SPL v1
SPL
SPL Set ID 1be2a8b4-b010-4ad3-aa23-c8e4909681c8
Route
ORAL
Published
Effective Date 2025-09-26
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 Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G400 Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-26
Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses
  • Temporary symptomatic relief from congested chests and cough.
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.

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, Polyvinyl Pyrroliidone (PVPK30), Collidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

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.

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 (1-800-222-1222) right away.

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

Principal Display Panel 60's Count

Principal Display Panel 200's Count

Principal Display Panel 300's Count

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).

Structured Label Content

Uses
  • Temporary symptomatic relief from congested chests and cough.
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.

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, Polyvinyl Pyrroliidone (PVPK30), Collidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 Caplet) (Active ingredient (in each caplet))

Guaifenesin 400 mg

Principal Display Panel 60's Count (Principal Display Panel-60's Count)

Principal Display Panel 200's Count (Principal Display Panel-200's Count)

Principal Display Panel 300's Count (Principal Display Panel-300's Count)

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 excessive phlegm (mucus).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.610954 · Updated: 2026-03-14T23:10:18.112618