Skip to Content

← See all Sinus Congestion and Pain Non-Drowsy brands

Sinus Congestion and Pain Non-Drowsy

Medically reviewed on March 1, 2018

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-466

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 44-466C-Delisted

Active ingredients
(in each caplet)

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
    • sinus congestion and pressure
    • nasal congestion
    • 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. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

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

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 day
  • redness or swelling is present

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets 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) 
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

fred's®

Daytime
Pseudoephedrine Free

Actual Size

Non-Drowsy
Sinus
Congestion & Pain
Acetaminophen, Phenylephrine HCl

Pain reliever/fever reducer
Nasal decongestant

For Relief of:
Sinus Headache and Pressure
Nasal Congestion

24 Cool Caplets
with Cool Blast Flavor

fred's
LAB TESTED
Lab Tested for Quality,
Fred Tested for Satisfaction

Compare to the
active ingredients in:
Tylenol® Sinus
Congestion & Pain Daytime*

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

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

fred'sPromise
Not Happy With This Product?
Just Bring It Back For a Refund!

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Sinus Congestion & Pain Daytime.
50844      REV0514F46608

Freds 44-466C-SC

SINUS CONGESTION AND PAIN  NON-DROWSY
acetaminophen and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-466
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
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize17mm
FlavorMENTHOLImprint Code44;466
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-466-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/200507/19/2019
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-466)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-466)

 
FRED'S, INC.

← See all Sinus Congestion and Pain Non-Drowsy brands

Further information

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

Hide