Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 51b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b
Route
ORAL
Published
Effective Date 2022-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Glycerin Menthol Water Sorbitol Solution 70% Sodium Citrate Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-11-11
Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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
Section 51945-4

Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL= milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years: do not use
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.

Other Information
  • Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
  • store between 20-25ºC(68-77ºF). Do not refrigerate
Inactive Ingredients

acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

Questions Or Comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

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.

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 right away (1-800-222-1222).

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Ask A Doctor Before Use 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

Structured Label Content

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
Section 51945-4 (51945-4)

Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL= milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years: do not use
Do Not Use (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.

Other Information (Other information)
  • Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
  • store between 20-25ºC(68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

Questions Or Comments? (Questions or comments?)

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

Stop Use and Ask A Doctor If (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.

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 right away (1-800-222-1222).

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.878837 · Updated: 2026-03-14T23:00:47.249871