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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 Mar 22, 2023.

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

  • 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

MUCINEX MAXIMUM STRENGTH
guaifenesin tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-023
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 1200 mg
Inactive Ingredients
Ingredient Name Strength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
FD&C blue no. 1
aluminum oxide
hypromellose, unspecified
magnesium stearate
microcrystalline cellulose
Product Characteristics
Color WHITE (blue and white) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code Mucinex;1200
Contains
Packaging
# Item Code Package Description
1 NDC:63824-023-07 1 BLISTER PACK in 1 CARTON
1 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 NDC:63824-023-35 1 BLISTER PACK in 1 CARTON
2 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3 NDC:63824-023-36 2 BLISTER PACK in 1 CARTON
3 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
4 NDC:63824-023-48 4 BLISTER PACK in 1 CARTON
4 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
5 NDC:63824-023-46 3 BLISTER PACK in 1 CARTON
5 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
6 NDC:63824-023-18 2 BLISTER PACK in 1 CARTON
6 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
7 NDC:63824-023-02 1 POUCH in 1 CARTON
7 1 TABLET, EXTENDED RELEASE in 1 POUCH
8 NDC:63824-023-56 4 BLISTER PACK in 1 CARTON
8 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 06/26/2012
Labeler - RB Health (US) LLC (081049410)
RB Health (US) LLC

Frequently asked questions

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