69 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:63824-023-021 in 1 CARTON07/01/2021
71 in 1 POUCH; Type 0: Not a Combination Product
8NDC:63824-023-564 in 1 CARTON07/01/2021
814 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128206/26/2012
Labeler - RB Health (US) LLC (081049410)

Frequently asked questions

Medical Disclaimer