1fd16b06-0c3e-4a30-ae6a-7b1632189c20

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
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.

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
  • 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)

Description

Guaifenesin 400 mg

Principal Display Panel

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.

Inactive Ingredients:

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

Questions Or Comments?

1-203-861-0005

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

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.

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
  • 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)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.

Inactive Ingredients: (Inactive ingredients:)

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

Questions Or Comments? (Questions or comments?)

1-203-861-0005

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