Sinus Pressure and Pain

Manufacturer
Family Dollar Services Inc | LNK International, Inc.
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:54

Label at a glance#

ProductSinus Pressure and Pain
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever 

Dosage and administration

do not use more than directed  adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN  store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    • minor aches and pains
    • nasal congestion
    • headache
    • sinus congestion and pressure
  • promotes sinus drainage
  • temporarily reduces fever 

Warnings

WARNINGS SECTION

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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • diabetes
  • liver disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • 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 occur

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed 
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
Wellness™

COMPARE TO THE
ACTIVE INGREDIENTS
IN SUDAFED PE® SINUS
PRESSURE + PAIN*

MAXIMUM STRENGTH
SINUS
PRESSURE & PAIN

Acetaminophen
Phenylephrine HCl
Pain Reliever/Fever Reducer
Nasal Decongestant

RELIEVES:
• Sinus Pressure & Congestion
• Sinus Headache

Pseudoephedrine free

24 CAPLETS

NON
DROWSY

ACTUAL SIZE

NDC 55319-702-08

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark SUDAFED PE® SINUS
PRESSURE + PAIN.
50844         ORG082050208

DISTRIBUTED BY: MIDWOOD BRANDS LLC,
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

NOT 100% SATISFIED?
Return within 30 days to the store of purchase
for a refund (with receipt) or exchange.

Family Wellness 44-502
Family Wellness 44-502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN3
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251923975GTIN-13: 0032251923975
EAN-13: 0032251923975
GTIN-12: 032251923975
UPC-A: 032251923975
GTIN storage (14 digits): 00032251923975
family-wellness-44-502-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-702-08Sinus Pressure and Pain2 in 1 CARTONTABLET23
55319-702-08Sinus Pressure and Pain12 in 1 BLISTER PACKTABLET123

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-70255319-702-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
ndc (package): 55319-702-08
ndc (product): 55319-702
ndc11 (package): 55319070208
spl id: 53caa925-c81f-46ec-9542-202a8d8d7eeb
spl set id: 0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2

Reported adverse events (FAERS/openFDA)#

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