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day relief night relief sinus pe (Western Family Foods Inc)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CARTON (55312-515-05) * 2 BLISTER PACK in 1 KIT > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete day relief night relief sinus pe Information

  • Active ingredient for Nighttime Sinus (in each softgel)

    Acetaminophen 325 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg


  • Active ingredient for Daytime Sinus (in each softgel)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg


  • Purpose (for Nighttime Sinus)

    Pain reliever

    Antihistamine

    Nasal decongestant


  • Purpose (for Daytime Sinus)

    Pain reliever

    Nasal decongestant


  • Uses

    temporarily relieves nasal and sinus symptoms:

    • sinus pain
    • headache
    • nasal and sinus congestion
    • runny nose and sneezing (Nighttime Sinus only)

  • Warnings

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 12 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using these products

    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.
    • to make a child sleepy

    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
    • a breathing problem such as emphysema or chronic bronchitis (Nighttime Sinus only)
    • glaucoma (Nighttime Sinus only)

    Ask a doctor or pharmacist before use if you are
    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using these products
    • do not use more than directed

    In addition, when using Nighttime Sinus:

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    • redness or swelling is present
    • pain or nasal congestion gets worse or lasts more than 7 days
    • you get nervous, dizzy or sleepless
    • fever gets worse or lasts more than 3 days
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Directions

    • take only as recommended - see Liver warning
    • do not exceed 6 doses per 24 hours

    Nighttime Sinus

    adults and children 12 years and over

    2 softgels with water every

    4-6 hours
    children 4 to under 12 years ask a doctor
    children under 4 years do not use

    Daytime Sinus

    adults and children 12 years and over

    2 softgels with water every

    4 hours
    children 4 to under 12 years ask a doctor
    children under 4 years do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

  • Other information

    • store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    Nighttime Sinus edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

    Daytime Sinus edible ink, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


  • Package/Label Principal Display Panel

    SAVE when you buy DAY and NIGHT SINUS RELIEF

    See New Warnings Information

    LIQUID CAPS

    Day Relief Sinus PE

    NON-DROWSY RELIEF OF YOUR WORST SINUS SYMPTOMS

    PAIN RELIEVER, NASAL DECONGESTANT

    RELIEVES SINUS PRESSURE, SINUS HEADACHE, SINUS CONGESTION

    ACETAMINOPHEN, PHENYLEPHRINE HCl

    ALCOHOL FREE

    ANTIHISTAMINE FREE

    COMPARE TO VICKS® DAYQUIL® SINUS active ingredients

    See New Warnings Information

    LIQUID CAPS

    Night Relief Sinus PE

    NIGHTTIME RELIEF OF YOUR WORST SINUS SYMPTOMS

    PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT

    RELIEVES SINUS PRESSURE, SINUS HEADACHE, SINUS CONGESTION

    ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl

    ALCOHOL FREE

    COMPARE TO VICKS® NYQUIL® SINUS active ingredients

    Day Relief Sinus PE and Night Relief Sinus PE Carton Image 1

    Day Relief Sinus PE and Night Relief Sinus PE Carton Image 1

    Day Relief Sinus PE and Night Relief Sinus PE Carton Image 2

    Day Relief Sinus PE and Night Relief Sinus PE Carton Image 2


  • INGREDIENTS AND APPEARANCE
    DAY RELIEF NIGHT RELIEF SINUS PE 
    acetaminophen, doxylamine succinate , phenylephrine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-515
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-515-05 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BLISTER PACK 20 
    Part 2 2 BLISTER PACK 20 
    Part 1 of 2
    NIGHT RELIEF SINUS PE 
    acetaminophen, doxylamine succinate , phenylephrine hcl capsule, liquid filled
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color BLUE (transparent) Score no score
    Shape CAPSULE (softgel) Size 20mm
    Flavor Imprint Code L247
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 KIT
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/16/2007
    Part 2 of 2
    DAY RELIEF SINUS PE 
    acetaminophen, phenylephrine hcl capsule, liquid filled
    Product Information
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color ORANGE (light;transparent) Score no score
    Shape CAPSULE (softgel) Size 20mm
    Flavor Imprint Code L565
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 2 in 1 KIT
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/16/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/16/2007
    Labeler - Western Family Foods Inc (192166072)