FDA.reportPublic FDA data

Niaflu

Manufacturer
Pharmadel LLC
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:13

Label at a glance#

ProductNiaflu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and 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 and administration

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

Label contents#

Full prescribing information#

Active Ingredients and Purposes

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purposes
Dextromethorphan HBr 20 mg ......Cough suppressant
Guaifenesin 400 mg .....Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 softgels in a 24 hour period
AgeDose
adults and children 12 years and older1 softgel, every 4 hours
children under 12 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • store between 68-77°F (20-25°C)
  • do not use if blister pack is torn or punctured

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. by/ por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE, 19720

+1-866-359-3478

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Niaflu PDPNiaflu PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN2
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-507-01Niaflu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
55758-507-01Niaflu1 in 1 CARTONCAPSULE, LIQUID FILLED12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-50755758-507-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
GELATIN2G86QN327LIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
1,4-SORBITANAV0YTZ4E6JIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
ndc (package): 55758-507-01
ndc (product): 55758-507
ndc11 (package): 55758050701
spl id: 4628aefb-6ec6-af1b-e063-6294a90a1f86
spl set id: 399898f0-e40a-4f5d-e063-6294a90a667d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.