Mucus Relief- Guaifenesin 400 Mg Tablet

Mucus Relief- Guaifenesin 400 Mg Tablet
SPL v1
SPL
SPL Set ID 729ab412-f30b-4ad1-9d8f-1a5e1c48b118
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Microcrystalline Cellulose Povidone, Unspecified Croscarmellose Sodium Magnesium Stearate Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-16

Description

Guaifenesin 400 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

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

This product is not manufcatured or distributed by Reckitt Benckiser's , owner of the Registered Trademark MUCINEX®

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4

Section 53414-9

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

Warnings

Do not use: for children under 12 years of age

Directions
  • Adults and children 12 years and older:take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years:do not use
Other Information
  • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • Keep in a dry place and do not expose to heat
  • Read all product information before using
Inactive Ingredients

Microcrystalline Cellulose, Polyvinyl pyrrolidone (PVPK30), Croscarmellose Sodium, Magnesium stearate, Colloidal silicon dioxide, purified water

Questions Or Comments ?

Call +1 (732) 994-2808 or email [email protected]

Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient (in Each Tablet)

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Structured Label Content

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

This product is not manufcatured or distributed by Reckitt Benckiser's , owner of the Registered Trademark MUCINEX®

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Expectorant

Warnings

Do not use: for children under 12 years of age

Directions
  • Adults and children 12 years and older:take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years:do not use
Other Information (Other information)
  • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • Keep in a dry place and do not expose to heat
  • Read all product information before using
Inactive Ingredients (Inactive ingredients)

Microcrystalline Cellulose, Polyvinyl pyrrolidone (PVPK30), Croscarmellose Sodium, Magnesium stearate, Colloidal silicon dioxide, purified water

Questions Or Comments ? (Questions or Comments ?)

Call +1 (732) 994-2808 or email [email protected]

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg

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 is accompanied by excessive phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)