MULTI-SYMPTOM NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]

MULTI-SYMPTOM NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]
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NDC 68210-0105-1
Set ID 6e980c7c-23bb-4c89-b503-0f92fcf0892c
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan Hydrobromide 15 mgCough suppressant
    Doxylamine Succinate 6.25 mgAntihistamine
  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches/pains
    • fever
    • runny nose and sneezing
  • 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

    Sore throat warning

    If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

    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 you have

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you 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 with driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • pain or cough 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
    • cough comes back or occurs with rash, or headache that lasts. These could be signs of a serious condition

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

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose 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 as well as for children, even if you do not notice any signs or symptoms.

  • Directions

    • Take only as recommended—see Overdose warning.
    • do not exceed 4 doses per 24 hours
      adults and children 12 years of age and overswallow 2 softgels with water every 6 hours
      children 4 to under 12 years of ageask a doctor
      children under 4 years of agedo not use

    If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
    • this product does not contain phenylpropanolamine
  • Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 10 Capsule Blister Pack Carton

    ASSURED

    COMPARE TO ACTIVE INGREDIENTS IN
    VICKS® NYQUIL®*

    MULTI-SYMPTOM

    NiteTime

    Liquid Capsules

    • Acetaminophen - Pain Reliever / Fever Reducer
    • Dextromethorphan HBr - Cough Suppressant
    • Doxylamine Succinate - Antihistamine

    Fever, Headache, Sore Throat,
    Coughing, Minor Aches and Pains,
    Runny Nose & Sneezing

    Actual Size

    10 softgels

    Principal Display Panel - 10 Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM NITETIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0105
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULE (SOFTGELS) Size20mm
    FlavorImprint Code 215
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0105-11 in 1 CARTON02/20/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/20/2016
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LTD677385498manufacture(68210-0105)

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