Drugplain

Niaflu 20 mg/1

Dextromethorphan HBr, Guaifenesin · CAPSULE, LIQUID FILLED · Pharmadel LLC

No Recall History
Plain English

Niaflu is a capsule, liquid filled containing dextromethorphan hbr, guaifenesin at 20 mg/1, taken oral. Manufactured by Pharmadel LLC.

Key Facts

Brand Name
Niaflu
Generic Name
Dextromethorphan HBr, Guaifenesin
NDC Code (Product)
55758-507
Manufacturer
Pharmadel LLC
Strength
20 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
07/10/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

dehydration1 reports
drug ineffective1 reports
dry skin1 reports
feeling hot1 reports
hyperhidrosis1 reports
limb discomfort1 reports
speech disorder1 reports
tremor1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily alleviates common cold/flu symptoms: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes make coughs more productive

Dosage & Administration

Directions do not take more than 6 softgels in a 24 hour period Age Dose adults and children 12 years and older 1 softgel, every 4 hours children under 12 years 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 a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, 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 Niaflu used for?

Niaflu contains Dextromethorphan HBr, Guaifenesin. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Niaflu a controlled substance?

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

What is the generic name for Niaflu?

The generic name for Niaflu is Dextromethorphan HBr, Guaifenesin. There are 12 other brand versions of Dextromethorphan HBr, Guaifenesin.

What is the NDC code for Niaflu 20 mg/1?

The NDC (National Drug Code) for Niaflu 20 mg/1 is 55758-507, listed by Pharmadel LLC.