Mucinex ®

Mucinex ®
SPL v7
SPL
SPL Set ID a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b
Route
ORAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: Mucinex;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2012-07-03
Description

Drug Facts

Purpose

Expectorant

How Supplied

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg NDC 63629-7886-1: 20 Tablets in a BLISTER PACK NDC 63629-7886-2: 40 Tablets in a BLISTER PACK Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Expectorant

How Supplied

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

  • NDC 63629-7886-1: 20 Tablets in a BLISTER PACK
  • NDC 63629-7886-2: 40 Tablets in a BLISTER PACK

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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
Do Not Use
  • for children under 12 years of age
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

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

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.
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)
Active Ingredient (in Each Extended Release Bi Layer Tablet)

Guaifenesin 600 mg

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Expectorant

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
Do Not Use (Do not use)
  • for children under 12 years of age
Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

How Supplied (HOW SUPPLIED)

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

  • NDC 63629-7886-1: 20 Tablets in a BLISTER PACK
  • NDC 63629-7886-2: 40 Tablets in a BLISTER PACK

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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)
Active Ingredient (in Each Extended Release Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 600 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:06.190971 · Updated: 2026-03-14T23:02:58.626725