SPL v4
SPL
SPL Set ID d6aa1493-bc22-a318-e053-2995a90a6381
Route
ORAL
Published
Effective Date 2025-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Croscarmellose Sodium Maltodextrin Povidone K30 Silicon Dioxide Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-22

Description

Guaifenesin 200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 200 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.

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)

When using this product

  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.

Stop use and ask a doctor ifcough lasts for more than 7 days please consult your physicain or healthcare provider.

Directions
  • Adults and children 12 years of age and over:take 1 tablet 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 use. 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrrolidone (PVPK30), Colloidal 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

Principal Display Panel

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 Tablet)

Guaifenesin 200 mg


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.

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)

When using this product

  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.

Stop use and ask a doctor ifcough lasts for more than 7 days please consult your physicain or healthcare provider.

Directions
  • Adults and children 12 years of age and over:take 1 tablet 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 use. 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrrolidone (PVPK30), Colloidal 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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 Tablet) (Active ingredient (in each tablet))

Guaifenesin 200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)