Gendose - Guaifenesin 400 Mg Caplets (77333-360)

Gendose - Guaifenesin 400 Mg Caplets (77333-360)
SPL v6
SPL
SPL Set ID e7b82ec7-ef23-50c1-e053-2a95a90a662f
Route
ORAL
Published
Effective Date 2022-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G400 Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-02
Description

GUAIFENESIN 400MG

Purpose

EXPECTORANT

Medication Information

Purpose

EXPECTORANT

Description

GUAIFENESIN 400MG

Uses
  • HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS.
  • HELPS MAKE COUGHS MORE PRODUCTIVE
Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

Section 51945-4

Warnings

ASK DOCTOR BEFORE USE IF YOU HAVE:

  • PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
  • COUGH ACCOMPANIED BY EXCESSIVE PHLEGM

WHEN USING THIS PRODUCT

  • DO NOT EXCEED RECOMMENDED DOSAGE
  • DO NOT USE FOR MORE THAN 7 DAYS

STOP USE AND ASK A DOCTOR IS

  • COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Directions
  • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST.
  • CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.
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
Inactive Ingredients

CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE

Active Ingredient (in Each Caplet)

GUAIFENESIN 400MG

Structured Label Content

Uses (USES)
  • HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS.
  • HELPS MAKE COUGHS MORE PRODUCTIVE
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

EXPECTORANT

Warnings (WARNINGS)

ASK DOCTOR BEFORE USE IF YOU HAVE:

  • PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
  • COUGH ACCOMPANIED BY EXCESSIVE PHLEGM

WHEN USING THIS PRODUCT

  • DO NOT EXCEED RECOMMENDED DOSAGE
  • DO NOT USE FOR MORE THAN 7 DAYS

STOP USE AND ASK A DOCTOR IS

  • COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Directions (DIRECTIONS)
  • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST.
  • CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.
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
Inactive Ingredients (INACTIVE INGREDIENTS)

CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE

Active Ingredient (in Each Caplet) (ACTIVE INGREDIENT (IN EACH CAPLET))

GUAIFENESIN 400MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:27.616134 · Updated: 2026-03-14T23:09:13.832086