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Sinus Congestion and Pain Non-Drowsy

Medically reviewed on Feb 13, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-558

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Freds Pharmacy 44-558

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

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

Warnings

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
  • 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
  • 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

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if
  • 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,

ask a health professional before use.

Keep out of reach of children.

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
  • 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
  • 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

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?

1-800-426-9391

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

Freds 44-558


SINUS CONGESTION AND PAIN  NON-DROWSY
acetaminophen and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-558
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STEARIC ACID 
TITANIUM DIOXIDE 
CROSPOVIDONE 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorRED, GREENScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;8
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-558-082 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/17/2008
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-558)

 
FRED'S, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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