SPL v1
SPL
SPL Set ID c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa
Route
ORAL
Published
Effective Date 2022-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Hydroxyethyl Cellulose, Unspecified Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-12-01

Description

Active Ingredients (in each 20 mL) Dextromethorphan HBr 20mg Guaifenesin 400 mg


Medication Information

Warnings and Precautions

Warnings

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.

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 drain bronchial tubes
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = mililiters
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Description

Active Ingredients (in each 20 mL) Dextromethorphan HBr 20mg Guaifenesin 400 mg

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.

When using this prodcut, do not use more than directed.

Section 50569-3

Ask a doctor before us if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking,asthma, chronic bronchitis, or emphysema
Section 51727-6

Inactive ingredients 

Artificial and natural flavor, citric acid, FD&C Blue #1, FD&C Red #40, hydroxyethylcellulose, L-menthol, methylparaben, propylen glycol, propylparaben, purified water, sodium citrate, sucralose, and sucrose. 

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-516-341-0666 8:30 am - 4:30 pm EST Mon-Fri

Section 53414-9

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

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active Ingredients (in each 20 mL)

Dextromethorphan HBr 20mg

Guaifenesin 400 mg


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 drain bronchial tubes
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL = mililiters
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

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 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.

When using this prodcut, do not use more than directed.

Section 50569-3 (50569-3)

Ask a doctor before us if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking,asthma, chronic bronchitis, or emphysema
Section 51727-6 (51727-6)

Inactive ingredients 

Artificial and natural flavor, citric acid, FD&C Blue #1, FD&C Red #40, hydroxyethylcellulose, L-menthol, methylparaben, propylen glycol, propylparaben, purified water, sodium citrate, sucralose, and sucrose. 

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-516-341-0666 8:30 am - 4:30 pm EST Mon-Fri

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active Ingredients (in each 20 mL)

Dextromethorphan HBr 20mg

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)