Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e
Route
ORAL
Published
Effective Date 2021-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Maltodextrin Stearic Acid Silicon Dioxide Microcrystalline Cellulose Magnesium Stearate Povidone K30 Povidone K90

Identifiers & Packaging

Pill Appearance
Imprint: PH063 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-27
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 51945-4

DISTRIBUTED BY THE KROGER COMPANY

CINCINNATI OHIO 45202

REV 2/21 GUAF030CT0

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 Directions

store at 15°-30°C (59°-86°F)

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin,  Stearic acid, Povidone K30, Povidone 90F

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.

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control

Center immediately.

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 51945-4 (51945-4)

DISTRIBUTED BY THE KROGER COMPANY

CINCINNATI OHIO 45202

REV 2/21 GUAF030CT0

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 Directions (Other directions)

store at 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin,  Stearic acid, Povidone K30, Povidone 90F

Stop Use and Ask Doctor If (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.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control

Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:53.500943 · Updated: 2026-03-14T23:06:01.213422