Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID ad9fde8b-10cd-4778-917d-1ed6b67e5ab1
Route
ORAL
Published
Effective Date 2013-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Maltodextrin Stearic Acid Silicon Dioxide Copovidone Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: PH063 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-01
Description

Active ingredient (per tablet) Guaifenesin  400mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Active ingredient (per tablet) Guaifenesin  400mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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 immediately.

Section 50566-9

Stop use and ask doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition.
Section 51945-4

Section 53414-9

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

Section 55106-9



Active ingredient (per tablet)



Guaifenesin  400mg

Warnings

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)
Directions
  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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 immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)



Active ingredient (per tablet)



Guaifenesin  400mg

Purpose

Expectorant

Warnings

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)
Directions
  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:02.336017 · Updated: 2026-03-14T23:06:18.731306