Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 412f3459-4c22-4822-86bd-011fc3e91ca6
Route
ORAL
Published
Effective Date 2014-04-04
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 Povidone K90 Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: PH063 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-27
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 (1-800-222-1222).

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. Do not exceed 6 tablets in 24 hours.
  • Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: consult a doctor    
Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

magnesium stearate, microcrystalline cellulose, silicon dioxide, povidone K30, povidone 90F, maltodextrin, 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 (1-800-222-1222).

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. Do not exceed 6 tablets in 24 hours.
  • Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours.
  • Children under 6 years of age: consult a doctor    
Other Information

store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:53.528451 · Updated: 2026-03-14T23:06:01.213422