SPL v1
SPL
SPL Set ID 4e3b910e-fde3-4c2e-942e-df3c1d3d4f89
Route
ORAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G400 Shape: capsule Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

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 passageway of bothersome mucus and make coughs more productive
Section 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

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

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 excessive 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.
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • children under 12 years of age: do not use
Questions?

call toll-free 1-844-912-4012

Other Information
  • store at 20-25°C (68-77°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, stearic acid.

Principal Display Panel

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.

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg


Structured Label Content

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

Distributed by:

BI-MART

Eugene, OR 97402

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

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 excessive 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.
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
  • children under 12 years of age: do not use
Questions?

call toll-free 1-844-912-4012

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, stearic acid.

Principal Display Panel

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)