Guaifenesin 400 Mg Caplets

Guaifenesin 400 Mg Caplets
SPL v11
SPL
SPL Set ID d60a3e9d-e88e-3b19-e053-2995a90a3e8d
Route
ORAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Maltodextrin Povidone K30 Microcrystalline Cellulose Croscarmellose Sodium Water Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G400 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-18
Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses
  • Temporary symptomatic relief from congested chests and cough.
Section 53414-9

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

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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).
Directions
  • Adults and children 12 years of age and over: take 1 caplet a day.
  • Children under 12 years:Do not use.
  • Do not exceed 4 doses in 24 hours.
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.
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

Questions Or Comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

When Using This Product
  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.
Stop Use and Ask A Doctor If

cough lasts for more than 7 days please consult your physician or healthcare provider.

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.

Principal Display Panel 60 Count

Principal Display Panel 200 Count

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

Structured Label Content

Uses
  • Temporary symptomatic relief from congested chests and cough.
Section 53414-9 (53414-9)

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

Purpose

Expectorant

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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).
Directions
  • Adults and children 12 years of age and over: take 1 caplet a day.
  • Children under 12 years:Do not use.
  • Do not exceed 4 doses in 24 hours.
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.
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

When Using This Product (When using this product)
  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts for more than 7 days please consult your physician or healthcare provider.

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.

Principal Display Panel 60 Count (Principal Display Panel-60 count)

Principal Display Panel 200 Count (Principal Display Panel-200 count)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Guaifenesin 400 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.888367 · Updated: 2026-03-14T23:09:03.764166