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Day relief sinus PE (Western Family Foods, Inc.)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 CARTON (55312-100-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 1 BLISTER PACK in 1 CARTON (55312-100-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Day relief sinus PE Information

  • 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 4,000 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.

    Ask a doctor before use if you have
    • liver disease
    • diabetes
    • heart disease
    • thyroid disease
    • 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 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 or 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.

    Overdose warning: Taking more than the recommended dose can 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 use more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

  • Other information

    • store at room temperature15º-30ºC (59º-86ºF)
    • avoid excessive heat

  • Inactive ingredients

    edible ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


  • Questions or comments?

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


  • Principal Display Panel

    LIQUID CAPS

    DayRelief Sinus PE

    NON-DROWSY RELIEF OF YOUR WORST SINUS SYMPTOMS

    ACETAMINOPHEN 325 mg, PHENYLEPHRINE HCl 5 mg

    PAIN RELIEVER, NASAL DECONGESTANT

    RELIEVES SINUS PRESSURE, SINUS HEADACHE, SINUS CONGESTION

    COMPARE TO VICKS® DAYQUIL® SINEX® LIQUICAPS® active ingredients*

    SOFTGELS

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

    Proudly distributed by Western Family Foods, Inc.

    P.O Box 4057, Portland, OR 97208 USA

    www.westernfamily.com

    Product of Canada


  • Product Label

    Acetaminophen 325 mg, Phenylephrine HCl 5 mg

    Western Family DayRelief Sinus PE Softgel


  • INGREDIENTS AND APPEARANCE
    DAY RELIEF SINUS PE 
    acetaminophen and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color ORANGE Score no score
    Shape CAPSULE Size 20mm
    Flavor Imprint Code 48A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-100-12 1 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:55312-100-16 2 in 1 CARTON
    2 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/10/2012
    Labeler - Western Family Foods, Inc. (192166072)