Sinus Congestion and Pain

Manufacturer
FRED'S, INC. | LNK International, Inc.
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 23:16:20

Label at a glance#

ProductSinus Congestion and Pain Non-Drowsy
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 10 gelcaps 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) avoid high humidity see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredients (in each gelcap)

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 respiratory allergies, and the common cold:
    • headache
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • 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 in 24 hours, which is the maximum daily amount
  • 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

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

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 of 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 (1-800-222-1222) 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 take more than directed
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 10 gelcaps 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)
  • avoid high humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's®
Pharmacy

NDC 55315-558-08

Daytime Non-Drowsy

SINUS
CONGESTION & PAIN
Acetaminophen
- Pain Reliever/Fever Reducer
Phenylephrine HCl - Nasal Decongestant

  • Headache
  • Nasal Congestion
  • Sinus Congestion & Pressure

24 RAPID RELEASE
GELCAPS

Compare to the active ingredients in:
Tylenol® SINUS +
HEADACHE Day*

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 McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS + HEADACHE Day.
50844      REV0216C55808

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
          guaranteed
Questions or comments: 1-855-331-FRED (3733)

Freds 44-558
Freds 44-558

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
CROSPOVIDONEINACTIVE INGREDIENT68401960MK2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-55855315-558-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 277 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48GRANULE / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii candidate
27 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
31 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / RECTALNAExact identifier — unii candidate
31 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCONCENTRATE / ORAL0.03 mg/1mlExact identifier — unii candidate
31 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
31 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, COATED PELLETS / ORAL41.4 mgExact identifier — unii candidate
27 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE / ORAL72 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TRANSDERMAL20 mgExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, COATED / ORAL2.5 mgExact identifier — unii candidate
31 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PLOTION, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TOPICAL222 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GELIXIR / ORAL0.3 mg/15mlExact identifier — unii candidate
31 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGRANULE / ORAL13 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, COATED PELLETS / ORAL198 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GLOTION / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates

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
0da70fb1-32c9-408c-a72c-b012309dfae75ce081f7-5f8b-4534-a998-622d7d032d5b2020-09-02WarningsExact identifier
spl id: 0da70fb1-32c9-408c-a72c-b012309dfae7
spl set id: 5ce081f7-5f8b-4534-a998-622d7d032d5b

Reported adverse events (FAERS/openFDA)#

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