Guaifed Dm

Guaifed Dm
SPL v4
SPL
SPL Set ID 396bf716-0f61-9563-e063-6394a90a171b
Route
ORAL
Published
Effective Date 2025-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Menthol Methylparaben Propylene Glycol Water Sodium Citrate Citric Acid Sucralose Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Active Ingredients: ( per 10ml= 2 teaspoonfuls) Purpose Guaifenesin 200 mg ................................................................... Expectorant Dextromethorphan 20mg............................................................ Cough Suppresant


Medication Information

Warnings and Precautions

Warnings

  • Do not use:if you are now takin a prescription monoamine oxidase inhibidor (MAOI) (certain drugs for deression, psychiatric or emotional conditions, or Parkinson's disease, or for two weeks after stoping the MAOI drug. If you do not know if nyour prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage

Uses:

  • Temporarily relieves coiugh due to minor throat and bronchial irritation
  • Helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive.
Dosage and Administration

Directions

  • do not exceed recommended dosage
  • take every 4 hours as needed, or as directed by doctor
  • do not take more than 6 doses in 24 hours
Age Dose
adults and children 12 years and over 10 mL (2 teaspoonfuls)
children under 12 years Do not use
Description

Active Ingredients: ( per 10ml= 2 teaspoonfuls) Purpose Guaifenesin 200 mg ................................................................... Expectorant Dextromethorphan 20mg............................................................ Cough Suppresant

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back 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 that occurs with too much phlegm (mucus)
  • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 51727-6

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose

Section 53413-1

Questions or Comments?305-592-9216 or [email protected]

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Cough Suppresant

Section 55106-9

Active Ingredients:( per 10ml= 2 teaspoonfuls) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Dextromethorphan 20mg............................................................ Cough Suppresant

Section 60561-8

Other information

  • each 10 mL contains:potassium 20 mg
  • TAMPER - EVIDENT FEATURE:Do not use if foil seal over bottle opening is torn, broken or missing.
  • store between 15° - 30°C (59° - 86°F).
  • Protect from freezing
  • protect from light

Guaifed Dm


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily relieves coiugh due to minor throat and bronchial irritation
  • Helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive.
Dosage and Administration (34068-7)

Directions

  • do not exceed recommended dosage
  • take every 4 hours as needed, or as directed by doctor
  • do not take more than 6 doses in 24 hours
Age Dose
adults and children 12 years and over 10 mL (2 teaspoonfuls)
children under 12 years Do not use
Warnings and Precautions (34071-1)

Warnings

  • Do not use:if you are now takin a prescription monoamine oxidase inhibidor (MAOI) (certain drugs for deression, psychiatric or emotional conditions, or Parkinson's disease, or for two weeks after stoping the MAOI drug. If you do not know if nyour prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of 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 more than 7 days, comes back 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 that occurs with too much phlegm (mucus)
  • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 51727-6 (51727-6)

Inactive Ingredients:

Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose

Section 53413-1 (53413-1)

Questions or Comments?305-592-9216 or [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Cough Suppresant

Section 55106-9 (55106-9)

Active Ingredients:( per 10ml= 2 teaspoonfuls) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Dextromethorphan 20mg............................................................ Cough Suppresant

Section 60561-8 (60561-8)

Other information

  • each 10 mL contains:potassium 20 mg
  • TAMPER - EVIDENT FEATURE:Do not use if foil seal over bottle opening is torn, broken or missing.
  • store between 15° - 30°C (59° - 86°F).
  • Protect from freezing
  • protect from light

Guaifed Dm (Guaifed DM)


Advanced Ingredient Data


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