Guaifenesin 400 Mg And Dextromethorphan Hydrobromide 20 Mg Softgelatin Capsules

Guaifenesin 400 Mg And Dextromethorphan Hydrobromide 20 Mg Softgelatin Capsules
SPL v1
SPL
SPL Set ID 33d4d595-f77d-3e70-e063-6294a90a482b
Route
ORAL
Published
Effective Date 2025-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Glycerin Water Polyethylene Glycol 400 Gelatin Povidone K30 Sorbitol Propylene Glycol

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: yellow Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-11

Description

Guaifenesin USP 400mg Dextromethorphan HBr USP 20mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration

Directions

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use
Description

Guaifenesin USP 400mg Dextromethorphan HBr USP 20mg

Section 50565-1

Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • cough lasts for more than 7 days,recurs, or is accompanied by fever, rash, or persistent headache .

These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • cough accompained by excessive phlegm(mucus)
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
Section 50570-1

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6

Inactive ingredients

gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

Section 53414-9

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

Section 55105-1

Purposes

Expectorant

Cough suppressant

Section 60561-8

Other information

  • store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
  • Keep in dry place and do not expose to heat
Bulk Package Label

When Using This Product
  • do not exceed recommended dosage
  • do not use for more than 7 days
Active Ingredient (in Each Soft Gelatin Capsule)

Guaifenesin USP 400mg

Dextromethorphan HBr USP 20mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
  • adults and children 12 years of age and over: take 1 softgel every 4 hours
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts for more than 7 days,recurs, or is accompanied by fever, rash, or persistent headache .

These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough accompained by excessive phlegm(mucus)
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
Section 50570-1 (50570-1)

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6 (51727-6)

Inactive ingredients

gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Expectorant

Cough suppressant

Section 60561-8 (60561-8)

Other information

  • store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
  • Keep in dry place and do not expose to heat
Bulk Package Label (Bulk package label)

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use for more than 7 days
Active Ingredient (in Each Soft Gelatin Capsule) (Active ingredient (in each soft gelatin capsule))

Guaifenesin USP 400mg

Dextromethorphan HBr USP 20mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)