Rabofen™ Dm

Rabofen™ Dm
SPL v5
SPL
SPL Set ID 2ed83edb-d48e-4958-adc9-0c9092dd8ec5
Route
ORAL
Published
Effective Date 2020-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Sodium Benzoate Saccharin Sodium Anhydrous Citric Acid Glycerin Menthol, Unspecified Form Water Corn Syrup Prunus Serotina Bark Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2004-01-01
Description

Drug Facts

How Supplied

Product: 50090-2657 NDC: 50090-2657-0 118 mL in a BOTTLE

Medication Information

How Supplied

Product: 50090-2657

NDC: 50090-2657-0 118 mL in a BOTTLE

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

Keep out of the 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 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 53414-9

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

Section 55105-1
Active ingredients (in each 2 TSP (10 mL)) Purposes
Dextromethorphan HBr, USP 20 mg Cough suppressant
Guaifenesin, USP 200 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup only. Do not use any other device.
  • this adult product is not intended for use in children under 12 years of age
  • TSP=teaspoonful
adults and children 12 years and over 2 TSP every 4 hours
children under 12 years do not use
Tamper Evident

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing

Other Information
  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate
Inactive Ingredients

artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments?

(800)-616-2471

Ask A Doctor Before Use If You Have
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus).
Dextromethorphan Hydrobromide and Guaifenesin

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the 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 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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 2 TSP (10 mL)) Purposes
Dextromethorphan HBr, USP 20 mg Cough suppressant
Guaifenesin, USP 200 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup only. Do not use any other device.
  • this adult product is not intended for use in children under 12 years of age
  • TSP=teaspoonful
adults and children 12 years and over 2 TSP every 4 hours
children under 12 years do not use
How Supplied (HOW SUPPLIED)

Product: 50090-2657

NDC: 50090-2657-0 118 mL in a BOTTLE

Tamper Evident (TAMPER-EVIDENT)

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing

Other Information (Other information)
  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments? (Questions or comments?)

(800)-616-2471

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus).
Dextromethorphan Hydrobromide and Guaifenesin (Dextromethorphan Hydrobromide and GUAIFENESIN)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.799843 · Updated: 2026-03-14T22:55:53.187482