FDA.reportPublic FDA data

Sinu-Phen Plus

Manufacturer
Wildman Business Group | Allegiant Health | Medique Products | Prestige Packaging
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:07

Label at a glance#

ProductSinu-Phen Plus Sinus Pain and Pressure
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

PURPOSE

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Nasal decongestant

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses

temporarily relieves these common cold/flu symptoms:

nasal congestion

headache

minor aches and pains

stuffy nose

sinus congestion and pressure

temporarily reduces fever

WARNINGS

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

DO NOT USE

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • for more than 10 days unless directed by a doctor

ASK DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

WHEN USING

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms appear

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

QUESTIONS

OTC - QUESTIONS SECTION

Questions or comments? (888) 602-0288

PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProvisionPlus

Sinu-Phen Plus

Sinus Pain & Pressure Relief

Fast Relief of:

  • Fever
  • Nasal Congestion
  • Body Aches
  • Sinus Pain

250 tablets

2 Per Packet

PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label
PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101534acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1101534acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1101534APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-2546-1Sinu-Phen Plus Sinus Pain and Pressure50 in 1 BOXTABLET502
84269-2546-1Sinu-Phen Plus Sinus Pain and Pressure2 in 1 PACKETTABLET22
84269-2546-2Sinu-Phen Plus Sinus Pain and Pressure2 in 1 PACKETTABLET22
84269-2546-2Sinu-Phen Plus Sinus Pain and Pressure125 in 1 BOXTABLET1252

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84269-254684269-2546-2, 84269-2546-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSPOVIDONE (120 .MU.M)68401960MKIACT
POVIDONEFZ989GH94EIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSES3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

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
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
ndc (package): 84269-2546-1
ndc (package): 84269-2546-2
ndc (product): 84269-2546
ndc11 (package): 84269254602
ndc11 (package): 84269254601
spl id: aa5b4b7d-a79e-4392-a493-da94b1c790d4
spl set id: c66e0b52-5531-4a84-ae90-8a26d27df1ec

Reported adverse events (FAERS/openFDA)#

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