Guaifenesin Caplets, 400 Mg

Guaifenesin Caplets, 400 Mg
SPL v2
SPL
SPL Set ID 26924bee-32cc-4499-beb0-2650ff8eb1da
Route
ORAL
Published
Effective Date 2017-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AP;152 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-03-01
Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive
Section 51945-4



Guaifenesin 400 mg...Expectorant

NDC- 54738-981-30... 30 CAPLETS

NDC- 54738-981-60... 60 CAPLETS

Warnings

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 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 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Stop Use and Ask A Doctor

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

Keep Out of Reach of Children 

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg

In Case of Pregnancy Or Breast Feeding Section

ask a health professional before use

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus and make cough more productive
Section 51945-4 (51945-4)



Guaifenesin 400 mg...Expectorant

NDC- 54738-981-30... 30 CAPLETS

NDC- 54738-981-60... 60 CAPLETS

Purpose

Expectorant

Warnings

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 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 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions Or Comments (Questions or Comments)

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Stop Use and Ask A Doctor (stop use and ask a doctor)

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

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 right away.

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

Guaifenesin 400 mg

In Case of Pregnancy Or Breast Feeding Section (IN CASE OF PREGNANCY OR BREAST FEEDING SECTION)

ask a health professional before use

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.096173 · Updated: 2026-03-14T22:54:52.931560