Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

Sinus Congestion and Pain Daytime

Dosage form: capsule
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: NASH-FINCH COMPANY
NDC Code: 70253-558

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.

Our Family 44-558 Delisted

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Nasal decongestant

Uses
  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • nasal congestion
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages

Warnings

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

  • more than 12 gelcaps 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

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. 

Ask a doctor before use if
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if
  • 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 of lasts more than 3 days
  • 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 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 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Other information
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, croscpovidone, 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

Principal Display Panel

Headache
Sinus Pressure
Nasal Congestion
Non-Drowsy

Compare to the Active Ingredients in Tylenol® Sinus Congestion & Pain Daytime*

Our Family®
Quality Care Since 1904

DAY
Sinus
Congestion & Pain
Acetaminophen
- Pain Reliever
Phenylephrine HCl - Nasal Decongestant

QUICK RELEASE

24 GELCAPS

Does Not Contain Pseudoephedrine

TAMPER EVIDENT: DO NOT USE IF CARTON 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 Congestion & Pain Daytime.

DISTRIBUTED BY NASH FINCH COMPANY (c)2004, 1996 NFC BRANDS
7600 FRANCE AVE S, MPLS, MN 55435
www.ourfamilyfoods.com    NF18893
50844    REV0712B55808

Our Family 44-558

SINUS CONGESTION AND PAIN DAYTIME 
acetaminophen and phenylephrine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70253-558
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 (TYPE H) 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeL;8
Contains    
Packaging
#Item CodePackage Description
1NDC:70253-558-082 BLISTER PACK in 1 CARTON
112 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/17/200804/02/2018
Labeler - NASH-FINCH COMPANY (006962294)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70253-558)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70253-558)

Revised: 10/2015
 
NASH-FINCH COMPANY

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide