SPL v1
SPL
SPL Set ID 1fd16b06-0c3e-4a30-ae6a-7b1632189c20
Route
ORAL
Published
Effective Date 2025-05-16
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 Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;152 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
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 passageways of bothersome mucus
Section 42229-5

Manufactured for:

SDA Laboratories, Inc.

New York, NY

Section 50565-1

Keep out of reach of children.

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

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.

Directions
  • take with full glass of water
  • not intended for use in children under 12 years of age
Adults and children 12 years

of age and over
  • take 1 caplet, 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 room temperature 15°-30°C (59°-86°F)

Inactive Ingredients:

cellulose, magnesium stearate, maltodextrin, povidone, silica, stearic acid.

Questions Or Comments?

1-203-861-0005

Principal Display Panel

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageways of bothersome mucus
Section 42229-5 (42229-5)

Manufactured for:

SDA Laboratories, Inc.

New York, NY

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.

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)

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.

Directions
  • take with full glass of water
  • not intended for use in children under 12 years of age
Adults and children 12 years

of age and over
  • take 1 caplet, 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 room temperature 15°-30°C (59°-86°F)

Inactive Ingredients: (Inactive ingredients:)

cellulose, magnesium stearate, maltodextrin, povidone, silica, stearic acid.

Questions Or Comments? (Questions or comments?)

1-203-861-0005

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Guaifenesin 400 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.746154 · Updated: 2026-03-14T23:09:10.710567