Sorbugen

Dextromethorphan hydrobromide, glycerol guaiacolate · Syrup · Oral

Over the counter Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist 1 recall

Active ingredient

Active Ingredients (in each 7.5 mL, 1 ½ teaspoon) Dextromethorphan HBr, 15 mg Guaifenesin (Glyceryl Guaiacolate), 150mg

Purpose

Purposes Antitussive Expectorant

Uses

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, drain bronchial tubes, and make coughs more productive

Warnings

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

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.

Directions

Directions
• do not take more than 6 doses in any 24-hour period.
• mL = milliliter
• tsp = teaspoon age dose Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours Children under 12 years of age Consult a physician

Other information

Other information Tamper evident feature: Do not use if printed security seal is torn, broken or missing. Store at controlled room temperature 15-30°C (59-86°F). Avoid excessive heat or humidity.

Inactive ingredients

Inactive Ingredients Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions?

Questions or comments? 1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

Label text from the FDA structured product label by Kramer Novis (revised Nov 12, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Sorbugen NDC products (1)

NDCStrength & formLabelerType
52083-660Dextromethorphan Hydrobromide 15 mg/7.5mL; Guaifenesin 150 mg/7.5mL
Syrup
Kramer NovisOTC MONOGRAPH DRUG

Sorbugen recalls

Frequently asked questions

What is Sorbugen used for?

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, drain bronchial tubes, and make coughs more productive

Who makes Sorbugen?

Sorbugen is listed by 1 labeler in the FDA NDC directory, including Kramer Novis.

Has Sorbugen been recalled?

The FDA enforcement database lists 1 recall for Sorbugen, most recently D-1505-2019 (class ii): CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing…