NIGHTTIME COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]

NIGHTTIME COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]
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NDC 76168-056-02
Set ID 516fc924-61f0-40ee-9688-3c6da817b462
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active Ingredient

    (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine Succinate 6.25 mg

  • Purpose

    pain reliever

    Cough Suppressant

    Antihistamine

  • Uses

    pain reliever, cough suppressant and Antihistamine

  • Warnings

    Warnings Failure to follow these warnings could result in serious consequences.

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses in 24 hours which is maximum daily amount for this product
    • 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 not prescription). 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 your 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
  • Keep out of reach of children.

    If pregnant or breast-feeding, ask a health professional before use.

    Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

  • Direction

    • do not exceed 4 doses per 24 hours
    • take only as directed – see overdose warning
    • Adults and children 12 years and over: 2 softgels with water every 4 hours
    • children under 12 years: ask a doctor
    • Children under 4 years: do not use
  • Other Information

    • store at room temperature
  • Inactive Ingredients

    FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

  • Questions or Comments

    Call toll free 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    311d7647-figure-01

    NDC: 76168-056-02   12 softgels

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU 
    acetaminophen,dextromethorphan,doxylamine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-056
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code 215
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-056-0212 in 1 BLISTER PACK08/01/2017
    11 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2014
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)
    Establishment
    NameAddressID/FEIBusiness Operations
    medgel677385498manufacture(76168-056)

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