NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]

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  • NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]

NIGHT TIME SINUS AND CONGESTION (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-733-16
Set ID 842706f9-eedf-1783-49ed-e6b7ae7d650e
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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  • Active ingredient(s)

    Acetaminophen 325 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/Fever reducer

    Antihistamine

    Nasal decongestion

  • Uses

    • temporarily relieves symptoms due to common cold
    • minor aches and pains
    • headache
    • fever
    • runny nose and sneezing  
    • nasal congestion
    • sinus congestion & pressure
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
    • minor aches and pains
    • headache
    • runny nose and sneezing
    • itching of the nose or throat, and itchy, watery eyes
    • nasal congestion
    • sinus congestion & pressure

  • 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 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.
    • to make a child sleep

    Ask a doctor before use if

    • liver disease
    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use ifyou are

    • taking sedatives or tranquilizers   
    • taking the blood thinning drug warfarin

    When using this product

    • do not use more than directed
    • 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 & tranquilizers may increase drowsiness

    Stop use and ask 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 as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed
    • take only as directed

    adults & children 12 years & over

    		2 Liquid Caps with water every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

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

  • Inactive ingredients

    edible white ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol

  • Questions or comments? 

    1-800-706-5575

  • Principal Display Panel

    Premier Value

    Nighttime Sinus and Congestion

    NDC number 68016-733-16

    16 Liquid Capsule

    sinus-congestion-nighttime-16count-ctn

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME SINUS AND CONGESTION 
    acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-733
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE K12 (UNII: 333AG72FWJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 47A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-733-168 in 1 BLISTER PACK
    12 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/12/2015
    Labeler - Chain Drug Consortium, LLC (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Limited248441727analysis(68016-733) , manufacture(68016-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Limited Strathroy243944050analysis(68016-733) , manufacture(68016-733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Legacy Pharmaceutical Packaging969852743pack(68016-733)
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