Label: DAYTIME SINUS AND CONGESTION- acetaminophen, phenylephrine hydrochloride capsule, liquid filled

  • NDC Code(s): 51013-159-04
  • Packager: PuraCap Pharmaceutical LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 26, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

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  • Purposes

    Pain reliever/Fever reducer

    Nasal decongestant

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  • Uses

    • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • nasal congestion
    • sinus congestion & pressure
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion & pressure
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  • 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


    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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  
    • high blood pressure            
    • thyroid disease
    • diabetes  
    • trouble urinating due to 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 use more than directed.  

    Stop use and ask a doctor if

    • 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
    • you get nervous, dizzy or sleepless

    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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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  • Directions

    • take only as directed 
    • do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

         2 softgels with water every 4 hrs

    children 4 to under 12 yrs

         ask a doctor

    children under 4 yrs

         do not use

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  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
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  • Inactive ingredients

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

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  • Questions or comments?

    Call toll free: 1-855-215-8180

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  • PRINCIPAL DISPLAY PANEL

    Daytime Sinus & Congestion  24 SOFTGELS

    NDC 51013-159-04

    Compare to Vicks® QlearQuil® Daytime Sinus & Congestion active ingredients*

    PV Daytime Sinus and Congestion 24ct

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  • INGREDIENTS AND APPEARANCE
    DAYTIME SINUS AND CONGESTION 
    acetaminophen, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-159
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color orange (clear) Score no score
    Shape capsule (oblong) Size 19mm
    Flavor Imprint Code PC12
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51013-159-04 2 in 1 CARTON 07/26/2016
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/26/2016
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    Name Address ID/FEI Business Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture(51013-159) , analysis(51013-159)
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