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
Purpose

EXPECTORANT

Description

GUAIFENESIN 400MG

Medication Information

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.

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

EXPECTORANT

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

Description

GUAIFENESIN 400MG

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

Active Ingredient (in Each Caplet)

GUAIFENESIN 400MG

Structured Label Content

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.

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

EXPECTORANT

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

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)

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

GUAIFENESIN 400MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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