DAY RELIEF SINUS PE- acetaminophen and phenylephrine hydrochloride capsule, liquid filled 
Western Family Foods, Inc.

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.

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Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever

Nasal decongestant

Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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 you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • 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 the recommended dosage

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • symptoms do not get better within 7 days or are accompanied by a fever

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed (see Overdose warning)
  • do not exceed 4 doses in 24 hrs
  • when using other Dayrelief or Nightrelief products, carefully read each label to ensure correct dosing
 adults & children 12 years of age and over Take 2 softgels with water every 4 hours
 children 4 to under 12 years of age ask a doctor
 children under 4 years of age do not use

Other information

  • store at room temperature 15o - 30o C (59o- 86o F) and avoid excessive heat

Inactive ingredients

FD&C Yellow No #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

call 1-503-639-6300 Monday- Friday 8AM- 4PM PST

Principal Display Panel

Compare to Vicks® Dayquil® Sinex® active ingredients*

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® Sinex®

Day relief sinus PE liquid caps

Non- drowsy relief of your worst sinus symptoms

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Proudly distributed by Western Family foods, Inc.

P.O Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Product Label

Western family daytime sinus PE softgels

Day relief sinus PE liquid caps

DAY RELIEF SINUS PE 
acetaminophen and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-100
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
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 48A
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-100-121 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:55312-100-162 in 1 CARTON
28 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/10/2012
Labeler - Western Family Foods, Inc. (192166072)

Revised: 10/2012
 
Western Family Foods, Inc.