drug facts

drug facts
SPL v3
SPL
SPL Set ID a164c2a1-5a27-4e16-aea2-48267c2b5c0c
Route
oral
Published
Effective Date 2021-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg)
Inactive Ingredients
maltodextrin stearic acid silicon dioxide povidone k30 magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: PH063 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
otc monograph final active Since 2021-02-17
Purpose

Expectorant3

Description

Active ingredient (per tablet) Guaifenesin  400mg

Medication Information

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)
Active Ingredient



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
Purpose

Expectorant3

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, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.

Description

Active ingredient (per tablet) Guaifenesin  400mg

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.

Structured Label Content

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)
Active Ingredient (55106-9)



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
Purpose

Expectorant3

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, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, 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 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:32.922672 · Updated: 2026-03-14T22:59:33.610229