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DayTime Sinus Relief (Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.)

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CAPSULE, LIQUID FILLED 1 BAG in 1 BOX (53345-012-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG Label Information

Complete DayTime Sinus Relief Information

  • Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg


  • Purpose

    Pain reliever

    Nasal decongestant


  • Uses

    temporarily relieves sinus symptoms:

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

    If pregnant or breast-feeding, ask a health 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

    • take only as directed - see Overdose warning
    • do not exceed 4 doses per 24 hours

    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
    • when taking NIGHTTIME and DAYTIME products, carefully read each label to insure correct dosing

  • Other information

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

  • Inactive ingredients

    FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
    Wuhan, Hubei
    430206, China


  • PRINCIPAL DISPLAY PANEL - Shipping Label

    DayTime Sinus Relief Capsules

    Quantity : 4000 Capsules
    NDC. No : 53345-012-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

    PRINCIPAL DISPLAY PANEL - Shipping Label

  • INGREDIENTS AND APPEARANCE
    DAYTIME SINUS RELIEF 
    acetaminophen, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-012
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color orange Score no score
    Shape CAPSULE (oblong) Size 21mm
    Flavor Imprint Code PC12
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53345-012-01 1 in 1 BOX
    1 4000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    Name Address ID/FEI Business Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-012) , ANALYSIS(53345-012)