TUSSLIN 20 mg/5mL

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride · SYRUP · Kramer Novis

1 Recall on Record

Plain English

TUSSLIN is a syrup containing dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride at 20 mg/5mL, taken oral. Manufactured by Kramer Novis.

Key Facts

Brand Name: TUSSLIN
Generic Name: Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
NDC Code (Product): 52083-624
Manufacturer: Kramer Novis
Strength: 20 mg/5mL
Dosage Form: SYRUP
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 12/03/2025

Recall History

1 Recall on Record

Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

bronchitis1 reports

confusional state1 reports

dyspnoea1 reports

hot flush1 reports

hyperhidrosis1 reports

hypersensitivity1 reports

intentional dose omission1 reports

malaise1 reports

memory impairment1 reports

pain1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to a cold

Dosage & Administration

Directions • do not take more than 6 doses in any 24-hour period • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 teaspoon) every 4 hours children under 12 years of age do not use

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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • 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 • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts for 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.

Frequently Asked Questions

What is TUSSLIN used for?

TUSSLIN contains Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride. It is a syrup taken oral. Consult your doctor for specific uses.

Is TUSSLIN a controlled substance?

TUSSLIN is not classified as a controlled substance by the DEA.

What is the generic name for TUSSLIN?

The generic name for TUSSLIN is Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride. There are 11 other brand versions of Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride.

What is the NDC code for TUSSLIN 20 mg/5mL?

The NDC (National Drug Code) for TUSSLIN 20 mg/5mL is 52083-624, listed by Kramer Novis.

Product NDC

52083-624

Package NDC

52083-624-16

Other Dextromethorphan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)