gc 794

gc 794
SPL v7
SPL
SPL Set ID bb72de5d-d3c0-42fc-ae52-a3ad95214af5
Route
oral
Published
Effective Date 2013-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg)
Inactive Ingredients
cellulose, microcrystalline magnesium stearate maltodextrin povidone silicon dioxide sodium starch glycolate type a potato stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL272 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
otc monograph drug active Since 2004-01-01 Until 2013-08-01
Purpose

Expectorant

Description

Guaifenesin 400 mg

Medication Information

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)

Stop use and ask a doctor if

  • cough lasts more than 7 days or comes back

  • cough occurs with fever, rash or persistent headache
  • these could be signs of a serious illness.

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient

Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageways of bothersome mucus
Purpose

Expectorant

Directions
  • take with full glass of water

  • do not exceed recommended dose
adults and children 12 years

of age and over

1 tablet, every 4 hours, while

symptoms persist • do not

exceed 6 doses in 24 hours

children under 12 years of age

do not use

Other Information

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

• store at 20°-25°C(68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F)

Inactive Ingredients

cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.

Description

Guaifenesin 400 mg

Section 50565-1

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

Package Label

Questions Or Comments?

1-800-540-3765

Structured Label Content

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)

Stop use and ask a doctor if

  • cough lasts more than 7 days or comes back

  • cough occurs with fever, rash or persistent headache
  • these could be signs of a serious illness.

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient (Active ingredient (in each tablet))

Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageways of bothersome mucus
Purpose

Expectorant

Directions
  • take with full glass of water

  • do not exceed recommended dose
adults and children 12 years

of age and over

1 tablet, every 4 hours, while

symptoms persist • do not

exceed 6 doses in 24 hours

children under 12 years of age

do not use

Other Information (Other information)

• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

• store at 20°-25°C(68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F)

Inactive Ingredients (Inactive ingredients)

cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.

Section 50565-1 (50565-1)

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

Package Label (package Label)

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:35.938541 · Updated: 2026-03-14T23:05:26.862879